Sanofi US jobs in Raleigh, NC

**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: This position is responsible for operating large scale manufacturing equipment to produce bulk organic chemicals 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 wearing appropriate personnel protection equipment (PPE), understanding and following all applicable standard operating procedures, work instructions, and standard work practices applicable to job responsibilities + Operates and monitors dryers, mills, sifters, and other miscellaneous equipment through manual operations, panel boards, indicators, PLC displays, and DCS screens following applicable batch records, procedures and good documentation practices + Packages, weighs, samples, and labels finished and intermediate products following applicable procedures and good manufacturing practices + Maintains detailed operating reports and logs, 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 + Delivers samples to laboratory and retrieves operating supplies from storeroom + Cleans and maintains work area, process equipment, tools and safety supplies according to regulatory and Company standards and operating procedures. + Other duties as assigned by Management **DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:** + Monitors environmental and safety devices (scrubbers, ruptured discs, etc.) to insure that the equipment is functioning properly. + Performs Lock Out/Tag Out (LOTO) independently. + Operates fork lifts, hoists, and other material handling devices to physically move bulk raw materials, WIP, and packaged goods to and from pick-up points + Participate in various employee involvement teams and committees, such as Area/Site Safety Teams, kaizen events, Hazmat and/or Cost Savings Teams, to improve the workplace, increase efficiency, and improve productivity **MINIMUM REQUIREMENTS** **:** _Education:_ High School Diploma, GED, or equivalent required. Associate or Technical degree preferred. _Experience:_ Previous GMP/ISO manufacturing experience preferred _Skills/Qualifications:_ _Skills/Competencies:_ _Other Skills:_ Must be able to read and follow detailed instructions and procedures, and effectively communicate in both verbal and written formats. Must be able to perform basic math. Must have a working knowledge of chemical processing equipment and associated safety requirements. Possess sound decision making skills. Action Oriented, Informing, Computer Skills (MS Office and E-mail), Problem Solving, and Teams Must work in a team environment to cover work stations during breaks and lunches Must be able to wear the required Personal Protective Equipment (PPE) required for the job or task. Sound decision making skills. Action Oriented, Informing, Computer Skills (MS Office and E-mail), Problem Solving, and Teams **RELATIONSHIP WITH OTHERS/ SCOPE:** + Performs diversified duties following standard procedures and under the direction of a production supervisor or lead operator. Requires a high level of safety awareness and ability to determine when equipment is not performing to standards or expectations. + Responsible for proper operation of processing equipment to ensure optimum production of high quality products. Mistakes and errors normally result in unacceptable product and or mechanical equipment damage. As a result, impacts our product status in the market place. + 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. + No direct responsibility for the work of others; however, the team approach is emphasized in order to cover work stations during breaks and lunches. Furthermore, the "buddy system" for training new operators creates additional responsibility. **WORKING CONDITIONS:** + The plants open-air construction exposes operators to the normal year-round outside climate. Some relief from the elements is available in the control rooms and break area. + Dirty conditions and chemical fumes are occasionally present in the work areas. + Must handle average to heavy weight materials by hand. Material handling devices (e.g., hand truck, for 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 climb stairs and evacuation ladders, rolling drums, lifting and pouring bags of raw materials, driving forklifts, climbing and entering reaction vessels and perform first aid. + Injuries could result from spills or leaks of corrosive flammable, and toxic material, all of which are normally handled in the plant + Must be able to work rotating 12 hours/day shift and 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. 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.

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe. Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we're taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention. The Role: The Global Study Associate is a member of the global study team supporting delivery of clinical studies within BioPharmaceuticals Clinical Operations, Study Management to time, cost and quality. The GSA supports delivery of global clinical studies from study set-up through maintenance, close-out and study archiving. The GSA supports the Global Study Director (GSD), Global Study Associate Director (GSAD) and/or Global Study Manager (GSM) with coordinating activities, ensuring quality and consistency. The GSA supports with administration & systems and with other delegated aspects of clinical study execution in accordance with applicable clinical trial regulations (ex. ICH-GCP), AstraZeneca (AZ) Standard Operating Procedures (SOPs), AZ policies & best practices and AZ values & behaviours. Typical Accountabilities: Support GS(A) D and GSMs by completing delegated study work. May work across many different studies and delivery models concurrently. Initiate and lead the set-up of the electronic Trial Master File (eTMF). Maintain and close the eTMF to ensure compliance to International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) and AZ SOPs. Provide oversight for non-complex, non-critical path vendors, ensuring compliance with study requirements and established processes. Interact/collaborate with internal staff and external stakeholders in collection of regulatory and other essential documents. Contribute to electronic applications/submissions in regulatory information management system by creating and managing clinical regulatory documents according to the requested technical standards and supporting effective publishing and delivery to regulatory authorities. Proactively plan and collate the administrative appendices for the CSR. Initiate, maintain and/or support the creation of study documents, ensuring template and version compliance per study specific requirements. Set-up, populate and accurately maintain information in AstraZeneca tracking and communication tools and support team members in the usage of these tools. Support the set-up, maintenance and close-out of Clinical Trial Transparency (CTT) activity in PharmaCM, coordinating with relevant stakeholders to fulfil AstraZeneca compliance and meet the regulatory authority needs. Support the GS(A) D with tracking, reconciliation and follow-up of the study budget/payments in relevant systems, including the creation and maintenance of purchase orders, running invoice and payment reports. Contribute to application, coordination, supply and tracking of study materials and equipment. Contribute to collection of study supplies, if required, at the study close-out. Coordinate and provide oversight of administrative tasks and logistical support throughout the conduct of the study, audits and regulatory inspections, according to company policies and SOPs. Lead the coordination and contribute to the preparation of internal and external meetings e.g., study team meetings, committee meetings, monitor meetings, Investigator meetings and virtual meetings. Liaise with internal and external participants and/or vendors. Prepare, contribute and distribute presentation material for meetings, newsletters and websites. Work on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their manager. Other duties as assigned and within scope of role. Essential Experience: Bachelor level education, with at least 2 years' experience in in medical or biological sciences or discipline associated with clinical research preferred Proven study admin/assistant or relevant experience on a study level with experience in clinical study lifecycle Proven organizational and analytical skills Previous administrative training/experience Computer proficiency in day-to-day tasks Develop working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines Excellent verbal and written communication in English Demonstrate ability to work independently, as well as in a team environment Ability to prepare presentation materials Demonstrate professionalism and mutual respect Willingness and ability to train others on study administration procedures Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high- volume environment with shifting priorities Are you interested in working at AZ, apply today! AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing *********************************. #LI-Hybrid Date Posted 15-Dec-2025 Closing Date 01-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.

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Daiichi Sankyo, Inc. (DSI) is currently seeking a Medical Science Liaison (MSL) to join the Field Medical Affairs Team. The MSL develops ongoing professional relationships with national and regional healthcare opinion leaders and other healthcare professionals to provide medical and scientific support for Daiichi Sankyo, Inc. (DSI) initiatives in selected therapeutic areas. The MSL develops skills and competencies to educate healthcare professionals, DSI internal stakeholders (e.g., Medical, Marketing, and Sales), and decision makers in healthcare systems regarding therapeutic areas and related products developed and commercialized by DSI. This is a US Medical Affairs, Field based role. This territory currently covers the following states: OH, WV, VA, NC, SC, KY, TN. Responsibilities: Builds and maintains professional relationships with healthcare professionals (HCPs) by developing the skills and with guidance, implementing the following: Presenting disease state and Daiichi Sankyo product specific data to HCPs Responding to unsolicited requests for medical information Identifying and appropriately facilitating engagement of qualified 1) investigators and study committee members for DSI clinical research programs, 2) investigator-initiated research study proposals, 3) speakers for DSI Brand Speaker programs, 4) advisors for DSI scientific, clinical and marketing advisory boards Gathering customer insights regarding DSI and competitor products to help inform medical and commercial decision-making Enhanced professional expertise through attendance of select scientific meetings and professional conferences for the purpose of continuing education and scientific exchange with key opinion leaders Develops positive working relationships with local and regional internal stakeholders to enhance DSI HCP relationships Develops the ability to apply the appropriate methods to implement the FMA department strategy within his/her geography in alignment with Medical and Brand strategies Completes administrative duties, including monthly expense reporting and field activity reporting Represents the Medical Science Liaison function by participating in DSI meetings, functions, events Additional duties and responsibilities are based on position level/title, and may include but are not limited to: Provides innovation in enhancing and developing professional relationships with national and regional healthcare opinion leaders and HCPs to provide medical and scientific support for DSI initiatives. Ability to anticipate trends and capitalize on opportunities Lead special projects/initiatives. Assist in the development of team members Represent FMA leadership at DSI meetings, functions and events Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university): PharmD, MD, PhD, NP or PA in a health sciences-related field or an equivalent combination of education and experience preferred Experience Qualifications: MSL/Sr. MSL 1 or More Years' experience, including medical & scientific affairs, clinical practice, research, academic or US-managed markets preferred Previous experience in Oncology, clinical research and medical education preferred Principal MSL/Associate Director MSL 5 or More Years' experience including medical & scientific affairs, clinical practice, research, academic or US managed markets preferred Previous experience in Oncology, clinical research and medical education preferred Additional Qualifications: Must have a valid driver's license with a driving record that meets company requirements Ability to travel up to 60% Compensation and seniority level/title based on experience and qualifications. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $150,800.00 - $226,200.00 Download Our Benefits Summary PDF

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.

Make your mark for patients We are looking for a Program Patient Safety Lead who is passionate, agile, and detail-oriented to strengthen our Early Clinical Development Benefit Risk and Medical Safety Unit team. This role can be based in one of our hubs in Braine l'Alleud, Belgium (preferred); Slough, UK; or Raleigh, US. About the role The Candidate Benefit Risk Lead is accountable for the strategic planning, communication, and delivery of benefit-risk assessments and risk management strategy (Benefit-risk assessment plan; BRAP) for assigned clinical-stage candidates. This includes identifying emerging safety concerns, evaluating benefit-risk outcomes, and developing effective risk management strategies. Who you'll work with You will work transversally with multiple UCB stakeholders (Clinical Development, Quantitative Clinical Pharmacology, Regulatory, Statistics and Non-clinical Safety amongst others) and patients to drive and implement program safety strategies. You'll lead the cross-functional Benefit Risk Team (BRT), empowering and inspiring team members to take ownership of their responsibilities and use data-driven insights to inform decisions. What you'll do Drive the program-specific safety strategy and ensure high-quality BRAP outputs with clarity, transparency, and key messaging. Implement safety monitoring and risk management strategies in collaboration with cross-functional teams. Communicate insights to support decision-making at internal governance bodies (eg. EDM, PPC, BRB). Analyze and interpret safety data (clinical, regulatory, legal, product quality) to identify potential new risks. Author and review documents in accordance with global clinical development strategy and regulatory submission requirements. Apply innovative approaches and technologies for data collection, documentation, and evidence generation. Make ethical decisions aligned with UCB's values, prioritizing patient safety and regulatory compliance. Interested? We're looking for: MD preferred , PhD, PharmD or equivalent with relevant experience Significant experience in early clinical development (first in human to proof of concept) and risk management; preferably in industry environment. Experience in Phase 1 Trials and/or Gene Therapy is highly preferred. Strong knowledge of Good Clinical Practice and international drug safety regulations. Demonstrated leadership in complex, dynamic environments with short timelines and ambiguity. Cross-functional collaboration skills to ensure credible communication with the external medical and scientific community and for internal communication. Excellent English communication skills-verbal, written, and presentation skills Proficient and positive attitude toward using digital tools *This position's reasonably anticipated base salary range is $184,000- $241,500 annually. The actual salary offered will take into account internal equity and may also vary depending on the candidate's geographic region, job-related knowledge, skills and experience, among other Are you ready to ‘go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you! About us UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science. Why work with us? At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We ‘go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential. UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

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 12 Hour Rotating Shift (7am - 7pm & 7pm -7am) 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. 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.

Job Title: Director, Technology Alliance Management (Alliance Lead) Introduction to the role: Be part of a dedicated Research & Development team. Fueled by our commitment to help more patients, strengthen our pipeline and grow our area. This is the place to go beyond discovery - we think holistically about patients and are always learning from those living with diseases. The Alliance Management (AM) group sits within BioPharma Clinical Operations and is accountable for setting the sourcing strategy across R&D and managing adherence to it. They ensure our suppliers deliver to the needs of the organizations and develop strong, beneficial partnerships with key suppliers. About the role: The role of the Alliance Management Director is to act as the Alliance Lead for one or more supplier(s). They will be responsible for ensuring the supplier(s) are meeting the operational needs of the customers; ensuring alliance effectiveness, appropriate communications, ensuring that selected partners deliver to contract; and that strong relationships with the external suppliers are created and maintained. This role will support and lead Patient Recruitment and Retention. Accountabilities: Supplier / Model Governance Accountable for the alliance management of one or more supplier(s) within or across service line(s) Proactively identifies and manages risks at the supplier/model/service line level Serves as point of contact for issue escalation to AM for their assigned supplier (s), and key in ensuring solutions are identified in collaboration with the business stakeholders. Facilitates resolution of any operational issues that impact delivery Leads operational governance of the supplier(s)/ service line(s) In collaboration with the AM Group Lead, contributes to executive level governance meetings; and contributes to or leads model level governance and supplier council forums, as required Acts as audit Sponsor and/or audit co-ordinator for AZ led supplier audits as applicable Supplier / Model Quality and Performance With the AM Group Lead ensures definition of appropriate Metrics and SLAs for the supplier within the MSA Monitors quality and performance of service deliverables in alignment with the MSA Ensures that selected suppliers deliver to contract and that strong relationships with the external suppliers and internal customers are created and maintained Ensures effective visibility of supplier performance to relevant stakeholders Ensures ongoing assessment and integration of Lessons Learned for suppliers / models/service lines Seeks opportunities to drive efficiencies and continuous improvement within supplier and model/service lines Study Team Support Ensures understanding of roles and responsibilities across delivery teams for assigned delivery model(s) / service line(s) Works with AM Process Integration Lead, internal subject matter experts and counterparts in supplier organizations to ensure the effective use and maintenance of interface processes / ways of working (e.g. Alliance Handbooks) Alliance Management Development May have responsibility for line management or coaching of junior members of the team Serves as a delegate for the AM Group Lead for specific tasks or activities, as necessary May support or lead key critical initiatives within AM and contribute to initiatives outside of AM Essential Requirements University degree in related field, or equivalent (Phd/MSc preferred, BSc required with 10+ yrs of experience within the pharmaceutical industry or clinical research organization Strong experience from within the pharmaceutical industry or clinical research organization Detailed knowledge of clinical and pharmaceutical drug development process at various phases of development Experience of working successfully with external partners / managing relationships Experience of directing alliance governance frameworks and processes (incl performance metrics) Strong leadership and influencing skills, especially without authority Strong collaboration skills across global and functional boundaries Excellent conflict resolution, mediation and negotiation skills Ability to work with agility to solve problems that involve many decision makers, and develop multiple options/recommendations Familiar with ICH GCP and related guidelines and practices Why AstraZeneca? At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development. Make a more meaningful impact to patients' lives around the globe! Apply today! Date Posted 15-Dec-2025 Closing Date 06-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.

We have an open position within in our Pharmaceutical Technology and Development (PT&D) department. PT&D is the bridge, which turns brilliant science into actual medicines that help millions of people. We work across the entire value chain, designing and delivering active ingredients, formulations, and devices required to support new medicines - from supplies for use in early toxicology studies and clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture. Make a positive impact, in a team where it means more. In Operations, we have a big ambition. to deliver more medicines to patients, quicker and more affordable. Backed by investment, leadership, and a clear plan to get there, we bring personal dedication and out-of-the-box thinking. Summary: We are currently recruiting for Director of Formulation and Process Design. This position will be accountable for the performance and results within formulation and process design oral/inhaled team - oral solid dosage form experience is required for this position. Key Responsibilities: * Leads a team of formulation scientists, setting clear goals, technical direction, and development priorities to align with organizational and portfolio objectives. Responsible for planning and executing formulation development strategies, optimizing drug product processes, and ensuring robust, scalable, and regulatory-compliant solutions across all stages of development from early-phase through commercial readiness. * Acts as a key interface with other GPD functions to accelerate project timelines and reduce development risk. Drives continuous improvement, talent development, and innovation within the team to support the company's scientific leadership in oral and inhaled delivery platforms Specific Responsibilities: * Leads a team of up to 10 scientists across local and global sites to drive inhaled and oral drug product portfolio * Coaches and develops direct reports to drive high performance, team engagement, and individual growth. * Drives local implementation of PT&D strategy and associated change initiatives, championing transformation and innovation. * Embeds new ways of working that enhance agility, flexibility, efficiency, and delivery, serving as a role model for lean leadership. * Shapes and delivers forward-thinking, digital-enabled approaches to product design and development, leveraging data science, predictive modeling, AI, and strategic workforce planning to meet evolving portfolio needs. * Builds and sustains a high-performing, innovative team culture focused on scientific excellence, new modalities, and continuous improvement. * Ensures full compliance with SHE and cGMP standards, aligning with AZ and external regulatory requirements. * Operates confidently within a global matrix organization, fostering integration and readiness for future challenges. Ensures capability building to support the diverse and emerging portfolio of modalities. * Collaborates with the Project Leadership Group to define and execute portfolio delivery strategies within the unit's remit. * Solves complex scientific and organizational challenges through strategic insight, conceptual thinking, and informed judgment. * Influences internal and external stakeholders, shaping the reputation and impact of the FPD department. * Demonstrates strong communication and leadership skills to set clear direction, inspire teams, and foster alignment across functions. Education, Qualifications, Skills and Experience Essential * BSc/PhD level education in a relevant Engineering field (Packaging Engineering, Mechanical Engineering, Biomedical Engineering, Materials Engineering, Chemical Engineering), or in Pharmaceutical Sciences with related experience in the device and biopharmaceutical industry is essential. * Minimum 5 years relevant experience * Significant experience in the design and development of inhaled and oral products * Proven experiences in leading and managing direct reports * Leadership experience promoting, motivating and empowering diverse and inclusive culture to support accomplishment of individual, team and organisational objectives * Significant understanding of the overall drug development and commercialisation process from development and launch, through life cycle management * Strong Networking skills across complex, multi-national PT&D organization * LEAN leadership mindset Desirable * Ability to lead cross functional working groups and teams * Expert reputation within the business and industry * Extensive knowledge of the latest technical and regulatory developments * Excellent knowledge of AstraZeneca policies, procedures and guidelines 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. Why AstraZeneca: Be part of shaping the future of Operations here at AstraZeneca. Be part of shaping the next phase of Operations' journey towards the 2025 strategy. Build on our foundations of high performance through agility, responsiveness, reliability, and efficiency to deliver our new modalities and complex pipeline to market at speed. Backed by a supportive team, be part of accelerating our operational excellence with innovations in cutting-edge science, Lean ways of working, and fast-changing digital technologies. The annual base pay for this position ranges from $175,572 to $263,358 Annual USD. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Date Posted 13-Nov-2025 Closing Date 30-Dec-2025 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.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network. The purpose of this position is to provide oversight and drive / maintain harmonization of technical programs that govern implementation and execution of Sterility Assurance control strategies across the Lilly Parenteral Network. This position also influences peers within Lilly globally and at the site level, as well as external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also aids and enables building technical capability at Lilly sites to ensure the vital capabilities are developed and in place to meet business objectives. Finally, this role provides ad-hoc technical support to Lilly PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. Responsibilities: * Assess differences in current sterility assurance programs across the sites and drive harmonization * Work closely with site and multi-functional SMEs to drive cohesion. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. * Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. * Assume SME leadership role for a specific topic area within Sterility Assurance across the network, including harmonization of aspects of the topic area and facilitation of the knowledge across the network. * Represent TS/MS on network Science Lead Team and other appropriate governance forums. Ensure that Sterility Assurance programs and similar topics are frequently presented to network team in order to align across sites. Ensure that learnings and best practices are shared across sites: set-up appropriate forums in order to achieve this and present case studies to site SMEs. * Provide mentoring leadership to site SMEs to help build continue to build capability, particularly at the newer sites or where deep technical expertise is lacking. * Building, maintaining, and growing capability across the organization in the sterility assurance space * Provide technical support to new sites/ filling lines during design and start-up activities to ensure sterility assurance programs and process/ product requirements are supported at these sites, particularly while the sites are in early stages of building capability. * Provide technical support for significant sterility assurance investigations to help identify root cause and implement appropriate corrective actions. Share best practices / learnings / CAPAs across the other sites. * Benchmark industry trends and emerging regulatory guidance / requirements in the field through building an extensive peer network and attendance at relevant industry and regulatory meetings and advocacy groups. Advance Lilly agenda in the field. Represent Lilly on relevant external bodies related to Sterility Assurance; be influential in terms of representing Lilly's position on technical/ regulatory positions papers and guidance. Assess new technologies to ensure Lilly stays current with new trends and technologies and share with the network with the goal of staying current with industry best practice. * Work with PR&D on new technology / platform development and implementation for pipeline products. Influence the agenda within PR&D to ensure the needs of Manufacturing are met, and the control strategies are fit for-purpose for robust and compliant commercial manufacturing. * Provide ad-hoc technical support to Lilly organizations outside of the PPN including PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. * Engage in providing support during regulatory interactions such as RtQ of submissions, and on-site inspections * Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals Basic Qualifications: * BS Degree required. * MS/PhD in a biological science preferred. * 10+ years' experience working in Parenteral Sterility Assurance / Environmental Monitoring or equivalent roles preferred. * 10+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment preferred. * Deep technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, Annex 1 interpretation) * Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities * Strong written and oral communication skills * Ability to mentor and develop scientists in the fields of sterility assurance and applied pharmaceutical microbiology * Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance * Demonstrated experience influencing site and network leaders to advance technical agenda projects Additional Preferences: * Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed. * Support the establishment of a sterility assurance network or hub in global TSMS * Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance * Experience in leading external committees or conferences to ensure Lilly remains a leader in the sterility assurance space * Work with engineering SME's to support Lilly platforms to maximize the performance and minimize the risk of sterility assurance * Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options. * Strong capability to influence personnel and management across the organization * Close interaction with quality to enable internal audits that identify risks * Past experience in creating effective working relationships with all levels across internal and external stakeholders impacting the success of sterility assurance. Additional Information: * Approximately 25% travel Lilly currently anticipates that the base salary for this position could range from between $133,500 to $220,000 and will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $133,500 - $246,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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 26-Nov-2025 Closing Date 01-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?** 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. 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.

Boehringer Ingelheim is currently seeking a talented and innovative Pharmaceutical Sales Intern to join our diabetes sales team in one of our nine national regions. You will work with a team of experienced sales professionals who will guide you through a real world, hands-on experience in selling pharmaceuticals. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the company's success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Duties & Responsibilities Participate and successfully complete training and selling skills development. In partnership with a mentor/coach, engage with customers and participate in clinical discussions (including virtual engagements). Attend weekly conference calls with regional field sales team to capture learnings and gain valuable insights. Schedule appointments for sales colleagues and participate in in-service programs. Requirements Must be a current undergraduate student in good academic standing; December 2026 and May 2027 graduates only. Must be enrolled at a college or university for the duration of the internship. Overall cumulative minimum GPA from last completed quarter/semester 3.0 GPA (on a 4.0 scale) preferred Must have completed at least 12 credit hours at current college or university. Must have reliable transportation and valid driver's license. Must be able to work the full duration of the internship (May 18, 2026 - August 14, 2026). Desired Experience, Skills & Abilities: Strong interpersonal skills Digital proficiency Ability to analyze qualitative and quantitative information Demonstrated ability to work in a team environment Ability to execute and follow through on priorities Eligibility Requirements: Must be legally authorized to work in the United States without restriction Must be willing to take a drug test and post-offer physical (if required) Must be 18 years of age or older

Make your mark for patients We are looking for a Head of Statistical Innovation to join us in our Biometrics & Data Science team, based in any of our Brussels (Belgium), Monheim (Germany), Slough (UK) or Atlanta or Raleigh (US) offices. About the role This is a critical enterprise-level leadership role that will shape the future of drug development by driving innovation in statistical design, analysis, and interpretation across all phases of research and development, from early discovery to post-market surveillance. The Head of Statistical Innovation will be responsible for fostering a culture of statistical excellence, influencing strategic decision-making, and ensuring the robust application of cutting-edge quantitative methods to address complex scientific questions. Who you'll work with You will report into the Head of Advanced Methods & Data Science What you'll do Establish and maintain a positive image for UCB statistics worldwide through collaborations, scholarship and professional networking Create a vision and mission for Statistical Innovation and Consultancy within UCB and champion its visibility both internally and externally with the academic, regulatory and scientific community to influence policies and state-of-the-art statistical thinking related to drug development. Provide statistical advice and guidance to the UCB statistical leadership and Senior Management to enable optimal decisions in development, marketing, and lifecycle support of UCB products. Provides strategic counsel to senior executives on quantitative innovation, analytics and opportunity/impact in program strategy/design, mitigations and innovation-enabled excellence with modern analytics and digital business transformation Lead development and championing techniques based on state-of-the-art statistical research and seek creative solutions through collaborations and interactions with other experts for drug development problems. Provide, together with UCB statistical leaders, statistical thought leadership for establishing high-quality, regulatory-compliant statistical approaches to provide well-trained statistical staff at all sites. Interested? For this position you'll need the following education, experience and skills: PhD. required Several years pharmaceutical industry experience with proven successful track record in biopharmaceutical development. Experience successfully building and managing international teams in the field of statistical sciences Proven track record of successful internal and external stakeholder engagement Inspirational leader, able to develop and communicate a vision for the Practice across cultures and geographies Change agent, driving change and innovation to maximize patient value creation Strong publication track record Are you ready to ‘go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you! About us UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science. Why work with us? At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We ‘go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential. UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable federal, state, or local law. UCB invites you to voluntarily self-identify during the application process. Provision of self-identification information is entirely voluntary and a decision to provide or not provide such information will not have any effect on your application for employment, your employment with UCB, or otherwise subject you to any adverse treatment. Any information you provide will be considered confidential and will be kept separate from your application and/or personnel file and will only be used in accordance with applicable laws, orders, and regulations. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on US-Reasonable_Accommodation@ucb.com for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

The Director, Scientific Communications shapes and leads the long-term communications strategy for BioPharma Clinical Operations, elevating the visibility, reputation, and impact of BioPharma ClinOps across R&D and the enterprise. This strategic role partners directly with the Head of Clinical Operations and senior leadership to craft a compelling, science anchored narrative of how Clinical Operations accelerates innovative, patient centric development. The Director will steward integrated internal and external communications, thought leadership, leader visibility, and enterprise storytelling grounded in a deep understanding of clinical development, operational excellence, data/digital transformation, and compliance. Role purpose * Build and execute a multiyear communications strategy for BioPharma Clinical Operations that aligns to R&D and enterprise strategy, advances change adoption, and measurably improves awareness, engagement, and influence. * Serve as a principal advisor and communications lead to the Head of Clinical Operations, providing counsel, executive messaging, and issues management. * Translate complex scientific and operational topics (trials portfolio, digital/data innovation, risk-based quality, patient engagement, sustainability) into clear, compelling narratives for diverse audiences. * Strengthen Clinical Operations' voice and presence inside R&D and across AstraZeneca, and externally with industry partners. Key responsibilities Strategy and leadership * Set the long-term BioPharma Clinical Operations communications vision, priorities, and annual operating plan, with clear KPIs tied to business outcomes (e.g. cycle time, quality culture, talent brand, innovation adoption). * Establish the strategic narrative and messaging architecture for ClinOps 2030, mission, proof points, and signature stories, ensuring consistency across channels and markets. * Advise and coach the Head of Clinical Operations and LT on executive communications, change leadership, and stakeholder engagement. Act as communication lead for LT meetings, town halls, and enterprise forums. * Partner with other Communications team members as an experienced peer, offering guidance, coaching, mentoring, and thought partnership while collaborating on priority initiatives without direct line management. * Partner with R&D, Corporate Affairs, SEN and HR to integrate ClinOps narratives into broader enterprise communications and employer brand. Integrated communications and channels * Own the BioPharma ClinOps editorial calendar, content roadmap, and multichannel strategy (Workvivo posts, video, newsletters, podcasts, town halls, playbooks). * Lead development of high impact content: executive speeches, narratives, video series, infographics, thought leadership articles, and campaign toolkits. * Ensure compliance with regulatory, legal, IP, and data privacy requirements. * Map and manage critical stakeholder groups (ClinOps LT, functions, regions, sites, study teams via appropriate channels), tailor messaging to their needs and maturity. * Drive leader visibility and "leaders as communicators" programs, develop leader communication playbooks and coaching to cascade strategy and reinforce cultural behaviors. * Sponsor key events and flagship moments (ClinOps 2030 milestones, ClinOps Awards, innovation showcases) with measurable engagement and follow through. * Define success metrics across awareness, engagement, behavior change, and business impact. * Conduct audience insights, message testing, and channel analytics to continuously refine strategy, socialize learnings and scale proven practices. Qualifications Essential * Degree in Communications or Journalism. * 5+ years' experience in strategic communications within complex, global organizations, including executive advisory and enterprise change communications. * Pharma R&D experience with direct clinical operations preferred * Proven track record building multiyear communications strategies with measurable business impact. * Experience navigating regulated environments and partnering with Medical/Legal/Regulatory for external content. * Executive presence, stakeholder influence, and the ability to simplify complexity for global audiences. * Strong command of digital channels and analytics; proficiency with content management, enterprise social, Adobe Creative Cloud, and video/podcast production workflows. Desirable * Familiarity with AI assisted content, data storytelling, and measurement platforms. When we put unexpected teams in the same room, we unleash ambitious 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. If you're ready to make a significant impact on patients' lives by joining a team that follows the science with curiosity and courage, apply today! Date Posted 11-Dec-2025 Closing Date 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.

We have an open position within in our Pharmaceutical Technology and Development (PT&D) department. PT&D is the bridge, which turns brilliant science into actual medicines that help millions of people. We work across the entire value chain, designing and delivering active ingredients, formulations, and devices required to support new medicines - from supplies for use in early toxicology studies and clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture. Make a positive impact, in a team where it means more. In Operations, we have a big ambition. to deliver more medicines to patients, quicker and more affordable. Backed by investment, leadership, and a clear plan to get there, we bring personal dedication and out-of-the-box thinking. Summary: As Principal Engineer Continuous Direct Compression (CDC), you will be responsible for coordinating and leading CDC process and equipment design, development and optimisation on late stage oral solid dose drug product development projects. Building predictive tools and digital twins and CDC process development capability to progress the development of oral small molecules within a dynamic team environment will be your key focus. To deliver these goals, you will work and coordinate collaboratively across boundaries with colleagues with diverse scientific expertise e.g. analysts, formulators, engineers, data scientists, materials scientists and other disciplines e.g clinical supply chain, project leadership, regulatory, outsourcing Key Responsibilities: * Lead our engineering capability in CDC, to design and develop robust manufacturing processes for new pharmaceutical formulations, ensuring compliance with industry standards. * Drive effective technical risk management to ensure that appropriate activities are conducted throughout development to deliver robust commercial manufacture * Work effectively with colleagues across Global Product Development, Global Operations and at our external manufacturing partners, to define critical process parameters (CPPs) that influence product quality, in consideration of the wider product control strategy * Expedite adoption and advancement of in silico process modelling and control in CDC, and progress our capabilities in advanced process control * Lead technology transfer and process validation approaches in CDC * Liaise effectively across the AstraZeneca technical and supply network to influence network capability requirements for CDC * Work with equipment manufacturers to evaluate and specify technology improvements, in line with AstraZeneca product and portfolio requirements. * Provide leadership and coaching to other scientists and engineers within the group, supporting their development to build capability essential to the delivery of the present and future project portfolio. * Demonstrate creativity and innovation, driving and supporting a culture of scientific excellence in projects. * Stay updated on industry trends, emerging technologies, and best practices in continuous processing to foster innovation within the organization. Essential Requirements: * BSc/PhD level education in a relevant Engineering field (Packaging Engineering, Mechanical Engineering, Biomedical Engineering, Materials Engineering, Chemical Engineering), or in Pharmaceutical Sciences with related experience in the device and biopharmaceutical industry is essential. * Minimum 5 years relevant experience * Industrial experience in pharmaceutical spray drying with a degree in chemical engineering or a closely related scientific discipline. * Industrial experience in CDC with a degree in chemical engineering or a closely related scientific discipline. * Experience and thorough understanding of oral solid dose drug product development and commercialisation process * Proven track record of delivering multiple and/or complex late-stage oral drug product development projects, including technology transfer, scale up and validation of CDC processes * Experience of using predictive science / digital tools * Experience in development of drug product control strategies, bringing together different aspects of pharmaceutical sciences. * Strong collaborative working and communication skills, including ability to work effectively with colleagues from diverse backgrounds and different skill areas. * Good organisational and planning skills with the ability to deliver to agreed time and quality. * Excellent stakeholder management skills Preferred Skills & Knowledge * Experience in development, scale up and technology transfer of a range of other drug product manufacturing processes, eg granulation, tablet compression, coating * Experience in clinical and commercial regulatory authoring and defence. * Experience of working with external suppliers (such as CMO/CRO for outsourced development and supply) and managing productive relationships. * Experience with automation platforms and process modelling 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. Why AstraZeneca: Be part of shaping the future of Operations here at AstraZeneca. Be part of shaping the next phase of Operations' journey towards the 2025 strategy. Build on our foundations of high performance through agility, responsiveness, reliability, and efficiency to deliver our new modalities and complex pipeline to market at speed. Backed by a supportive team, be part of accelerating our operational excellence with innovations in cutting-edge science, Lean ways of working, and fast-changing digital technologies. The annual base pay for this position ranges from $175,572-$263,358 Annual USD. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Date Posted 13-Nov-2025 Closing Date 30-Dec-2025 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.

Are you an analytical scientist with extensive experience in routine analytical testing supporting development of new products? AstraZeneca's Global Product Development (GPD) team is seeking a Scientist to expand analytical development capabilities especially with testing complex combination products within inhaled portfolio. At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big, and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person. Within Global Product Development, we are seeking an experienced and motivated Scientist with a strong background and hands on experience with testing complex inhalation products, to drive AZ's critical projects through development to commercialization. In this laboratory based and impactful role, you will support routine clinical lot releases, investigation work along with exposure to method development / optimization. You'll work collaboratively across different functions to support key license to operate testing as well as complaint investigation. The role will be in Durham, North Carolina, USA, but is part of AZ's Global Product Development organization with additional sites in Gothenburg, Sweden and Macclesfield, UK. GPD's vision is to work in seamless ways that bring the best of our collective scientific capabilities to develop and deliver innovative and sustainable medicines, making a meaningful impact on patients' quality of life. Within the role, your expert analytical support will range from early phase development work to late-stage cGMP testing. Experience with digital tools and AI is required to support overall vision for GPD. The ideal candidate will be energetic and focused, with a can-do attitude and strong problem-solving and data analytics skills. You will join a highly collaborative international team supporting various projects across different development lifecycles. What you will do: Manages own work to ensure that agreed targets are met in a timely manner and to agreed quality standards and communicating progress appropriately. Performs relevant experiments and interprets results based on a standard methodology in collaboration with formulation and/or device teams. Able to identify aberrant data and effectively communicate with project teams. Play a key role in supporting development work for automation to manual methods for inhalation products such as Delivered Dose Uniformity (DDU), aerodynamic particle size. Support technical and scientific review of data generated by peers. Identify and lead continuous improvement efforts to streamline laboratory operations and eliminate waste, ensuring compliance with GMP/GxP expectations. Champion laboratory automation technologies to improve efficiency and reliability in sample preparation, method execution, and data analysis. Demonstrate an active interest in leveraging AI /ML and other data science tools to enhance analytical results interpretation and workflow performance. Minimum Qualifications: Bachelor's degree with 3+ years experience, or Master's with 0 or more years experience, in Chemistry, Pharmaceutical Sciences, or closely related field. Strong background in analytical methodologies for inhalation dosage forms Hands on experience working with HPLC/UPLC, moisture analyzer, and mass spectrometry is required. Proficiency with analytical software such as Empower, Tiamo, ELN is required. Hands-on proficiency with workflow optimization. Experience with statistical tools such as JMP is preferable. Excellent organizational, problem-solving, and collaborative communication skills. Experience working in a GMP/GxP regulated environment. Strong people, organizational, and communication skills (both written and oral) Preferred Qualifications: Exposure to analytical methodologies for portfolios that vary across modalities and/or dosage formats, including but not limited to oral solid and inhaled products. Familiarity or interest in utilizing data science tools, including AI / ML, to advance analytical interpretation and data flow. Experience collaborating in cross-functional global teams. Why AstraZeneca At AstraZeneca, we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference in medicine, patients, and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth, and development. So What's Next Are you already imagining yourself joining our team? Good, because we can't wait to hear from you! Find out more on Social Media: LinkedIn ************************************** Facebook ******************************************** Instagram ******************************************** About Operations ******************************************* Date Posted 11-Dec-2025 Closing Date 16-Dec-2025 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?** 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 IS Supervisor position is responsible for the Information Technology (IT) functions at a large manufacturing plant, including management, support, problem resolution, and technology implementation as well as management and implementation of all IT projects at that site. The position reports to the Director, Infrastructure and Operations. **Job Description** **ESSENTIAL FUNCTIONS** **:** + Understand business goals & proposed technology solutions. Assess the requirements of technology solutions including estimates of time, staffing & costs to implement & support. Develop or contribute to the development of capital project requests to fund the implementation of technology solutions. + Manage a team of IT professionals / specialists in the implementation of new technology and on-hour / off-hour support of in-place technologies. + Oversees infrastructure and application support for local applications and systems ensuring all routine maintenance, backups & restores, including disaster recovery planning and testing are performed. + Manages procedures for implementations & ongoing support. This includes keeping technologies current & supported, following and enforcing change control procedures, installation instructions, support request instructions, etc. Understand business goals & proposed technology solutions. + Assess the requirements of technology solutions including estimates of time, staffing & costs to implement & support. + Develop or contribute to the development of capital project requests to fund the implementation of technology solutions. + Manage or supervise the implementation of IT projects. + Works as liaison between users and corporate / outsourced support personnel, coordinating support activity to drive issues to root cause and correct issues affecting users at site. + Develop procedures for implementation & ongoing support. This includes keeping technologies current & supported; change control procedures, installation instructions, support request instructions, etc. + Assures site is complaint with all relevant regulatory controls and procedures and corporate standards and ensures security policies for supported systems are maintained. + Develop and maintain plans to ensure the continuity of critical business functions and minimize information loss in the event of a disaster for local site. + Establish and monitor metrics for system quality. + Perform analysis on resolution time, root cause, proper communication with intention to prevent recurrences. **DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS** **:** + Participate in staff meetings and team meetings as required. + Develop understanding of general industry usage of supported technologies. + Develop deep understanding of business processes and business dependencies on supported technologies. + Develop relationships within IT and with vendors to improve collaboration and teamwork necessary to accomplish organizational objectives. + Participate in a development planning process where employee career goals are defined & understood, and development activities are incorporated into the employee objectives. + Other duties as assigned with or without accommodation. **MINIMUM REQUIREMENTS** **:** **_Education:_** Bachelor degree in Information Technology or related business field. **_Experience:_** 10+ Years Information Technology Experience with at least 2 years of people management experience. _Preferred Skills/Qualifications:_ + Strategy - Looks beyond daily activities to see trends in team performance / issues & addresses these trends with appropriate actions; contributes to the development of strategy in a functional area by researching industry trends and proactively proposing solutions to issues faced by the functional area supported. + Project Development - Develops or contributes to the development of CER's to fund IT investments, key contributor to time, resource & cost estimates. + Project Management - May manage large projects directly or establish mechanisms to monitor status of multiple projects being executed concurrently, mentors personnel in project management techniques. + Operational Support - Manages the day-to-day operation of an IT team responsible for multiple technologies. This includes monitoring of up-time, service-level metrics. Includes business alignment responsibilities including cross functional meetings to review progress and discuss priorities of IT tasks. + Financial Accountability - Responsible for managing IT budget for the site, and collaboration with corporate infrastructure team and local finance team to set priorities and track spending. + Communication Skills - Solid communication skills, both written and oral, with very strong customer service orientation and win-win negotiation skills. + Leadership - Leads by example; provides context & motivation to team members. + Administration - Performs administrative functions as required to manage the daily activities of the functional area. **ORGANIZATIONAL RELATIONSHIPS/SCOPE** **:** Managers Information Services personnel at site. **WORKING CONDITIONS:** Manufacturing Plant and Office environment. **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.

Please note this role is on-site 5 days a week and does not have the ability to work remotely. This role is based in Durham, NC. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Responsibilities: Oversees URS, protocols, reports & support records to ensure compliance, timely resolution of documentation, compliance, and quality system issues. Identify, coordinate, execute and provide oversight of validation activities related to the start-up, commissioning, qualification, validation of a cGMP manufacturing facility (including manufacturing equipment, QC lab equipment, utilities). Performs environmental mapping and other miscellaneous validation activities. Evaluates and analyzes validation data for accuracy and adequacy. Supports the development of validation execution strategy and timeline for sustained operation within validated GMP environment. Collaboratively conducts Risk Assessments and Impact assessments and establish system boundaries. Owns validation Lifecycle documents including Validation Plans, Impact Assessments, and Validation Reports. Reviews and supports Computer Systems Validation efforts for global systems. Manages workload to ensure timely approval of validation testing and documentation. Assists Quality Assurance, Production, Quality Control and other departments during inspections or audits. Additional duties may include attendance at client meetings, preparation of project budgets, review of invoices, and any other duties as required to control financial and execution related aspects of project. Other related duties as assigned. Requirements: BS/MS degree in Chemical, Industrial, Mechanical, or related engineering discipline; or Science with 5 years of relevant experience in the pharmaceutical or Biopharmaceutical industry (validation or engineering experience preferred).. Experience with Biosafety cabinet smoke studies. Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for validation of GMP facilities. Experience supporting FDA approved, commercial products. Experience in cGMP environment (IQ, OQ, PQ) is essential. Familiar with current industry best practices, including ASTM e2500 to plan efficient/risk-based validation projects. Experience with validation tools and processes, including environmental mapping and use of Kaye Validator. Familiar with GAMP 5 applications and practices. Excellent technical writing and verbal communication skills. Proficient in Microsoft Word, Excel, PowerPoint, and Project. Experience providing technical support for problems of moderate scope where analysis requires a review of a variety of factors and able to drive toward issue resolution. Skills: Business Continuity. Change Control. Flexibility. General Hse Knowledge. Hvac (Heating Ventilation And Air Conditioning). Including Gdp. Installations (Computer Programs). Knowledge Of Capa. Knowledge Of Gmp. Manufacturing (Production). Project Commissioning. Project Engineering. Project Execution. Risk Management. Root Cause Analysis (Rca). Languages: English Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $89,600 and $166,400/year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call *************** and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $89,600.00 - $166,400.00 Skills Desired Agile (Programming Methodology), Architectural Engineering, Aws (Amazon Web Services), Business Continuity, Business Networking, Change Control, Computer Science, Construction Management, Cost Management, Flexibility, General Hse Knowledge, HVAC (Heating Ventilation And Air Conditioning), Including Gdp, Installations (Computer Programs), Knowledge Of Capa, Knowledge Of Gmp, Knowledge Of Relevant Tools And Systems , Manufacturing Production, Project Commissioning, Project Engineering, Project Execution, Risk Management, Root Cause Analysis (RCA), Software Development, Total Productive Maintenance

**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. 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.