Takeda Pharmaceuticals U.S.A., Inc. jobs in Raleigh, NC - 121 jobs

Why Us? At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. Summary The Sr. Quality Analyst serves as the primary for customer inquiries, gap assessments, customer audit coordination, and inspection readiness. Additionally, the Sr. Quality Analyst serves as a primary back up for release work for finished product, batch record review, and label preparation. Job Description ESSENTIAL FUNCTIONS: Utilize inventory management systems (BPCS) and other associated quality systems to ensure proper release of product for the Raleigh manufacturing site. Primary point of contact for the Raleigh site for customer inquiries and required documentation for GMP customer requests. Schedule customer audits and coordinate all associated activities, including but not limited to tracking responses and action items to completion. Maintenance of the Site Inspection Readiness Program ADDITIONAL FUNCTIONS: Act as a primary back-up for batch record reviews. This includes providing timely and thorough audits of all product batch records to ensure site compliance with cGMP regulations, picking up all batch records to be audited from the plant and returning all audited records to the plant (minimum is once daily but could require multiple trips), and providing batch record training as needed for all production employees and potential new QA Analysts. Reviews and approves Certificate of Analysis (CoA) documents. Performs administrative activities for the Quality department. This includes ordering supplies and other materials for both, QA and QC as well as filing. Provides support to investigations, both exceptions and OOSs, to support product disposition. Programs label changes and add new codes to the labeling computer Makes, proofs, and records all finished lot labels to meet the production schedule and as requested by production personnel. Issues final product labels and batch records to production. Corresponds with customers via routine customer inquiries. Provides support to intermediate labeling and tank inspections as needed. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Other duties as assigned with or without accommodation. Participates in a certified 5S Workplace System to ensure good housekeeping and organization Prioritizes and plans workload and team assignments to meet all internal and external customer needs for maximum efficiency and accuracy. Effectively trains and works with others in a positive manner. MINIMUM REQUIREMENTS: Education: High School Diploma, GED, or equivalent. Associates of Science (AS) degree in a related field. Bachelors of Science (BS) or equivalent life science degree preferred. Experience: Minimum of three years of experience preferred in a Quality auditing and batch record review role. Preferred Skills/Qualifications: Other Skills/Competencies: Requires thorough knowledge of site quality procedures and GMP to appropriately audit and perform records functions associated with site compliance to FDA regulations. Attention to detail, organization, time management, and effective communication are needed for this position. RELATIONSHIP WITH OTHERS/ SCOPE: Ability to understand the timely nature of work, quick reporting of results, and fast changing of priorities are necessary to complete assigned tasks. Sound judgment must be used in evaluating plant compliance with GMP standards and initiative is required to facilitate changes needed. An error in judgment during audits could result in FDA citations to the company. A good working relationship with various levels of personnel and management. Good coaching skills are required when providing assistance and guidance to site internal auditors. No employees directly reporting to this position. WORKING CONDITIONS: General normal office and meeting room conditions but must complete some routine assignments in plant and non-air conditioned production environment. Ability to adjust schedule as needed to accommodate production, release, shipping needs. Must be willing and able to wear PPE including hard-hat, steel-toed shoes, safety glasses and any other devices or equipment as specified for the position. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

**Why Us?** At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. ** Summary** The Administrative Coordinator provides administrative services and support for the Site Director, SLT and site staff. **Job Description** **ESSENTIAL FUNCTIONS** **:** + Perform administrative duties for Site Director, SLT and other staff members throughout the site. + Develop presentations, spreadsheets and other documents to support SLT and staff. + Coordinate meetings with visitors, customers, site celebrations, etc. Work with other MNK admin resources to organize/schedule site reviews. + Maintain site bulletin/communications boards with required postings. + Print and deliver MASL and Acetic Acid BOLs and track daily shipments to maintain up to date billing. + File and maintain all records for site materials receipts and deliveries including acetic acid, MASL, bulk chemicals, drums, bags, sulfuric acid etc. + Order office supplies for staff and operations teams. + Manage travel and accommodations for SLT and staff. **DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:** + Manage small projects for Site Director, SLT and staff. + Maintain general office system & processes for mail, filing, and office workflow. + Collaborate with Human Resources to plan and coordinate employee engagement events. + Support HR for all new employee orientation processes + Coordinate lunches for site audits, reviews and other company functions. + Coordinate recognition lunches for employee service anniversaries (Quarter Century Luncheon). + Maintain company P Card and monthly reconciliation. + Attend SLT meetings and maintain meeting action log.. + Maintain site organizational chart and employee photo book. **MINIMUM REQUIREMENTS** **:** _Education:_ High School diploma or equivalent required. Associate degree or equivalent experience preferred. _Experience:_ 1 - 3 years of administrative experience in a pharmaceutical manufacturing environment. Experience with meeting/event planning. Experience supporting a Site Director or Executive and an entire site. _Preferred Skills/Qualifications:_ _Other Skills:_ _Competencies:_ Must have exceptional organization and administrative skills. Excellent command of oral and written communications. Requires a mature and self-directing individual, who can handle the wide variety of people and problems inherent in this job with poise and confidence. Ability to develop work when presented a high-level work statement or concept. High proficiency with Microsoft Office suites, (in particularly powerpoint and excel) and various other software tools is essential. Proficient at scheduling WebExs and Teams meetings . Proficient in note taking and a quick study. Trust & Integrity, Interpersonal Savvy, Written Communications, Comfort around Higher Management **RELATIONSHIP WITH OTHERS/ SCOPE:** + Much of the work encountered is of a confidential and/or sensitive nature. Work for the Site Director is of a high priority nature requiring immediate action. Frequent interruptions via telephone or by visitors through the office. + Much of the communications with upper management flows through this position. Correspondence with others requires high accuracy or it can become the basis of lost time, confusion and poor decisions. Reservations and other travel arrangements demand near-perfect performance. + Wide, range of contact with others both within our plant and externally. All calls and visitors to the Site Director pass through this individual. Maturity, knowledge of proper protocol, tact, sensitivity, and good interpersonal relationship skills are necessary. Incumbent must use his/her initiative and judgment to handle or direct to proper individuals problems that develop in the absence of Site Director and plant staff. **WORKING CONDITIONS:** + Most of work is done in an office environment. May be required to go out in the Plant occasionally. + Must be able to handle normal office equipment including computer, copier, and fax machine etc.. + Must be willing and able to wear the required PPE, including hard-hat, steel-toed shoes, safety glasses, and other devices or equipment that is required. **DISCLAIMER** **:** The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. **EEO Statement:** We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Why Us? At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. Summary This position is responsible for operating large scale manufacturing equipment to produce bulk APIs (Active Pharmaceutical Ingredients) in accordance with Company standards and operating procedures. He/she will be responsible for reports and documentation. Must be able to pay attention to detail due to the nature of chemicals and environment he/she will be working in on a daily basis. Job Description ESSENTIAL FUNCTIONS: Operates in a regulated environment and complies with all cGMP and OSHA regulations applicable to manufacturing responsibilities. This includes understanding and following all applicable batch records, standard operating procedures and work instructions, and wearing appropriate personal protective equipment (PPE) Operates and monitors reaction vessels, crystallizers, centrifuges, filters, evaporator, heat exchangers, pumps, valves and other equipment through manual operations, panel boards, indicators, and HMI displays (for PLC and DCS controls) following applicable batch records, procedures, and good documentation practices. Operates and monitors hoists, dryers, mills, sifters, dust collectors, blowers, packaging stations, and other equipment through manual operations, panel boards, indicators, and HMI displays (for PLC controls) following applicable batch records, procedures, and good documentation practices. Packages, weighs, samples, and labels finished goods and intermediate products following applicable batch records, procedures, and good documentation practices. Maintains detailed operating reports and batch records, including notes on problems and records on added weights, volumes, measured temperatures, pH levels, pressures, and flow rates following applicable procedures and as directed by supervisor. Operates forklifts, hoists, and other material handling devices to move bulk raw materials, WIP, and packaged goods to and from pick-up points. Delivers samples to laboratory and retrieves operating supplies from storerooms. Monitors environmental and safety devices (scrubber, rupture discs, relief valves, etc.) to ensure that the equipment is functioning properly. Cleans and maintains work area, process equipment, tools and safety supplies according to regulatory and Company standards and operating procedures. Participates in various employee involvement teams and committees, such as Area/Site Safety Teams, Kaizen events, and Cost Savings Teams, to improve the workplace, increase efficiency, and maximize productivity. Performs Lock Out/Tag Out (LOTO) independently using personal lock. Other duties as assigned by Management. SKILL LEVEL: Has a basic understanding of equipment and processes in their area of responsibility. Can perform basic troubleshooting of equipment or process malfunctions in their area of responsibility. Exercises judgment within defined procedures and practices to determine appropriate actions. TYPICAL DEMONSTRATED PROFICIENCIES: Works toward qualification in either all APAP Wet End operations or all APAP Drying Tower operations. LEADERSHIP RESPONSIBILITIES: No direct responsibility for the work of others Normally receives general instructions on routine work and detailed instructions on new assignments. MINIMUM REQUIREMENTS: Education: High School Diploma, GED, or equivalent required Previous GMP manufacturing experience preferred Experience: Previous experience in a GMP manufacturing environment (preferred) Preferred Skills/Qualifications: Must be able to communicate effectively in both verbal and written formats. Must be able to read and follow detailed instructions and procedures. Must be able to perform basic math. Must have a working knowledge of chemical and/or powder processing equipment and associated safety requirements. Must possess sound problem solving and decision-making skills. Must work in a team environment to perform job tasks and cover workstations during breaks and lunches RELATIONSHIP WITH OTHERS/ SCOPE: Reports to APAP Shift Supervisor in the APAP production department No positions report directly to the APAP Pharmaceutical Operator I Has frequent contact with: APAP production personnel, Quality (QA/QC), Safety and Maintenance WORKING CONDITIONS: Must be able to wear required Personal Protective Equipment (PPE), including hard hat, safety glasses, ear plugs, steel-toe boots, gloves, chemical resistant aprons and suits, and other personal protective equipment deemed necessary. Must be able to lift and carry up to 50 pounds. Material handling devices (e.g., hand truck, fork truck, and conveyors) are used, when possible, but use of proper lifting and movement techniques is necessary to prevent injury. Must be physically able to climb stairs and ladders, roll drums, lift and pour bags of raw materials, drive forklifts, etc. Must be able to work in outdoor conditions as portions of the facility are not climate controlled. Must be able to work rotating 12-hour shifts and overtime as needed. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Why Us? At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. Summary The Sr. Predictive maintenance technician is responsible for executing the sites predictive maintenance program. Duties include collection and analysis of vibration, ultrasound, non-destructive examination and thermographic information for plant equipment, including but not limited to fans, blowers, electrical motors, pumps, gearboxes, compressors and conveyors. Perform precision maintenance on imbalanced fans, misaligned shaft couplings, loose, or weak bases, failed bearings, worn sheaves, improper mountings and improper lubrication. Ensure all plant assets are operating at optimal levels by developing new predictive techniques and programs for plant equipment. Own the lubrication program. Identify optimal operating conditions such as load, speed and environment with the proper lubricant, application frequency, the right amount and correct sealing arrangement in order to achieve the optimum equipment life. Job Description ESSENTIAL FUNCTIONS: Works effectively with Reliability Engineers, Process Managers, and Maintenance leadership to troubleshoot and resolve equipment issues. Uses initiative to seek out root cause of failures and take steps to correct and prevent recurrences. Report on developing fault conditions and provide corrective actions and severity estimates. Coordinate with the Planning group to ensure maintenance requirements are effectively communicated. Assists in the RCFA corrective actions and helps eliminate chronic equipment issues. Schedule and execute routes and inspections to maximize productivity. Solicits recommendations from technicians and mechanics on improving existing procedures, routes, and Standard Job Plans. Assists with perform post failure analysis to verify accuracy of fault identification in order to continuously improve diagnostic skills. Reviews preliminary drawings, specifications, and plans from Engineering for accessibility for predictive and lubrication activities and recommends changes when necessary. Facilitate the maintenance department employees in receiving necessary training to maintain and improve their skill levels. Works to maximize technician flexibility through cross-training. Willingness to continue training as required to remain up to date on techniques, procedures, and practices. Effectively understand and perform IR thermography, Vibration analysis, Ultrasonic scans, and Precision laser alignments. Develop and present technical reports based on field data gathering. Generate corrective work orders in the CMMS system and assign them appropriately for planning and scheduling based on gathered data. Maintain and optimize the vibration analysis database. Performs other duties as assigned by Maintenance management and/or designee. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Other duties as assigned with or without accommodation. Assist CMMS admin with naming coordination between CMMS, P&ID's and field tags. Ability to interact with supervisors, staff, vendors, and the public using a positive collaborative approach. Ability to consistently complete assigned work while attending to multiple tasks and prioritizing projects to meet deadlines as directed. Ability to problem solve and engage necessary staff/supervisors to address emerging facility issues. Initiative and ability to work with minimal direction/monitoring; sound judgment and decision making capabilities are essential. MINIMUM REQUIREMENTS: Education: High School Diploma, GED, or equivalent required. Technical or Associate degree in a related field preferred. Experience: 5+ years experience in maintenance in a manufacturing environment. Must have a thorough knowledge of processes, equipment, and proper safety and environmental practices. Must be familiar with standard operating procedures and process documentation. Must be Vibration Data Collection and Analysis Level II certified Preferred Skills/Qualifications: Other Skills/Competencies: Certifications in infrared and ultrasonic data collection and analysis. Certification in SNT-TC-1A for UT, PT and/or MT. Must be able to effectively communicate in both verbal and written formats. Must have knowledge of basic hand tools. Knowledge of cGMP requirements. Able to plan and execute multiple projects simultaneously. Works well with new technology and computer based data gathering equipment. Must have strong computer skills (Microsoft Office, E-mail, data entry). Learn on the Fly, Organized, Self-Motivated, Action Oriented, Problem Solving RELATIONSHIP WITH OTHERS/ SCOPE: Work is routinely reviewed by site management for adherence to objectives of the site. Advises management on improvement projects and work orders, and safety or environmental hazards. Internal contacts are made on a routine basis with the first line management in the Maintenance, Production, Engineering, Utilities, Warehouse, and Quality Control areas. With the diverse interaction with numerous groups, a tactful and diplomatic approach to communications is necessary in order to achieve the cooperation between individuals and departments. Must be highly organized, self-motivated and have the flexibility to shift priorities quickly in a constantly changing work environment. WORKING CONDITIONS: The plant's open-air construction exposes employees to the normal year-round, outside climate. Some relief from the elements is available in the control rooms, offices, and break area. Dirty conditions and chemical fumes are occasionally present in the work areas. Corrosive, flammable, and toxic material, all which are normally handled in the plant, pose potential leak points for slips, trips and falls. Extra care must be taken while navigating the site. Must handle average to heavy weight materials by hand. Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, but use of proper lifting and movement techniques is necessary to prevent injury. Must be able to physically negotiate stairs and evacuation ladders, to wear and operate safety equipment, enter vessels, inspect equipment, drive forklifts. Must be able to wear the required Personal Protective Equipment (PPE) as deemed necessary by EH&S, leadership team, corporate, or safety guidelines. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary The Quality Tech II analyzes process samples as received and performs non-routine analysis as requested. She/he will analyze finished goods and raw materials by chemical, physical, and instrumental means to ensure quality as needed. She/he will typically work on a rotating shift schedule. Job Description ESSENTIAL FUNCTIONS: Performs in process testing for internal customers. Performs finished goods, returned goods, and stability testing for external customers as needed. Performs specified analysis on all process controls samples and reports in a timely manner by telephone or computer entry using approved written procedures and proper laboratory techniques. Performs specified analysis on all finished goods using approved written procedures and proper laboratory techniques as needed. Maintains accurate and precise records of all laboratory analysis using appropriate Mallinckrodt recordkeeping system. Troubleshoots and performs routine maintenance on laboratory instrumentation. Prepares all standards and reagents needed for proper execution of analytical methods and procedures. Prioritizes and plans workload to meet all internal and external customer needs for maximum efficiency and accuracy. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Assists in any non-routine analytical work needed to solve plant problems. Works on solving problems and implementing improvements in a teaming environment. Uses problem solving skills to help with failure investigations and testing problems. Aids in performing any non-routine quality control related tasks such as resampling, raw material testing, and performing analysis needed to validate methods and equipment. Participates in a certified 5S Workplace System to ensure good housekeeping and organization. Assists with training others as needed. Other duties as assigned with or without accommodation. MINIMUM REQUIREMENTS: Education: Associates of Science (AS) or Bachelor of Science (BS) or equivalent life science degree preferred. Appropriate experience may be a suitable replacement for degree. Experience: 1 - 3 years laboratory experience in a pharmaceutical manufacturing operation preferred. Working knowledge of cGMP is a plus. Expected Skills/Qualifications: Other Skills/Competencies: Must be able to perform basic mathematical calculations. Familiarity with basic laboratory procedures, equipment, and computer key punching. Sound and correct technical judgments are required during routine analysis. High degree of concentration is required. Ability to differentiate colors, as demonstrated by passing a test designed to identify color blindness (such as the Ishihara test). If testing criteria are not met with uncorrected vision, the use of color correcting glasses may be used as long as testing criteria are met while using them. Functional/Technical Skills, Priority Setting, Written Communication Customer Focus, Organizing RELATIONSHIP WITH OTHERS/ SCOPE: Laboratory technicians are responsible for communicating any uncompleted work to the next shift, as well as any immediate priorities. Majority of work is performed independently without direct supervision. Non-routine results, observations, or analytical requests are brought to the attention of the appropriate management personnel. Reports to Quality Testing and Release Manager. Frequent interact with operators, engineers, and Quality management for reporting routine analytical results. Communication may be though radio, telephone, email, or in person. Incorrect or inaccurate analyses can result in possible shipment of reject drug items to Mallinckrodt customers. Customer-requested specifications and Mallinckrodt methods of analysis are considered confidential for marketing purposes. Ability to understand the timely nature of work, quick reporting of results, and fast changing of priorities are necessary to complete assigned tasks. Laboratory employees must be able to work effectively under these conditions. Completes all required Compliance trainings in a timely manner. WORKING CONDITIONS: Most work is performed in a well-equipped analytical laboratory complete with fume hoods, laboratory benches, analytical glassware, and instruments. Boxes of solvents, compressed gas cylinders, old records, and reserve samples are stored in areas outside the laboratory and may require lifting and transporting to the laboratory area. Exposure to fugitive emissions of chemicals typical for chemical operations. Normal dexterity is required for routine handling of laboratory glassware and instruments. Colors must be well-visualized and slight differences in volumes of liquids in appropriate glassware distinguished. Must be able to wear the required personal protective equipment (PPE), such as hard-hat, steel-toe shoes, safety glasses, and other equipment as deemed necessary by EH&S, leadership team, corporate, or safety guidelines for the position. Must be able to work a rotating12 hour shift schedule of (7pm-7am / 7am-7pm) in addition to occasional overtime as needed. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Why Us? At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. Summary SUMMARY OF POSITION: An integral member of the site EHS Department, whose primary responsibilities are to ensure a safe and healthy working environment through training, awareness, and compliance with various environmental, health, safety and security (EHSS) corporate policies, federal regulations, and other generally recognized standards and guidelines. You must possess the proper skills in order to identify hazardous workplace conditions, remove hazards and/or protect employees through development and implementation of Job Safety Analyses (JSA's) and risk assessments, in an effort to continually improve the organization's safety culture. The Sr. EHS Specialist will also assist the Environmental Engineer in the areas of air and water quality type activities as they relate to site activities and operating permits limits. You will be tasked with taking a lead role in revising and improving the site's EHS procedures and management systems. Job Description ESSENTIAL FUNCTIONS: Ensures a safe and quality working environment through training, awareness, and compliance with safety SOP's, corporate standards and OSHA regulations Assist with various EHSS inspections / audits including but not limited to state or federal agencies or required periodic 3rd party audits. Leads efforts as a team member in analyzing and continually improving the site's Safety Culture. Develops and mentors others in developing Job Safety analyses (JSA's) and risk assessments. Monitors and takes effective steps to ensure that workplace conditions comply with applicable federal and state occupational safety and health standards. Ensures that all required records are prepared and maintained. Investigates and prepares required reports on injuries and incidents. Conducts safe work procedures and other safety training courses. Provides input on equipment installation, start-up operation, and trouble shooting. Ensures accountability, transparency, and effective communication cross-functionally and within the safety team and the EHS Department while guaranteeing information is timely, clear and accurate. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Other duties as assigned with or without accommodation. Develop and apply a strong technical knowledge of Albemarle's Policies and Procedures covering Health, Safety and Environment. Other functions may include Regulatory Reporting, Employee training, and assistance contractor management. Key contributor for policy updates, creation, and implementation Document and communicate EHS Expectations, Outcomes and Metrics. Leading planning and execution of Risk Assessments and EHS Audits Required to participate in department on-call schedule. Assists with project reviews for compliance needs. Assists with Emergency Response training and response activities. Be an active member in the site's emergency response Incident Command Team Participate in continuous improvement activities and champion change when faced with adversity while incorporating team input. Supplies the highest level of internal and external customer service while having the ability to diplomatically challenge established procedures and systems. MINIMUM REQUIREMENTS: Education: B.S. degree in Occupational, Safety, and Health Engineering or related safety/technical field. Advanced degree and/or professional certification (CSP, CHMM, CIH, PE) is a plus. Experience: Minimum 5 - 10 years of experience as a EHS professional required. Previous EHS experience in a pharmaceutical, chemical, or manufacturing environment working with hazardous materials preferred. Experience in industrial hygiene monitoring activities, data interpretation and report writing. Experience with internal and external audits and inspections for regulatory compliance. Experience in developing and delivering personnel training Skills/Qualifications: Other Skills: Competencies: Must be able to walk, climb, and wear personal protective equipment (PPE) to include full body suit and respiratory equipment. Working knowledge of Title 29, Code of Federal Regulations Part 1910 and Part 1926; Working knowledge of various North Carolina Division of Environmental Quality regulations as they relate to Air Quality, Water Resources, and Waste Management. Working knowledge of various NFPA, ASME, and similar industry standards/guidelines. Skill in evaluating, planning (including strategic planning), organizing and reviewing regulations to determine compliance with various federal regulatory requirements and corporate EHS policies. Ability to prepare and communicate technical data for use by a variety of different audiences, such as the Site Leadership, supervisors, senior engineers/scientists, technical expert, and operators. Ability to use safety management and engineering practices for the continuous improvement of Plants TRR and workers compensation rates. Excellent communication, interpersonal and technical writing skills. Strong interpersonal skills. Ability to handle multiple priorities. Detail-oriented with the ability to work under tight deadlines. Decision making, problem solving and analytical skills. Conflict management skills. Strong proficiency in Microsoft Office applications required.. Knowledge of FDA's Good Management Practices (cGMP) Ability to effectively communicate with all levels of the organization, from operations to senior management, both oral and written format. Action Oriented, Drive for Results, Problem Solving, Timely Decision Making, Written Communications, Process Management, Time Management, Organizing RELATIONSHIP WITH OTHERS/ SCOPE: This position reports to the EHSS Manager. The Sr. EHS Specialist supports the EHSS goals and functions of the pharmaceutical manufacturing facility. This position interacts with all levels of the facility from production operators to senior site leadership. Ability to effectively interact with manufacturing, maintenance, and medical departments. WORKING CONDITIONS: This position works both in the office and plant setting, both indoors and outdoors. Outdoor conditions will include the temperature and weather extremes. Work outside of normal business hours may be required including working early, staying after normal working hours, weekend work, or holiday work. This position will rotate on-call duties, which include weekend/holiday coverage of plant operations. Physical demands of this job include climbing stairs and extensive periods of walking and standing. Exposure to fugitive emissions of chemicals typical for chemical operations. Must be able don required personal protective equipment (PPE), such as hard hats, safety glasses, safety shoes, flame resistant clothing, respiratory protection, chemical protective suit, etc., as deemed necessary by EHS. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Are you ready to play a pivotal role in transforming demand forecasting within BioPharma ClinOps? As an Associate Principal, Business Analyst, you'll be at the forefront of developing, testing, and implementing FTE demand algorithms using PLANIT, our enterprise project management tool. Collaborate closely with stakeholders across BioPharma ClinOps to ensure alignment with organizational productivity initiatives and drive impactful changes in ways of working. Accountabilities: In this dynamic role, you'll deliver value by managing the BAU process for ongoing review and refinement of functional FTE demand algorithms. You'll develop and manage a roadmap of planned deliveries, ensuring alignment with scorecard objectives and functional needs. Your expertise will ensure that FTE BioPharma ClinOps demand in PLANIT (PLANISWARE Enterprise project management tool), aligns with the current organizational structure and is driven by reliable forecast algorithms. You'll also ensure the impact of productivity initiatives is realized in our demand forecasting, while delivering documentation, communication, and training to support ongoing changes. Essential Skills/Experience: * University degree at Bachelor level, in a scientific or business discipline * 5-10 years of project/portfolio/resource management, in a Clinical Development environment * Broad drug development experience in a matrix environment * Minimum 5 years of working experience and understanding of business planning and capacity management process * Ability to look for and champion more efficient and effective methods/processes * Goal oriented and ability to drive performance * Experience in converting organizational needs into demand algorithms * Experience in developing demand algorithms for Clinical Development * Strong data modelling skills and the ability to transform data into forms easily understood by others * The ability to balance tact, patience and persistence with the need to move improvements at speed * Strong organizational skills to move multiple functions through the improvement processes at different speeds based upon their level of understanding and complexity of their business * Expert knowledge of PLANIT (PLANISWARE Enterprise project management tool), and demand algorithms Desirable Skills/Experience: * Advanced degree * Business relationship management skills * Accredited/Certified in Project Management tools/systems * Proven ability with enterprise project management systems When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca, you'll be part of a team that tackles complex challenges head-on, empowered to innovate and experiment. With access to extensive capabilities and a comprehensive pipeline, you'll engage in diverse projects across the drug development process. Our supportive yet challenging environment fosters continuous learning and improvement, driving us towards groundbreaking solutions that make a tangible difference in patients' lives. Ready to take on this exciting challenge? Apply now and be part of our journey to transform healthcare! Date Posted 02-Jan-2026 Closing Date 30-Jan-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

Why Us? At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. Summary The Quality Control (QC) Manager serves as a Quality Control technical resource to the plant. She/he is the primary point of contact for the testing of all raw materials, in-process, finished goods, and stability samples. She/he manages the Quality Control group and compliance activities to achieve key site and corporate objectives. The Quality Control Manager is responsible for overseeing all QC activities to ensure pharmaceutical products meet regulatory requirements and internal quality standards. This role involves managing QC laboratories, supervising testing processes, and ensuring compliance with Good Manufacturing Practices (GMP) and applicable regulations (FDA, EMA, ICH). This individual will provide overall QC leadership regarding cGMP compliance concerns and improvements, as well as manage budget line items, overtime, efficiency improvements, and staffing. Job Description ESSENTIAL FUNCTIONS: Develop and implement QC policies, SOPs, and testing protocols in compliance with GMP and regulatory guidelines. Oversee analysis of raw materials, in-process samples, and finished products to ensure they meet specifications. Ensure adherence to FDA, EMA, and other regulatory standards, including PIC/S GMP requirements. Maintain accurate records of all QC activities, including test results, deviations, and corrective actions. Manage and train QC staff, assign tasks, and monitor performance to maintain high standards of quality. Identify quality issues, perform root cause analysis, and implement corrective and preventive actions (CAPA). Prepare for and participate in internal and external audits, including regulatory inspections. Oversee calibration, validation, and maintenance of laboratory instruments. Provides subject matter assistance for LIMS, methods, testing, and validation. Manages QC testing group to achieve compliant testing in a timely manner. Manages Lab investigations and OOSs including remediation of potential compliance concerns. Provides overall leadership to QC group regarding cGMP compliance improvement and enhancement. Studies and improves various Quality processes providing increased efficiency or process flow using Lean Manufacturing and/ or Six Sigma philosophy of operation. Drives Quality consistency through reviewing/revising various analytical methods/SOPs to ensure adequacy with special emphasis on actual utility of methods under normal QC conditions. Works with plant Managers/Supervisors and Quality technicians to address any laboratory concerns regarding quality, safety, methods, procedures, or operations. Acts as a liaison between the lab and manufacturing/ R&D for investigations and to implement special projects, assist with validations, method transfers, or technology upgrades. Works with groups to ensure compliance to EHS and departmental safety requirements and provide proactive leadership toward continuous improvement of safety operations in the laboratory. Ensures key turnaround timelines for customer service and compliance requirements are achieved. Performs as a subject matter expert during customer and regulatory audits. Work closely with Production, R&D, and Quality Assurance teams to ensure product quality throughout the lifecycle. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Develops and coaches to build talent. Participate in a 5S Workplace System to ensure good housekeeping and organization. Prioritizes and plans workload and team assignments to meet all internal and external customer needs for maximum efficiency and accuracy. Effectively trains others in a positive manner. Other duties as assigned with or without accommodation. MINIMUM REQUIREMENTS: Education: B.S. /B.A. in Physical Science required. Master's Degree preferred. Experience: 10 - 12 years related experience preferred; at least five years of experience in a supervisory role; strong knowledge of current pharmaceutical cGMP requirements Preferred Skills/Qualifications: Other Skills/Competencies: Complete understanding and application of principles, concepts, practices, and standards for testing performed in all QC laboratories Experience with testing API or Pharma products Experience leading a group of up to 20 people with 24/7 shift operations Excellent written and verbal communication and leadership skills Ability to work in and promote a team environment Working knowledge of Six Sigma and/or Lean manufacturing tools Sense of urgency. Action oriented/drives for results Excellent communication and interpersonal skills Team orientation/strong team player Ability to coach, mentor and teach Excellent decision making, problem solving and analytical skills Strong managerial courage Ability to influence change at all levels of the organization Detail-oriented with the ability to work under tight deadlines Excellent conflict management skills Builds positive relationships with others Excellent time management and prioritization skills Excellent technical writing skills LIMS experience preferred Knows the difference between managing and leading and when to apply each Command Skills, Action Oriented, Conflict Management, Customer Focus, Problem Solving, Priority Setting, Written Communication, RELATIONSHIP WITH OTHERS/ SCOPE: Reports to Site Quality Director Work is performed without appreciable direction Develops strategic objectives for group managed Exercises considerable latitude in determining technical objectives of assignment Completed work is reviewed for desired results from a relatively long-term perspective Bias toward change, management of change, and achievement of results Contact with FDA as subject matter expert during site inspections and customers during frequent customer audits Regular contacts include Quality Assurance, Materials Management, Logistics, Commercial, R&D, Site Production Leaders and EH&S. This position has several direct reports WORKING CONDITIONS: 60% normal office and meeting room conditions. 40% Laboratory and Plant environment including exposure to raw materials and finished products. Must be able wear the required Personal Protective Equipment (PPE) as deemed necessary by EH&S, leadership team, corporate, or safety guidelines. Some off shift and weekend work can be expected; travel requirements are minimal DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary We are seeking a skilled and safety-focused welder to join our team. The ideal candidate will have proven experience in pipe and plate welding along with metal fabrication. S/he has ability to interpret blueprints, project plans, and isometric drawings to complete pipe fitting and welding tasks. S/he must be able to accurately pre-fab and install pipe replacements and upgrades. This role requires strong technical knowledge, attention to detail, and the ability to collaborate with construction and maintenance teams to ensure safe, high-quality project execution. Job Description Blueprint and Drawing creation and interpretation Create, read, and interpret project plans, blueprints, piping diagrams, and isometric drawings. Translate written instructions and diagrams into precise fabrication and installation tasks. Fabrication and Installation Measure, cut, thread, groove, bend, and weld pipes according to specifications. Prefabricate piping systems and confirm alignment, tolerances, and fit prior to installation. Assemble pipes, fittings, and valves using appropriate tools, equipment, and joining techniques. Understanding and experience with carbon steel, stainless steel (304L & 316L), aluminum, and alloy 20 metals, among others. Ensure accurate pipe fit-up and compatibility with structural components. Repair equipment in the field, as needed, including within confined spaces. Testing and Quality Control Inspect and test completed piping systems for leaks, durability, and compliance with industry standards. Identify issues, perform adjustments, and report malfunctions or defects to supervisors. Ensure adherence to project specifications, codes, and safety regulations. Collaboration and Teamwork Work closely with welders, fabricators, and construction crews to ensure seamless project integration. Participate in failure analysis and troubleshooting to address causes of equipment or system failures. Communicate effectively with supervisors, engineers, and team members. Safety and Compliance Support and follow all site safety programs, policies, and guidelines. Wear and maintain all required Personal Protective Equipment (PPE), including full-face respirators, hard hats, safety glasses, gloves, steel-toe boots, and chemical-resistant gear when necessary. Contribute to a safe work environment by practicing proper housekeeping in the shop and on job sites. Equipment and Maintenance Operate and maintain pipefitting machinery and tools (cutting torches, threading machines, grinders, calipers, etc.). Ensure equipment is used safely and kept in good working condition. Report any equipment malfunctions promptly. Requirements Minimum of 2 years' proven experience as a Pipe Fitter. Strong ability to read and work from blueprints, isometric drawings, and piping diagrams. Skilled in pipe fabrication, alignment, and installation processes. Familiarity with welding processes and ability to collaborate with welders during fit-up and installation. Proficiency in using tools and equipment such as cutters, threading machines, torches, squares, and calipers. Ability to pass fit-up or pipefitting assessments as required. Strong attention to detail with a results-driven and safety-focused approach. Physical ability to stand, bend, squat, and lift heavy materials regularly. Must be able to work in varying environmental conditions (indoor/outdoor, hot/cold, confined spaces). Commitment to workplace safety and compliance with all PPE requirements. Preferred Qualifications Experience working on industrial, commercial, or construction piping systems. Knowledge of relevant codes and standards (ASME, ANSI, OSHA, etc.). Ability to weld pipe and plate using GTAW and SMAW methods when required. Demonstrated teamwork and communication skills in a construction or industrial setting. Ability to perform basic NDE techniques, such as visual examination and liquid dye penetrant examination. Work Environment This position involves work in both shop and field settings. Candidates must be able to adapt to changing work environments, including exposure to noise, dust, extreme temperatures, and confined spaces. Pipe Fitters must also be able to work at heights and in physically demanding conditions while maintaining strict adherence to safety standards. Shop and industrial manufacturing areas without climate control. Must be able to go up and down several flights of steps on occasion. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Why Us? At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. Summary The Principal Project Engineer executes entire engineering projects of moderate-to-large size and of a complex nature. Independently performs most assignments with instructions as to what is generally expected. Interaction with the Production, Maintenance, and EHS (Environmental, Health, and Safety) Departments is critical for project success. Job Description ESSENTIAL FUNCTIONS: Works with site departments in establishing scope and objectives of specific projects required to meet the business plan. Works with site personnel to identify customer requirements and establish project objectives. Develops project scope, cost estimates, schedules, and justification into a Capital Expenditure Request (CER). Responsible for capital projects ranging from $10,000 up to $5,000,000 per scope item. Plans, conducts, and supervises assignments for execution of design and construction of major projects for the site. Ensures that projects meet scope, schedule, and budget. Develops and implements department plans for executing capital projects and for providing site technical support. Assists plant management staff in preparation of capital budgets. Updates and reviews project spending forecasts monthly. Assists in development of long-range plans for site capital spending with focus on continuous improvement and cost-savings. Conducts recurring project status review meetings for scope, schedule and cost. Manages resolution of project issues or risks and communicates to stakeholders. Selects and prepares equipment purchase specifications and construction specifications. Performs the necessary reviews and takes action to maintain cost control and schedule control on assigned projects. Updates CERTS forecasting tool monthly. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Other duties as assigned with or without accommodation. Ensures that capital projects are implemented meeting all throughput, mechanical, chemical, quality, and safety standards. Provides technical support as needed for site. Identifies resource needs to meet business objectives. Identifies and implements cost savings. Assists in the budgeting process. Assists in selection of engineering design firms and construction contractors. Serves as consultant to management. MINIMUM REQUIREMENTS: Education: Must hold a B.S. in Chemical Engineering or related discipline. Experience: Minimum of 15 years of experience in production/process engineering design. Project experience is a plus. Preferred Skills/Qualifications: Other Skills: Competencies: 5-10 years of experience in design and construction of projects preferred. P.E. certification is a plus. Must have a broad knowledge of principles and concepts in chemical processing, as well a good working knowledge in related engineering fields. Should be proficient with word processing, spreadsheets, project scheduling, and database software on a PC. Priority Setting, Organizing, Problem Solving, Interpersonal Savvy RELATIONSHIP WITH OTHERS/ SCOPE: Reports to Lead Project Engineer. Significant interaction/communication with all site departments and corporate functions. Outside the company frequently selects/works with engineering design firms, manufacturer's representatives, and construction contractors. Completed work is reviewed in terms of achieving objectives. Technical decisions on complex assignments are tested for soundness of judgment before initiating action. Otherwise operates with latitude for action. WORKING CONDITIONS: Position will work mostly in an office environment. Some work will be in the manufacturing plant, as necessary, to gather information, oversee projects, etc. May be exposed to fugitive emissions of chemicals typical of chemical operations. Must be able to climb stairs and ladders to review equipment during installation and troubleshooting. Must be willing and able to wear PPE including hard hat, steel-toed shoes, safety glasses, hearing protection, and any other devices or equipment that is required. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Why Us? At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. Summary The Sr. Quality Engineer has responsibility for interpreting and applying the applicable regulations and Quality Systems, and developing and implementing standard operating procedures (SOPs) and policies. In a cGMP manufacturing setting, provide Process / Quality Engineering support to all areas of the facility to ensure delivery of the highest quality product to the customer. The Sr. Quality Engineer will provide statistical and process support to assist with continuous improvement activities. Job Description ESSENTIAL FUNCTIONS: The role provides input into regulatory filings as well as guidance for the various elements of the Quality System, including but not limited to the following: Validation, Deviations (Exceptions), Supplier Quality, Product complaints, Internal Audits, OOS, CAPA, Annual Product Review, Process control, Change Control, and identification/ recommendations for continuous improvement opportunities (internal/external). The Sr. Quality Engineer applies the appropriate statistical tools to analyze data, identify root cause and develop corrective actions for effective problem resolution of moderate to difficult scope and complexity. Additional functional requirements: Acts as SME for validation activities. Provides validation guidance and support for computer systems, production processes, and both production and laboratory equipment. Acts as lead for Quality Systems ownership for day to day activities and monthly metrics and trending. Provides guidance and training to Quality Department personnel in all applicable Quality Systems. Leads compliance efforts for the site. Provides direction and leadership for quality system improvements and for benchmarking of other sites to establish and implement best practices. Participates in continuous improvement activities as required. May lead continuous improvement activities (e.g. kaizen). Works within production teams, develop data trending models using appropriate statistical methods and deploy use of them. Analyzes trends related to various activities and identify root causes and areas for improvement. Utilizes output of trend analysis to initiate investigations and or corrective/preventive action projects. Assesses manufacturing and support processes to identify and implement quality minded efficiencies and improvements. Leads or participates in risk analysis activities (FMEA) for changes to production or design processes. Uses process mapping tools to define critical control points and recommend alternatives to reduce risk of defects. Oversees cross functional teams for complaint investigation and resolution. Generates final complaint investigation reports. Leads investigation efforts and accurately document investigation plans, supporting data, and conclusions. Leads corrective and preventive action projects. Participates on extended core teams as a QA representative. Statistical analysis (Excel, Mini-tab, other statistical software). Develops sampling plans, as needed. Provides change management guidance and support. Provides internal / external audit support. May assume the Lead Auditor role. Serves as a subject matter expert for Regulatory and Customer audits. Conduct New Employee orientation. Provides supplier quality oversight, including technical support for supplier selection and supplier quality evaluations as well as the development and management of supplier corrective action plans. Work closely with suppliers to ensure quality expectations and strengthen supplier relationships. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Other duties as assigned with or without accommodation. Participates in a certified 5S Workplace System to ensure good housekeeping and organization. Prioritizes and plans workload and team assignments to meet all internal and external customer needs for maximum efficiency and accuracy. Effectively trains others in a positive manner. MINIMUM REQUIREMENTS: Education: B.S. degree in Engineering or Science or a related field Experience: Minimum of 5 years' experience in QA/pharmaceutical manufacturing environment Preferred Skills/Qualifications: Other Skills/Competencies: Knowledge of regulations associated with ICH Guidelines (Q7, Q8, Q9, and Q10), FDA, EMA, USP, EP, and JP. Direct interactions with regulatory inspections. Strong technical, oral, and written communication skills. Able to speak, read, and write the English language. Knowledge of Six Sigma Tools or certification. Good project management, problem solving, team building, and negotiation skills. Good facilitation, presentation, and prioritization skills. Ability to manage multiple projects. Must have strong computer skills/knowledge and statistical skills as applicable to Quality/Process Control. Knowledge of SPC, DOE, FMEA, Six Sigma and Lean Manufacturing. Individual must be self-motivated, able to achieve results with minimum supervision. Command Skills, Action Oriented, Conflict Management, Customer Focus, Timely Decision Making, Functional / Technical Skills, Presentation Skills, Problem Solving, Priority Setting, Dealing With Ambiguity, Written Communication CQE certification preferred, CQA certification preferred RELATIONSHIP WITH OTHERS/ SCOPE: This position consults with all levels of plant personnel on issues and projects as required. This position will also interact with personnel from other locations / positions within Mallinckrodt. This position interacts with personnel outside the company on a customer and supplier level. This position requires self-motivation and daily execution of tasks with limited supervision interaction. WORKING CONDITIONS: Generally normal office and meeting room conditions, but must complete some routine assignments in plant and non-air conditioned production environment. Exposure to fugitive emissions of chemicals typical for chemical operations. Position may require some travel. Must be able wear the required Personal Protective Equipment (PPE) as deemed necessary by EH&S, leadership team, corporate, or safety guidelines. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Designs, plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of pharmaceutical and/or biological products. Uses sound statistical methodology to conduct studies relating to the life cycle of the product. In development-phase projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards. Develops and/or applies statistical theories, methods, and software. Summarizes and interprets data into tabular and graphical formats amenable to principles of statistical inference and is responsible for the statistical component of reports describing studies, outcomes and methods used. Provide specifications and directions to the clinicians/statistical programmers. Supports the regulatory review and approval of the experimental therapies. May partner in trial design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data. Job Description Summary We are seeking a visionary leader to shape and drive Clinical Data Science strategy across our global clinical development portfolio. This role ensures the rigorous application of statistical principles and advanced data science methodologies to optimize clinical trial efficiency and accelerate innovation. The Executive Director will spearhead the integration of AI/ML solutions for applications in disease diagnosis, modeling, imaging, genomics, proteomics, and precision medicine. Acting as the primary data science representative to global regulatory authorities, this individual will defend strategies and influence industry standards. Strategic Leadership: Define and execute Clinical Data Science strategies for clinical studies and development plans across the portfolio. Serve as the primary spokesperson for Data Science at Health Authority meetings, leading preparation of responses and influencing regulatory perspectives. Innovation & Execution Drive adoption of cutting-edge AI/ML methodologies for disease modeling, biomarker analysis, and precision medicine. Oversee multiple large-scale, critical data science initiatives, ensuring timely, high-quality deliverables aligned with industry best practices. Risk Management & Problem Solving Evaluate analytical options, proactively identify risks, and develop novel solutions to complex challenges. Thought Leadership & External Engagement Represent the organization at technical seminars and conferences; build networks with industry experts to advance best practices. Team Leadership & Development Manage and mentor a diverse team of data scientists and people managers across geographies. Foster career growth through open dialogue, performance management, and strategic development planning. Operational Excellence Ensure GxP compliance in data science programming for clinical trials. Manage budgets, vendor relationships, and third-party deliverables to maintain quality and efficiency. Executive Communication Deliver clear, compelling communication of complex data science concepts to internal and external stakeholders with executive presence. Qualifications Ph.D. in Biostatistics or a Master's Degree in Biostatistics in combination with a Ph.D.in Bioinformatics or related computational sciences. Deep expertise in statistical methods and their application in clinical trials. Minimum 10 years of industry experience in clinical development, including Data Science and Biostatistics. Recognized thought leader in at least one data science discipline (e.g., AI/ML modeling, precision medicine). Proven experience presenting at external forums and influencing regulatory authorities. Strong people leadership experience in a Data Science setting. Prior research experience in neurology, particularly Alzheimer's disease biomarkers (plasma, CSF, imaging), strongly preferred. Eisai Salary Transparency Language: The annual base salary range for the Executive Director, Clinical Data Science is from :$283,200-$371,700Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ********************************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. The Associate Director of Global Submission Management (GSM) is responsible for leading, managing, strategizing, and overseeing the planning, preparation, coordination, and delivery of global regulatory submissions in compliance with applicable regulations and standards. This role involves providing hands-on operational support for submission activities while ensuring strategic alignment and process optimization across different regions. It also includes resource planning, budgeting, vendor management, and technical oversight to support the objectives of Global Regulatory Operations. The Associate Director will collaborate with the Heads of Submissions Management for the EU and Japan as needed and utilize "Follow-the-sun" processes to ensure submission timelines are met regardless of the region. The Associate Director, Global Submission Management (GSM, is responsible for the effective operation of Global Submission projects, ensuring the consistent application of global procedures and standards, and proactively assessing process performance for necessary optimizations. The Associate Director serves as the primary liaison between R&D functions, acting as the submission lead for designated global applications (e.g., INDs, NDAs, MAAs, supplements, amendments, and variations), to facilitate cross-functional logistics and communication that support submission planning. This role provides submission leadership by managing the operational aspects of global regulatory submissions to produce high-quality, time-sensitive deliverables in accordance with agreed-upon submission timelines. Additionally, the AD oversees the process for creating and updating the Global Regulatory Operations Submission Content Plan (GSCP) for major regulatory submission final deliverables, ensuring compliance with applicable regulatory agency regulations, guidelines, and specifications (e.g., FDA, EMA, HC, PMDA, Emerging Markets, ICH, CDISC) within defined timelines. Essential Functions: Leadership and Strategy * Provides leadership for the Global Submissions Team ensuring projects are appropriately resourced, partnering with other regional Submission Heads for additional support for resources when needed. * Provides the Regulatory Submission Management for a lead compound or submission project that has been identified as critical to Eisai's business success. * Provides management oversight for the Global Submission Management department, supporting the generation, and when necessary, the re-engineering of Eisai "Best Practices" related to global submission management and dossier development in pursuit of optimal processing performance while maintaining full compliance with Health Authority requirements and guideline. Global Collaboration * Collaborates with the EU and Japan Heads of Submission Management to optimize resource allocation and implement "follow-the-sun" workflows for timely submissions across all regions. * Foster strong cross-regional communication and collaboration to support global objectives. * Promotes a culture of performance and teamwork, with a focus on staff development in technical skills, interpersonal skills, education, and training, enhancing competency and professionalism. * Maintains visibility within the organization by regularly presenting on various GSM-related topics. This includes showcasing the achievements, ongoing projects, and developments of the GSM organization, as well as emerging trends in eCTD regulatory submissions. Additionally, cultivate positive and constructive relationships with other members of the Global Regulatory Operations (GRO) team and regulatory colleagues. * Actively participates in agency/industry events regularly, staying abreast of current developments, trends, and technologies, fostering constructive business relations with other industry peers, Health Authority representatives, and critical business partners/vendors. * Analyzes trends and evaluates the impact of changes in Health Authority requirements for e-submissions, communicating these changes to the relevant areas within Eisai and driving the necessary changes to processes and procedures. * Ensure the timely completion of all administrative tasks for this position, including but not limited to monthly reports, performance objective setting, performance reviews, and training, for self and staff. Hands-On Submission Support * Actively participates in submission planning and execution, including document compilation, publishing, and quality checks. * Provide technical oversight and troubleshooting for eCTD submissions and related systems. Operational Excellence * Ensure consistent application of GSM global procedures and standards. * Proactively monitors and assess process performance, identifying opportunities for continuous improvement. Requirements * Bachelor's degree in scientific or information technology field; advanced degree preferred * 8+ years of pharmaceutical industry regulatory experience * 5+ years of experience with submissions management, process development, standards development and compilation of electronic major submissions required * Proficient with U.S. and EU submission requirements including but not limited to Emerging Markets * Advance experience with the drug development process and eCTD regulatory submission standards * Expert understanding of Project Management concepts and techniques * Ability to apply SOPs regulations pertaining to electronic submissions * Ability to lead cross-functional team, establish effective relationships with team members and work well in a cross functional team environment * Advance experience creating timelines for the development and submission of drug filings to regulatory health authorities * Excellent organizational skills to support multi-task and manage submission timelines in a fast-paced environment with changing priorities * Well-organized with the ability to multi-task and work with minimal supervision * Ability to manage change to support organization's effectiveness by implementing change * Effectively communicates written and verbal communication skills * Demonstrates strong analytical, problem solving and critical thinking skills with the ability to analyze problems, identify alternative solutions and implement recommendations for resolution. * Certification is a plus (such as Regulatory Affairs Professional Society (RAPS) Technical Skills Required * Advance working knowledge of global regulatory submission standards, publishing software, software validation concepts, and regulatory publishing best practices * Proficiency in eCTD publishing tools (e.g., Lorenz docu Bridge, Extedo eCTDmanager, or equivalent). * Strong understanding of ICH guidelines, regional regulatory requirements, and data standards (e.g., CDISC). * Extensive experience with Regulatory Information Management (RIM) systems and Document Management Systems (e.g., Veeva Vault, SharePoint, Documentum) * PowerPoint, SharePoint, XML, Adobe Acrobat, ISI Toolbox and eData transfer systems * Ability to troubleshoot technical issues related to electronic submissions and publishing. We are open to remote-based, but the preference for this role is a hybrid work arrangement in Nutley, NJ with 3 days a week in office every week (Tuesday, Wednesday. Thursday). Eisai Salary Transparency Language: The annual base salary range for the Associate Director, Global Submission Management is from :$159,000-$208,700 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ********************************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation

Why Us? At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. Summary Prepare and execute validation projects for all aspects of pharmaceutical API manufacturing to include Equipment Validation, Equipment Requalification, Process Validation, Packaging Validation, Cleaning Validation, Computer System Validation, and Data Integrity Analysis. Coordinates with cross-functional resources in the execution of cleaning validation projects and ensures compliance with FDA, EU, JP cGMP and any other appropriate regulations. Supports manufacturing, packaging and quality control with new equipment validation, process improvements, review and approval of change control documentation, review of exceptions related to deviations from cleaning processes and provides technical support as required. Ensures product quality through robust testing and process monitoring including use of statistical process control techniques, Six Sigma tools, understanding of current compliance and technology trends, and application of related pharmaceutical experience. Job Description Primary Job Functions: Assists with multiple cross-functional projects from development through release to production. Projects include new facilities startup, manufacturing equipment and packaging line FATs and qualifications. Manage manufacturing and laboratory equipment requalification program. Assist in the management, support and continued development of the Cleaning Validation Program. Generate protocols, equipment swab diagrams, product risk assessments and general technical reports related to cleaning validation. Independently execute activities in support of the Validation Department cleaning validation program priorities with minimal guidance from the department manager. Establish and/or extend clean and soiled hold times. Analyzes data, utilizing appropriate statistical methods, generated by studies performed by the Validation Department to determine process capabilities. Support any deviations encountered associated with validation activities. Secondary Job Functions: Execute validations as needed, including assisting in product sampling, auditing and technical review functions as defined in study protocols. Review and approve change control documentation to assure all validation requirements are detailed in the Action Items. Ensures compliance with data integrity requirements. Protocols & Reports Meet Organizational Requirements Develops protocols using engineering experience and statistical process controls. Prepares and maintains validation records in accordance with department procedures to ensure compliance with current standards. Evaluates effectiveness of SOPs, identifies changes that would enhance the process, and ensures alignment with corporate procedures. Ensures compliance with FDA regulations and assists in audits. Current with Industry Trends through Continuous Improvement Stays current with regulatory requirements and creates remediation plans. Drives continuous improvement to stay aligned with industry trends. Works cross-functionally with team, other departments, and corporate validation to support improvements. Identifies and implements ways to streamline and improve efficiency while maintaining process effectiveness. Willing to challenge current practices. Experienced with using tools like an FMEA to use a risk based approach to determine and prioritize actions. Minimum Requirements Education: Bachelor Degree in engineering discipline or technical field related to pharmaceutical manufacturing is preferred or Associates Degree with equivalent combination of education, experience, and competencies may be considered. Experience: Minimum of 5-10 years of previous validation experience in pharmaceutical manufacturing, with an emphasis on process and cleaning validation. Preferred Skills/Competencies: Extensive experience with process and cleaning validation. Strong technical and mathematical aptitude. Training or certifications in regulatory and cGMP requirements is desired. Knowledge of FDA regulated drug validation requirements including knowledge of cGMP regulations in parts 201 and 2011, and FDA 21 CFR Part 11. Other Skills/Competencies: Strong computer literacy-MS office products, statistical analysis (Minitab) and database usage. Knowledge of statistical process controls is also required for equipment qualifications. Strong communication skills. Attention to Detail: Is thorough and precise in accomplishing a task through concern for all the areas involved, no matter how small; monitors and checks work or information and plans and organizes time and resources efficiently; double-checks the accuracy of information and work product to provide accurate and consistent work; provides information on a timely basis and in a usable form to others who need to act on it; remains aware and takes care of details that are easy to overlook or dismiss as insignificant; compares observations of finished work to what is expected to find inconsistencies. Project Management: Manages projects according to a standard process by using a systems development lifecycle; effectively directs and integrates all aspects of a project or program, ensuring that work progresses toward achieving goals and objectives; achieves expected results through the successful and timely completion of activities; at the end of a project, with project team, takes time to determine what was learned that can be applied to future projects. Analytical: Uses a systematic approach in solving problems through analysis of problem and evaluation of alternate solutions; uses logic, mathematics, or other problem-solving tools in data analysis or in generating solutions; logically and thoughtfully sorts through ambiguity and alternatives with rigor and discipline that crystallizes ideas for action. RELATIONSHIP WITH OTHERS/ SCOPE: This position consults with all levels of plant personnel on issues and projects as required. This position will also interact with personnel from other locations / positions within Mallinckrodt. This position interacts with personnel outside the company on a customer and supplier level. This position requires self-motivation and daily execution of tasks with limited supervision interaction. WORKING CONDITIONS: Generally normal office and meeting room conditions, but must complete some routine assignments in plant and non-air conditioned production environment. Exposure to fugitive emissions of chemicals typical for chemical operations. Position may require some travel. Must be able wear the required Personal Protective Equipment (PPE) as deemed necessary by EH&S, leadership team, corporate, or safety guidelines. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary SUMMARY OF POSITION: The Maintenance I/E Technician performs a variety of electrical and instrumentation duties involving the maintenance of plant facilities. S/he will be responsible for calibrating, installing, maintaining, repairing, and inspecting plant monitoring devices on a wide variety of complex digital, analog, programmable, and other auxiliary equipment. Job Description ESSENTIAL FUNCTIONS: Installs, troubleshoots, repairs, and calibrates low voltage AC/DC electrical and instrumentation controls as well as 3-phase 480-volt power circuits. Interfaces with OEM's and vendors as necessary. Requisitions equipment as needed. Accurately completes all work performed according to standard operating procedures (SOPs) and work instructions, including proper documentation. Completes work orders using CMMS (Maximo) system. Performs repairs and modifications as directed by maintenance supervisor, or other plant management. Supports and participates in training programs. Keeps the maintenance supervisor abreast of job status. Supports site safety programs. Supports/leads failure analysis process by discussing the causes of equipment failure with the maintenance supervisor, or the maintenance engineer. Accurately completes all required paperwork, including but not limited to timesheets, “found as-left” forms, calibration reports (ICIR), and PM checklists. Responsible for good housekeeping in the shop and at the job site. Must be able to wear the required Personal Protective Equipment (PPE), full face respirator, hard hats, safety glasses, ear plugs, goggles, boots, steel -toe shoes, gloves, chemical resistant aprons and suits, and other personal protective equipment deemed necessary by EHS, leadership team, corporate, or safety guidelines for each job task. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Other duties as assigned with or without accommodations. Supports the PM/PdM program and calibration program by ensuring a high quality of workmanship. Accurately enters all required information on work orders. Assists the maintenance supervisor and maintenance engineers, or others as needed with equipment installation, maintenance, repair techniques, and with identifying opportunities for improving equipment reliability. Shows emphasis on the design, installation, commissioning, maintenance, and use of mechanical equipment throughout the facility. Recognizes problem independently and troubleshoots malfunctioning equipment without direct supervision. MINIMUM REQUIREMENTS: Education: High School diploma, GED, or equivalent. Associate or Technical degree in a mechanical field preferred. Experience: 1 - 3 years I/E experience in a pharmaceutical manufacturing operation. Preferred Skills/Qualifications: Skills/Competencies: Other Skills: Work as an industrial I/E mechanic, PLC skills. Must have a working knowledge of the tools and test equipment used for testing, calibrating, repairing, and maintain production instruments and controls. Must be able to read and comprehend blueprints, electrical schematics, and engineering specifications. Must be able to perform shop math. Must be able to understand electricity, respect, and follow safety guidelines. Must be able to read and follow written instruction. Should be familiar with National Electrical Code, NFPA 70E, calibration standards, and cGMP. Experience working with voltages up to 480. Experience with CMMS, such as MP2 or Maximo. Learning on the Fly, Problem Solving, Interpersonal Savvy RELATIONSHIP WITH OTHERS/ SCOPE: Reports to Maintenance Supervisor. Utilizes a variety of test instruments, hand tools, supplies, and other shop equipment on a daily basis. On occasion, it may be required to take tools to the work area in the plant. No direct responsibility exists for the works of others, although adherence to the team concept requires mutual assistance in some jobs. Indirectly responsible for amount and quality of product through the maintenance and repair of production equipment. A thorough understanding of cGMP is critical. Significant responsibility for the safety of others, improperly repaired equipment could possibly result in safety hazards to plant personnel. Understands the misuse of processing equipment could result in serious injuries to self and others due to the potentially dangerous nature of the equipment and the chemicals being processed. WORKING CONDITIONS: I/E Technicians are required to work in all areas of the plant site, both inside and outside. There may be exposure to warm areas, dirt, oil, grease, chemicals/chemical fumes, and noise. Injuries could result from spills or leaks or corrosive, flammable, and toxic material, all which are normally handled in the plant. Dangers, such as sharp edges, pinch points, chemical and temperature burns, lifting, and electricity are often present. Personal protective equipment required to be worn often. Routinely lifts and carries objects of 50 pounds or less in weight. Must be able to go up and down several flights of steps on occasion. May be required to exert effort to pull control valves, loosen bolts, or move controls and instrumentations. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice (************************************** and Terms of Use (********************************************* . I further attest that all information I submit in my employment application is true to the best of my knowledge. **Job Description** **About the role:** The Rare Disease Business Manager (RDBM) is responsible for driving sales and territory growth through effective execution of sales strategies and tactics in a rare neurological sleep disorder, called narcolepsy type 1. This role involves collaboration with their Regional Business Leader and other cross-functional, customer-facing teams to ensure healthcare providers (HCPs) are well educated and that appropriate patients have access to a new therapeutic option, once approved by federal agencies. Reporting into a Regional Business Leader, the RDBM will support a new product introduction in a new therapeutic area for Takeda. Strong execution, insights gathering, and building our Company's reputation will be critical to our success. The role will establish and build impactful relationships with targeted HCPs and accounts within their geographic territory. Following regulatory approval, the Rare Disease Business Manager will play a key role in generating demand for a new therapeutic option by focusing on educating and informing healthcare professionals by providing clinical information and in-depth knowledge of the product, the orexin system, and narcolepsy type 1. **How you will contribute:** + Results Focused: Demonstrates a strong sense of urgency to drive results and achieve strong performance by delivering a high level of sales effort will be necessary for a successful rare disease product introduction. + Clinical Expertise: Possesses and delivers exceptional disease state, product knowledge, and selling skills in working with HCPs to support product education and drive demand. + Sales Strategy and Execution: Following approval, drive sales by implementing sales and marketing plans, leveraging strong selling skills utilizing approved, on-label materials to achieve monthly, quarterly, and annual sales goals. Execute brand strategies and manage all business-related activities within the assigned geographic territory, focusing on achieving sales goals and advancing the diagnosis and treatment of NT1. + Specialty Customer Engagement: Builds strong relationships with, and educates healthcare professionals (HCPs), including sleep specialists, neurologists, pulmonologists, sleep centers and associated clinic staff, on disease state and approved Takeda orexin therapies. + Strategic Analysis and Territory Planning: Strategically analyze local, regional, and national business trends and apply data to assess business opportunities and strategic priorities. Leverage market insights to appropriately tailor regional and local business strategies to market trends and customer needs. + Communication Skills: Strong communication skills will be critical in discussions with specialty HCPs and accounts for a rare disease therapy. Utilize CRM system to document account profiles, develop pre-call plans and record post-call activities. + Financial Responsibility: Manage a territory budget in a manner that is consistent with all Takeda compliance policies. + Cross-Functional Collaboration: Partner with internal teams such as Patient Access, Market Access, Marketing to align on strategies and tactics that support customer and business outcomes. Collaborate with Sales and Marketing leadership to provide feedback that further supports sales tactics and performance. Foster a collaborative culture of accountability and engagement with cross-functional team members to enhance performance and impact. + Compliance and Ethical Standards: Exemplify Takeda's patient-first values and commitment to upholding high standards of customer satisfaction. Adhere strictly to all Takeda compliance policies, guidelines, training and relevant laws and regulations. Demonstrate leadership and integrity by seeking clarification when uncertain on compliance matters. **Minimum Qualifications:** **Required:** + Bachelor's degree - BS/BA. + 3+ years of successful selling experience in pharmaceutical, biotech or medical device and/or relevant clinical or industry experience.; OR 2+years of successful selling experience at Takeda. + Excellent verbal and written communication skills. + Proven ability to navigate complex selling environment and influence across various decision makers in key accounts. + Strong business acumen and strategic planning skills to identify and execute on selling opportunities. + Demonstrated territory planning, strategic account management and prioritization skills. Ability to interpret analytical data to create effective sales strategies. + Strong collaborative skills and ability to work within a matrix of cross functional partners on behalf of the customers served. + Understanding of payer access and reimbursement at territory, regional, and state levels. + Adaptability to changing market conditions and customer needs. + Demonstrated learning agility with ability to successfully develop and compliantly apply clinical expertise and selling skills. + Must reside within the territory or within close proximity to assigned geography. **Preferred** + 5+ years of pharmaceutical sales experience, preferably in rare disease or sleep disorders + Sales experience with pharmaceutical or biologic products requiring coordination with patient access and market access teams. + Relevant clinical or industry experience. + Consultative / needs-based selling skills. + Experience working in a highly regulated marketplace. + Adept at leveraging emerging technologies, digital tools, and openness to AI-enabled processes. **Licenses/Certifications** Valid Driver's License **Travel Requirements** + Ability to drive and/or fly to accounts and occasional business meetings + Some overnight travel of up to 25-50% may be required depending on geographic assignment **TRAINING REQUIREMENTS:** + This position and continued employment is contingent upon the employee successfully passing mandatory product training which includes written and oral examinations. + External Takeda Hires Only: During that training period, the employee will be classified as a non-exempt employee and will be eligible for overtime during the training period only in accordance with applicable federal and/or state law but the employee will not be eligible for any Takeda related sales incentive programs and/or other production based bonuses. The training period will consist of live instruction, independent study, role play, and other training related activities which should take no more than 8 hours per day and 40 hours total in a workweek. + After successful passage of the mandatory product training examinations, the employee will be transitioned to exempt status and will no longer be eligible for overtime. They will then be paid on a bi-weekly basis and eligible to participate in various Takeda related sales incentive programs and/or contests. **Takeda Compensation and Benefits Summary** We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. **For Location:** North Carolina - Virtual **U.S. Hourly Wage Range:** $66.11 - $90.91 The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. **EEO Statement** _Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._ **Locations** North Carolina - Virtual **Worker Type** Employee **Worker Sub-Type** Regular **Time Type** Full time **Job Exempt** No \#LI-Remote

**Why Us?** At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. ** Summary** The Maintenance Mechanic performs a variety of mechanical tasks to install, maintain, repair, and troubleshoot plant equipment and site facilities. **Job Description** **ESSENTIAL FUNCTIONS** **:** + Installs, troubleshoots, and repairs process equipment, which includes hydraulic, pneumatic and mechanical systems to include pumps, gear reducers, fans, centrifuges, boilers, compressors, vacuum systems and a wide variety of facility equipment in a GMP environment. + Interfaces with OEM's and vendors as necessary. Requisitions equipment as needed. + Accurately completes all work performed according to standard operating procedures (SOPs) and work instructions (WIs), including proper documentation. Completes work orders using CMMS (Maximo) system. + Performs repairs and modifications as directed by Maintenance Supervisors and Plant Management. + Supports and participates in training programs. + Keeps the Maintenance Supervisors abreast of job status. + Supports site safety programs. + Supports/leads failure analysis process by discussing the causes of equipment failure with maintenance technicians, maintenance supervisors or the maintenance engineer. + Responsible for good housekeeping in the shop and at the job site. + Must be able to wear the required Personal Protective Equipment (PPE), full face respirator, hard hats, safety glasses, ear plugs, goggles, boots, steel -toe shoes, gloves, chemical resistant aprons and suits, and other personal protective equipment deemed necessary by EHS, leadership team, corporate or safety guidelines for each job task. **DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:** + Other duties as assigned with or without accommodations. + Supports the PM/PdM program by ensuring a high quality of workmanship. + Accurately enters all required information on work orders. + Assists Maintenance Supervisors and Maintenance Engineers and others with equipment installation, repair techniques and identifying opportunities for improving equipment reliability. Show emphasis on the design, installation, commissioning, maintenance and use of mechanical equipment throughout the facility. + Recognizes problems independently and troubleshoots malfunctioning equipment without direct supervision. **MINIMUM REQUIREMENTS** **:** _Education:_ High School diploma, GED or equivalent. Associate or Technical degree in a mechanical field preferred. _Experience:_ 1 - 3 years mechanical experience in a pharmaceutical manufacturing operation. _Preferred Skills/Qualifications:_ _Skills/Competencies:_ _Other Skills:_ Welding skills. Shaft Alignment Precision Maintenance Lubrication Mechanical Seals Pumps- Multiple types (Centrifugal, positive displacement, etc) Gearboxes Torque and its application Must have knowledge of basic hand tools. Must be able to perform basic math. Must be able to read measuring tape, calipers and blueprints. Must be able to read and follow written instruction. Experience with a CMMS such as MP2 or Maximo. Learning on the Fly, Problem Solving, Interpersonal Savvy **RELATIONSHIP WITH OTHERS/ SCOPE:** + Reports to the Maintenance Supervisor. + Utilizes a variety of test instruments, hand tools, supplies and other shop equipment on a daily basis. + No direct responsibility exists for the works of others, although adherence to the team concept requires mutual assistance in some jobs. + Indirectly responsible for amount and quality of product through the maintenance and repair of production equipment. A thorough understanding of cGMP is critical. + Understands the misuse of processing equipment could result in serious injuries to self and others due to the potentially dangerous nature of the equipment and the chemicals being processed. **WORKING CONDITIONS:** + Technicians are required to work in all areas of the plant site, both inside and outside. There may be exposure to warm areas, dirt, oil, grease, chemicals/chemical fumes and noise. + Injuries could result from spills or leaks or corrosive, flammable and toxic material, all which are normally handled in the plant. + Dangers such as sharp edges, pinch points, chemical and temperature burns, lifting and electricity are often present. Personal protective equipment required to be worn often. + Routinely lifts and carries objects of 50 pounds or less in weight. Must be able to go up and down several flights of steps on occasion. May be required to exert effort to pull control valves, loosen bolts or move controls and instrumentations. + May be required to wear a full-face respirator contingent upon required job duties. **DISCLAIMER** **:** The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. **EEO Statement:** We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Why Us? We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. Summary Summary SUMMARY OF POSITION: The Production Engineer will function as a part of the APAP Operations Team. The Production Engineer will apply technical skills to manage day-to-day production, optimize plant operation, resolve operational issues, and investigate process deviations. The Production Engineer will provide technical assistance to the APAP manufacturing employees to ensure that production targets are met while complying with all applicable Safety and Quality rules and regulations Job Description ESSENTIAL FUNCTIONS: Studies process and equipment to identify problems and opportunities. Provides technical guidance and instruction to APAP Operations Team regarding troubleshooting and debottlenecking efforts. Ensures that all processes operate within defined and validated limits. Conducts training for APAP Operations Team on new equipment and process changes. Represents the APAP Operations Team in developing and implementing capital projects. Activities include project scoping, operating requirements, process controls, process tolerances, alarm rationalization, and validation. Prepares periodic reports that summarize production rate, yield, rework status, quality condition and that summarize any special projects or problems that have been encountered. Identifies and implements changes to reduce product cost by increasing production rate, improving yield, reducing downtime, improving equipment efficiency, etc. Participates in periodic process audits with management personnel with respect to safety, environmental, quality, production, and cost. Generates, reviews, and updates documentation for managing the process, including operating reports, batch records, P&IDs, etc. Reviews operating reports and batch records for accuracy and improvements. Participates in customer and regulatory audits. Investigates process deviations, inquiries, complaints and equipment loss incidents and identifies corrective and preventative actions where needed. Coordinates implementation of corrective measures. Actively supports site continuous improvement process and serves on teams as needed to improve the workplace and increase efficiency and productivity. Other duties as assigned with or without accommodation. MINIMUM REQUIREMENTS: Education: Must have a B.S. in Chemical or Mechanical Engineering Experience: Must possess knowledge of chemical and chemical engineering principles in order to solve production, quality and throughput problems. 1-5 years of experience in chemical or bulk pharmaceutical (API) manufacturing operations Preferred Skills/Qualifications: Other Skills: Competencies: Understanding of GMPs (ICH Q7) and process validation Understanding of Six Sigma and Lean Manufacturing tools and concepts Experience in root cause analysis Experience with change control / management of change Demonstrated technical and leadership skills including oral/written communications, conflict resolution, decision making and sufficient financial acumen to interpret cost analyses and other reports Ability to plan and execute tasks on multiple projects simultaneously Must strive for continuous improvements in all work activities Self-motivated, Action-oriented, Technical Skills, Problem Solving, Informing, Organizing RELATIONSHIP WITH OTHERS/ SCOPE: The Production Engineer will report to the APAP Focus Factory Manager The Production Engineer will work closely with the other APAP Sr. Production Engineers, Supervisors and Sr. Day Operator to coordinate tasks Frequent interactions with the following functions will be required: APAP production operators QA and QC Maintenance and Engineering EHS Periodic interaction/communication with all site departments and corporate groups May work with outside engineering design firms, manufacturer's representatives, vendors, and construction contractors WORKING CONDITIONS: Works in an office environment, but will spend significant time in a multi-story bulk pharmaceutical (API) manufacturing plant that is partly outdoors May be exposed to fugitive emissions of chemicals typical of chemical operations Must be able to climb stairs and ladders for equipment installation review, monitoring and troubleshooting. Must be willing and able to wear PPE including hard-hat, steel-toed shoes, safety glasses, earplugs, fire-resistant clothing and any other devices or equipment that may be required Position is required to be periodically available for on-call nights/weekends DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

We are looking for undergraduate juniors and seniors majoring in Chemical Engineering, Chemistry, Biochemistry or a related discipline for a 12-week internship role in Durham, NC from May 18th to August 7th. * Support the design/development of innovative Process Analytical Technologies (PAT) and PoC study execution for both R&D and GMP spray drying processes. * Assist in digital continuous improvement initiatives by strengthening in-silico process development tools. This includes developing robust integrations between the process data historian, data visualization dashboards, and predictive process models. * Develop Lean SWI by establishing clear, detailed standard work instructions for critical manufacturing unit operations - under guidance and collaboration with Ops and Engineering team members. * Support process development activities as needed. Position Requirements: * Undergraduate juniors and seniors majoring in Chemical Engineering, Chemistry, Biochemistry or a related discipline. Candidates must have an expected graduation date after August 2026. * Process Engineering Fundamentals: Understanding of mass/energy balances, thermodynamics, and fluid dynamics required. * Data Analytics & Visualization: Experience with tools like Python, MATLAB, or JMP for data analysis and dashboard development required. * Process Modeling: Familiarity with first-principles modeling and simulation software (e.g., Aspen Plus, gPROMS) required. * Digital Integration: Knowledge of data historians (e.g., OSIsoft PI) and linking process data to analytical models required. * Pharmaceutical Manufacturing Exposure: Awareness of GMP principles and R&D workflows preferred. * Problem-Solving & Continuous Improvement: Ability to apply structured approaches to optimize processes required. * Communication & Collaboration: Comfortable working in cross-functional teams and presenting technical findings required. * Ability to use and/or develop AI tools preferred. * Ability to report onsite to Durham, NC 5 days per week. This role will not provide relocation assistance. * US Work Authorization is required at time of application. * This role will not be providing CPT support. * Compensation range: $37 - $39 hourly. Date Posted 09-Jan-2026 Closing Date 29-Jan-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.