PCI Pharma Services jobs in Madison, WI

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. **Summary:** The Materials Handler I/II/III assists in the day-to-day activities relating to inventory control functions supporting pharmaceutical fill/finish operations. The main responsibility of this position is to assist with all aspects of logistics such as receiving, shipping, data entry, inventory control, labeling and maintaining all associated cGMP documentation as needed. Additional responsibilities include creating and updating log sheets and inventory cards, shipping activities, and all inventory movement functions including updating databases, labeling and maintaining all associated cGMP documentation. **Essential Duties and Responsibilities:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. **Loads and/or unloads material between dock and truck with hand truck where applicable. Moves materials between statuses and locations within the plants** **Processes delivered materials according to procedure placing an added immediacy on temperature sensitive receipts. Delivers received shipments accordingly** **Prepares work-in-process (WIP) and lot specific kits supporting Manufacturing** **Processes manufacturing and shipping supplies as outlined in procedures** **Records and maintains accurate inventory logs for all manufacturing components. Reports on inventory** **Attends semi-annual DOT and IATA training as required** **Conducts materials handling operations in strict accordance with written SOPs** **Performs cycle counts, expiration date maintenance and maintains all material storage locations** **Assures that operations are conducted in compliance with strict cGMP procedures** **Completes chain of custody forms and updates all receiving logs** **Issues lot numbers to incoming materials per established procedure** **Completes QC test requests for sampling and testing of raw materials** **Performs other duties as required** **Special Demands:** The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions. + Must adhere to cGMP requirements and safety policies and practices + Ability to stand and walk for extended periods of time up to 4 hours without a break + Ability to bend and stoop to grasp objects + Ability to lift loads up to 50 pounds, unassisted + Willing to obtain DOT and IATA training/certification + Able to travel from one facility to another as required **Qualifications:** The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. + Minimum of 1 year's experience + Must possess a valid driver's license + High School or Equivalency Basic math and computer skills; ability to use Microsoft Suite + Good written and oral communication skills + Ability to follow instructions and established procedures + Ability to prioritize, to ensure the key actions are followed through + Strong commitment to excellence and quality with a positive working attitude + Knowledge of ERP software is most helpful + APICS coursework or certification helpful, but not required + Strong initiative , reliable, follows instructions both verbal and written + Team oriented with good interpersonal skills Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (***************** **Equal Employment Opportunity (EEO) Statement:** _PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._ _At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._ Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The Senior QA Manager will work with other departments to ensure the quality of products and compliance to internal procedures and external standards. The role supports and provides quality oversight of the day-to-day operations of the Madison, WI based drug manufacturing facility. In this role, the opportunity exists for the incumbent to shape and transform GxP programs by providing QA expertise and guidance to lead product candidates and pipeline assets. The incumbent will also be a key member of a cross functional team focused on harmonization and improvement of quality systems and processes across all PCI WI GMP locations. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. Provides quality oversight of manufacturing activities on a day-to-day basis. Review, develop, and improve quality system procedures, specifications, and test methods. Provide status reports, including relevant quality metrics and participates in the management review process. Establish collaborative relationships with internal and external customers to ensure all quality and compliance matters and any issues that arise are addressed in an open and timely manner. Monitor, identify, and propose quality process/system improvements and provides strategic foresight to identify and implement changes to enhance long term goals of the department and drive continuous improvement. Serve as QA representative to cross functional project teams such as process improvement. Perform risk assessments to comply with internal procedures and external guidelines. Initiate, revise, and review controlled cGMP documents including SOPs, Material Specifications, Investigation protocols/reports, validation protocols/reports as applicable. Ensures site readiness for regulatory inspections, client audits, and internal audits. Perform review of raw material documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization. Assist with internal audits, client audits as well as supplier audits as needed. Review and approve supplier documents requiring Quality approval. Interface with internal and external customers to address any documentation and compliance concerns. Provides oversight to Quality walkthroughs for Shutdown and Inspection Readiness activities and ensures compliance with site and corporate procedures. Establish and communicate performance objectives for Quality Assurance staff that are consistent with the business's unit goals, Quality and Technical Operations objectives. Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment enhances unit performance and integration across site departments. May provide Quality review and approval of investigations, deviations, events, change controls and CAPAs. Hires, integrates, and develops high quality talent, capable of delivering against the department's goals and objectives. Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION AND PROFESSIONAL EXPERIENCE Knowledge of science generally attained through studies resulting in a BS degree in Science, Engineering, Biochemistry or related discipline, or its equivalent is required. ASQ certification preferred. ASQ certification preferred. Minimum of 8 years of pharmaceutical or biotech industry experience with 2+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production. Minimum of 2 years of management responsibility preferred. A minimum of 8 years of overall experience in biopharmaceutical quality Knowledge of biotech bulk and finished product manufacturing, Drug Substance or Drug Product disposition and batch record review is highly desirable. Experience performing RCA, technical writing, and working with quality related investigations. Knowledge of laboratory and production equipment and IQ/OQ/PQ Knowledge of US and EU cGMP regulations and guidance Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9. Background and demonstrated effectiveness in quality assurance operations and compliance of commercial biologics manufacturing with oversight of final product release. Knowledge in Operational Excellence and Continuous Improvement is highly desirable. Experience in building and growing an organization into a high-performance team. Knowledge of electronic systems including any of the following Master Control, or electronic batch recording systems, is desirable. Microsoft Office suite knowledge and proficiency with Excel is desirable. PERSONAL SKILLS & COMPETENCIES Exceptional organizational skills Ability to make risk-based decisions and resolve issues with minimal guidance. Excellent interpersonal skills and the ability to communicate well orally and in writing. Proficiency in MS Office including Word, Excel, Access, and Visio Ability to lead people in a dynamic, fast-paced work environment. Honesty, integrity, respect, and courtesy with all colleagues Creative with the ability to work with minimal supervision and balanced with independent thinking. Resilient through operational and organizational change Demonstrated leadership, interpersonal, communication, and motivation skills. Well-practiced in exercising sound judgment in decision-making Demonstrated multitasking and organization skills. Past experience where one was required to work in a team-based environment with a diverse group of people. Previous work responsibility, which required a high degree of attention to detail. #LI-LL1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Summary of Objective: The Manufacturing Technician I learns and performs a variety of tasks with supervision and in accordance with the manufacturing instruction set inclusive of current GMP/ISO requirement and standards and following all safety guidelines of PCI. With supervision, the technician performs routine and critical manufacturing operations, including but not limited to work functions in equipment prep, formulation, aseptic compounding, and filling activities for biopharma and medical device products. Works with Master production records and standard operating procedures. Conducts self in accordance with the Guardian values and behaviors. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. Maintains and adheres to safe work habits and all applicable PCI safety procedures and guidelines. Demonstrates general knowledge of aseptic techniques. Prepares solutions, aseptic filling, and labeling of vials under sterile and non-sterile conditions, routine solution and filtration, vial and component preparation and sterilization. Assembles, disassembles, and operates aseptic filling equipment and lyophilizer equipment in classified cleanroom and controlled non classified environments. Operates vial capper, unloads product from lyophilizers and liquid fill line. Prepares equipment and components for sterilization and Lyophilization. Operates processing equipment including autoclaves, ovens, vial washers, and depyrogenation, centrifuges, mills equipment. Assists in the formulation and dispensing of product in a clean room environment per SOPs and MBRs Sanitizes production areas and prepares equipment for production. Completes and maintain documentation related to assigned work, including logbooks, batch records, etc. Adheres to verbal instructions and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation. Identifies, escalates and documents events that deviate from normal operation; participate as needed in investigations. Maintains compliance, cleanliness and orderliness of operational areas per appropriate SOPs. Performs COP, CIP, and SIP operations to prepare equipment for manufacturing operations. Reviews and revises pertinent SOPs and production batch records as . Inspire and constantly strive to make PCI a great place to work and respected for the quality of its people and products and clients. Successfully participates in media fill/aseptic proficiency test Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions. Ability to wear personal protective equipment such as safety glasses/goggles, gloves, and safety shoes. Ability to gown and gain entry to controlled manufacturing areas. Ability to lift, pull or push equipment requiring up to 25-50 lbs of force. Ability to stand for 6 hours in a production suite. Ability to work any shift (up to 10 hours) as dependent on business needs. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Interacts with cross functional support teams such as Operations, QA, QC, Engineering, R&D, Validation, etc. This is an individual contributor role. TRAVEL - - Ability to adapt to a changing process daily (i.e., Formulations vary depending on client product) - Able to work under the scrutiny of clients daily - Expected to be flexible with the process and adjust work hours accordingly Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 0 - 2 years of working experience, preferably in a manufacturing environment ideally in the pharmaceutical or medical device industry. Minimum of a High school diploma/equivalency. Ability to weigh and measure raw materials and operate basic Benchtop instruments. Able to follow written instructions. Seeks help with more complex and non-routine tasks. Ability to adapt to a changing process daily (i.e., Formulations vary depending on client product) Able to work under the scrutiny of clients daily Expected to be flexible with the process and adjust work hours accordingly Good verbal and written skills Pay attention to detail. Demonstrates a good mechanical aptitude. Commits to conducting PCI business according to the highest legal and ethical standards, and to continually pursue excellence in the manufacturing and delivery of PCI products and services. Honesty, integrity, respect and courtesy with leadership and peers Openly receives and implements feedback, resilient, able to move past mistakes; applies learning. Self-starter, able to work in a fast dynamic work setting Join us and be part of building the bridge between life changing therapies and patients. Let's talk future. Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. **Responsibilities:** + Effectively working with the team to prioritize work and establish a strong partnership with HR to ensure clear governance in how value is delivered to the end users with the goal of providing an amazing employee experience. + Demonstrate ability to provide Tier 1 & Tier 2 user support, troubleshooting, and education to HRIS users, primarily HR team members. + Partners with HR team members in business process enhancements. Assist in the review, testing and implementation of upgrades or patches. + Support in the maintenance and updating of the HRIS database, including employee records, organizational structures, job profiles, and other relevant data. + Serve as a primary point of contact for HRIS related inquiries by way of the internal ticketing system and appropriately assign tickets to WD support team members. + Partner with cross-functional team members and HR on HRIS-related issues/enhancements/queries. + Participate and contribute to the pro-active review and implementation of process improvements to ensure enhancement of user experience and improve data management. + Communicate and partner with key external vendors as needed. + Generate standard and ad-hoc reports, dashboards, and analytics to support HR and business decision-making. Assist in developing and maintaining regular reporting processes to provide timely and accurate data to stakeholders. + Assure data integrity of internal HR systems and databases; monitor system access and user permissions to safeguard sensitive HR data. + Provide ad-hoc operational support, special programs and initiatives as needed. **Qualifications:** + Bachelor's degree in human resources, information technology, or a related field. + 7+ years of experience with Workday HR information systems (HRIS), including configuration, reporting, and data management. + Workday configuration experience in one or more HR modules: Recruiting, Benefits, Performance, Comp, Payroll, Absence, or Time Tracking. + In depth knowledge & experience with Payroll, Absence, or Time preferred. + Working knowledge of the interdependencies of Workday modules and an awareness of potential downstream impacts of any configuration changes. + Workday Reporting or Integrations experience a plus. + Able to modify/update Workday business processes, eligibility rules, and condition rules. + Ability to navigate stakeholder relationships and accurately gather their requirements. + Effective communication in translating technical information into clear, user-friendly communications for HR and other business partners. + Ability to troubleshoot issues and propose practical solutions. + Adaptable and able to pivot quickly to changing requirements and business needs. \#LI-EK1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (***************** **Equal Employment Opportunity (EEO) Statement:** _PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._ _At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._ Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. This position will have responsibility for supporting activities in the QC Sample Management group, which includes use of material control procedures and specification documents, raw material sampling & inspection, participation in the coordination of testing with internal and external resources, and collection of data and material certificates for review by QA. **Essential Duties and Responsibilities:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. + Review all incoming material receipt packets to assess testing needs + Schedule and perform sampling of raw materials across the PCI Madison, WI Sites + Request quotes and purchase orders for testing performed externally + Assist with regular communications with 3 _rd_ party labs performing external testing + Complete and submit all applicable sample submission paperwork to the appropriate testing labs + Escalate testing failure or safety concerns to management in a timely fashion + Assist in deviation, out-of-specification or aberrant result investigations, as needed + Assist with the writing and revision of cGMP documents and Raw Material Specifications documents to meet industry standards + Assist with reviewing testing results to ensure accuracy and compliance. + Perform routine cleaning of sampling facilities + Routinely perform aseptic sampling inside a Biological Safety Cabinet + Perform dimensional inspections on packaging components + Perform routine data generation and problem solving + Order/restock laboratory and office supplies, as needed. + Complete assigned training in a timely fashion **Special Demands:** The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions. + Must be able to walk and drive between local sites + Must be able to physically wear laboratory protective attire and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves + Must be comfortable working with and handling hazardous materials in safety cabinets **Work Environment:** The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Laboratory, manufacturing, warehouse **Qualifications:** The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. + 0-3 years relevant business experience + Proficient in MS Office. + Must have strong attention to detail as well as ability to work in a cross-functional team environment + Professional interpersonal skills and the ability to communicate well orally and in in writing + Ability to multi-task in a dynamic environment with changing priorities + Ability to work independently as well as on a team, with limited supervisory oversight + Master Control experience a plus + cGMP experience a plus Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (***************** **Equal Employment Opportunity (EEO) Statement:** _PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._ _At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._ Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. **Summary of Objective:** Provide support to the Site Departments to include, but not limited to: receptionist, word processing, administrative duties, communications, and data entry. **Essential Duties and Responsibilities:** **Serve as key receptionist at front desk** **Document preparation including memos, reports, and presentations** **General office operations to include but not limited to: photocopying, faxing, mailing, emailing, office supplies procurement** **Serve as primary contact for internal and external communications** **Information management including site calendars, contact lists** **Meeting and event planning** **Special projects to include research and data analysis** **Other duties as assigned** **While performing the duties of this job, the employee is regularly required to use hands and fingers to handle, feel, or operate objects, tools or controls, and reach with hands and arms.** **Sitting for extended periods of time** **The employee is frequently required to stand, talk and listen.** **Interacts with all departmental staff** **Qualifications:** **Excellent organizational and communication skills** **Detail oriented** **Ability to multi-task** **Word Processing** **Knowledge of MS Office** **Professional verbal and written communication skills** **Attention to detail** **1-3 years of clerical experience** \#LI-LL1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (***************** **Equal Employment Opportunity (EEO) Statement:** _PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._ _At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._ Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. **Summary of Objective:** The senior manager is accountable for all aspects of Engineering, Instrumentation and Controls, Metrology, Utilities, Facilities, and Maintenance in supporting pharmaceutical product manufacturing across the PCI Madison, WI site. The senior manager provides leadership to ensure the highest level of quality and adherence to cGMPs across the site. This role is responsible for managing people, providing quality and technical direction, and actively participating in driving and developing strategies for continuous improvement within the department. Manages and oversees all areas of process engineering, automation, calibration, facilities, operation of utilities including HVAC, buildings and ground maintenance, and maintenance of utilities and facilities supporting aseptic operations. Additionally, responsible for management of site CAPEX projects and acts as site representative for PCI's Environmental, Social, and Governance program. **Essential Duties and Responsibilities:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. + Ensures all aspects of engineering and facilities are adhering to cGMPS and PCI's established SOPs. Makes the necessary recommendations and changes to improve process efficiencies. + Ensures all projects are executed safely, on time, and within budget. + Identifies, prepares and leads site CAPEX projects. + Responsible for all aspects of Engineering, Instrumentation and Controls, Utilities, Facilities, and Maintenance programs. + Determine appropriate equipment, line, tooling, costs and capacities for new projects or changes to existing projects. + Instill a strong culture of Lean and Continuous Improvement through the use of the site maturity index. + Oversees the departmental budget and headcount + Provides coaching, mentoring and development to each direct report both in execution of their group responsibilities and in their own development. + Provides leadership to ensure engineering and facilities support manufacturing operations in a fashion that focuses on quality and adherence to the maintenance schedule in support of Operations + Directs general and specialized maintenance, CAPEX projects, facility renovation, construction, and repair of grounds, buildings, equipment, utility systems, at all manufacturing, warehousing and office facilities within the Madison, WI site. + Support a variety of regulatory and client audits. + Ensures team compliance with all corporate policies and procedures. + Provides guidance to people managers in the areas of compliance, safety, deviations, corrective and preventive actions, and investigations related to engineering, maintenance, and facilities areas. + Works closely with key functions such as Quality, Manufacturing, EH&S, Sales/Project Management, Global Engineering, and Global PMO to ensure internal and external clients' requirements are met. + Analyzes existing processes/unit operations and determine modifications necessary to improve safety, as needed and streamline processes. + Responsible for on time calibration and preventive maintenance schedules for 1300+ site assets including fill line equipment, clean utilities, and laboratory equipment. + Advanced knowledge and understanding of PLC programming and integration that support GMP automated system, vial transport equipment, clean utilities, sterilization equipment, and lyophilizers. + Supports Continuous improvement activities tied to budget goals and helps lead key ESG initiatives. + Directs assigned personnel, including performance evaluations, scheduling, orientation and training. Recommends employee hires, transfers, promotions, salary changes, discipline, terminations and similar actions, as appropriate. + Maintains the professional competence, knowledge and skills necessary for the satisfactory performance of all assigned responsibilities. + Provides leadership in analyzing and developing improvements in process efficiency, quality, safety and client relationships (internal and external). + Correctly implements industry best practices that will successfully withstand regulatory inspections by regulatory authorities. + Responsible for administration of Computerized Maintenance Management System (CMMS) and maintenance planning. + Part of the Site Leadership Team (SLT). + Performs other duties as assigned. **Qualifications:** The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. + Bachelor's degree in engineering discipline preferred. + Master's degree in engineering or business administration preferred. + Operational background in cGMP environment, preferably in aseptic manufacturing/engineering. + Demonstrated skill in managing a diverse population of professional, technical, and hourly personnel as well as external resources. + Experience in working with regulators during inspections/audits is highly desired. + 8+ years of experience in the field of technical engineering support to biopharma/pharm and/or medical device facilities. + 8-10 years of experience in management of professional and technical staff with accountability for objectives and subsequent evaluation. + 5-8 years of experience with engineering and maintenance support to biopharma/pharm and/or medical device facilities. + 5 years of experience managing subordinate people leaders with accountability for objectives and subsequent evaluation. + Experience with company financial systems and an understanding of accounting practices and financials a plus. + Experience with direct exposure to Customers in a CDMO business is a plus. + Demonstrate commitment to continuous improvement at all levels within the organization. + Excellent organizational skills + Ability to prioritize multiple ongoing projects and activities to meet customer and company timelines + Excellent verbal and written communication skills + Ability to effectively manage multiple projects, teams and technical staff at all levels + Ability to assess and develop organizational talent which includes engaging employees and driving technical and personal development. Setting future leadership for success. + Performance measurement and KPI Tracking and Reporting + Proficiency with MS Office suite is preferable. + Possess advanced leadership competencies which support the rigidity of GMP operations against the competing demands of a CDMO environment. + Leads by example to motivate and engage through clear communication, of vision and goals. + Demonstrates resilience and takes a proactive approach to change management to enable leaders to drive the change successfully. + Effective verbal and written communication with both internal and external contacts is critical to success + Oversees a wide array of subordinate managers, supervisors, and technicians across multiple shifts. + Set a clear vision and direction for the reporting functions, encouraging communication and a team-based approach. + **Join us and be part of building the bridge between life changing therapies and patients. Let's talk future** . Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. \#LI-AL1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (***************** **Equal Employment Opportunity (EEO) Statement:** _PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._ _At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._ Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Make a direct impact on patient safety, product quality, and the future of life-saving medicines. At PCI Pharma Services, every vial we produce has the potential to change a life - and we need detail-driven, quality-minded professionals like you to help ensure it. As a Visual Inspection Technician, you'll be the critical last step in the manufacturing process, ensuring our sterile drug products are free from defects before they reach patients. What You'll Do Perform precise visual inspections of sterile-filled vials (both liquid and lyophilized) under controlled lighting to detect even the smallest imperfections. Accurately record inspection results and maintain compliance with Good Documentation Practices. Support related operations, including sampling, packaging, and labeling finished products according to cGMP and SOP requirements. Operate production equipment such as inkjet printers, automated labelers, and label counters. Partner with your team to identify quality issues and recommend process improvements. Maintain a clean, organized work area and follow all safety and GMP guidelines. What You Bring High school diploma or equivalent (required). 2+ years of experience in a GMP-regulated environment (preferred). Keen eye for detail - must meet vision qualifications (20/20 corrected or uncorrected, color vision). Ability to follow written instructions, communicate professionally, and work collaboratively in a team setting. Basic math and computer skills. Integrity, accountability, and a commitment to doing things right the first time. Why Join PCI Pharma Services? Be part of a global leader in pharmaceutical development and manufacturing. Work in a clean, safety-focused environment with purpose-driven colleagues. Contribute directly to the quality and safety of medicines used worldwide. Access training and growth opportunities within a supportive team culture. If you're meticulous, patient, and passionate about quality, this is your chance to help deliver life-changing medicines to the people who need them most. 📩 Apply today and join us in shaping healthier futures. #LI-LL1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The Formulation Technician III mentors others in a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set inclusive of current GMP/ISO requirements and standards and following all safety Guidelines of PCI. With general supervision, the technician performs all manufacturing operations including but not limited to work functions in equipment prep, dispensing, dissolution, formulation, purification, and aseptic compounding activities for biopharma and medical device products. The incumbent must possess the ability to address non routine matters. Utilizes technical knowledge and experience to resolve complex manufacturing problems. Monitors personnel interaction to ensure proper behaviors. Escalates matters requiring resolution by management. Works with Master production records and standard operating procedures. Trains and guides less experienced personnel. Is a model of the Guardian values and behaviors. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. Maintains and adheres to safe work habits and all applicable PCI safety procedures and guidelines. Is proactive in identifying safety risks and alerts management to take corrective action Trains and mentors both peers and less experienced staff in the performance of proper formulation techniques Has ownership for the daily formulation activities to ensure all scheduled tasks/events are completed Is responsible for critical steps in the formulation process including but not limited to, lab setup and process flows, in-process testing, API dissolution and final QS while ensuring safety, batch integrity and prevention of errors that could lead to product and or finical loss Troubleshoots and resolve problems with equipment or processes in the course of performing job duties Adheres to verbal instructions and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation Prepares equipment and components for sterilization and Lyophilization Operates processing equipment including autoclaves, depyrogenation ovens, vial washers, homogenizers, and others Maintains compliance, cleanliness and orderliness of operational areas per appropriate SOPs Collaborates with Supervisor and MTS during drafting of new manufacturing batch records and protocols. Completes Batch Records accurately and completely prior to submission to supervision for review Complies with all area SOPs and ensure logbooks are completed, and adhere to cGMP requirements Initiate and support revisions to SOPs and FORMs as needed Participates in investigations, and contribute to identifying corrective and preventative actions Cross trains to increase technical skills across the department Accountable for timely communication to management and clients of issues, challenges as well as opportunities for process improvements As a member of the manufacturing team, you will perform other manufacturing tasks for example filling, capping etc., as needed Inspire and constantly strive to make PCI a great place to work and respected for the quality of its people and products and clients Work with enabling groups to improve/implement processes Other duties as assigned Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions. Able to stand for long periods of time, the majority of the work shift Able to lift 30lbs repeatedly Able to wear PPE (mask, gloves, respiratory) Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Works directly with aseptic and non-aseptic personnel. Works closely with Quality Assurance, MTS, Validation etc. TRAVEL - < 10% Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. High School education, AS degree or BS degree in related field of study is preferred Experience and knowledge of formulation/compounding tools and equipment Minimum 4 years formulation/compounding work experience in a GMP environment, preferably in fill finish pharmaceutical operations Demonstrated ability to prioritize multiple projects and activities Strong interpersonal skills Strong working knowledge of MS Office suite is preferable Strong communication skills Attention to detail and positive attitude are key attributes Able to follow rules and regulations perfectly Resilient as well as flexible Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. **JOB SUMMARY** The Plant Engineer I provides engineering support throughout the various manufacturing facilities in areas such as process equipment improvements, technological advancements, capital projects, existing manufacturing equipment, cost improvements, facility maintenance, safety and environmental regulation. Demonstrate good engineering, effective collaboration, partnering and teamwork skills when interacting with internal and external resources. **JOB DUTIES** + Support safety through personal engagement and promote individual accountability for safety within the plant Engineering Department. Ensure risks to employee health and safety are rigidly controlled. + Under supervision provide engineering support for Facilities, Systems, Utilities and Equipment (FSUE) execution of projects/assignments from initial concept to final closeout. + Gathers and analyzes information skillfully; Develops alternative solutions; works well in group problem solving situations. provides the technical support for the user with respect to investigations, re-occurring problems, required modifications, optimizations and Continuous Improvements. + Work with end users to develop system requirements, specification of equipment/buildings, support fabrication and perform Factory/Site Acceptance Testing. + Assist in Preparing URS, ETOPs, Risk Assessments, Safety Assessments and other good engineering documents associated with the Facilities, Systems, Utilities and Equipment (FSUE) as required. + Work closely with other support groups such as MTS, Automation, Manufacturing, Quality Assurance, Facility Operations and Maintenance/Metrology, Engineering, EHS&S, and Quality Control to ensure that LSNE assets are well engineered and maintained throughout their lifecycles. + Assist with the factory acceptance testing (FAT), site acceptance testing (SAT), setup, and commissioning of Facilities, Systems, Utilities and Equipment (FSUE). + Procure new equipment, create and maintain the appropriate engineering records including equipment records and manuals, drawings and diagrams, inspection reports per Good Engineering policies. + Support the execution of start-up and commissioning activities on Equipment, utility and GMP manufacturing Facilities, Systems, Utilities and Equipment + Troubleshooting Equipment/system failures, author deviations for unusual operations. **PROFESSIONAL SKILLS** + Good organizational ability coupled with strong communication skills, oral and written + Demonstrated proficiency in the application of basic manufacturing, engineering, and/or scientific theories, principles, and techniques used in biopharma/medical device processes. + Proficiency with standard software applications, including MS Word, MS Excel, MS Project, MS Power Point. + Working knowledge of Solid Works, AutoCAD; 3D modeling experience a plus. **EXPERIENCE** + Process control and Instrumentation for facility control systems experience is desired. + Experience with Computerized Maintenance systems (CMMS), AutoCAD, SolidWorks, PLC & SCADA control system. Knowledge of GMPs is essential, but not required as these can be learned on the job. + Experience working in a GMP and FDA regulatory environment for drugs and/or medical devices a plus. **EDUCATION** + BS in Chemical, Mechanical, or other Engineering degree from an accredited university. + A minimum of 0-2 years' experience in engineering, facilities clean utilities and/or plant utilities, preferably in the biotechnology, medical device or pharmaceutical industry. **QUALITIES** + Effectively support internal and external relationships, key stakeholders and vendors. + Good understanding of team and group dynamics, contributes to creating a positive culture. + Has capacity for agility to working in a fast paced CMO environment. + Good Technical writing skills \#LI-AK2 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (***************** **Equal Employment Opportunity (EEO) Statement:** _PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._ _At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._ Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The Facilities Supervisor is the key liaison to the facilities department to ensure that installed systems meet all applicable codes and standards, support cGMP manufacturing operations and are maintained in accordance with a well-established preventative maintenance program. The Facilities Supervisor's primary responsibilities are to support facilities management in planning, maintaining, scheduling, implementing best practices, improving and promoting safety for the Facilities, Systems, Utilities and Equipment (FSUE). The incumbent supervises the GMP maintenance staff and will be responsible for execution of the day-to-day maintenance to maintain (FSUE) in an operational state compliant with regulatory requirements for a GMP environment. Responsible for driving the PCI culture through values inclusive of customer service standards. Accountable for outstanding customer service to all external and internal functional teams. **Essential Duties and Responsibilities:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. + Promote safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards. + Responsible for supervision of maintenance and Facilities activities for 24/7 GMP operations. + Establish all required preventive maintenance plans utilizing the Regulatory Asset Manager (RAM) System. + Ensure preventive maintenance work plans are current, accurate, written with sufficient detail, and executed + Provide long term solutions and day-to-day support to all operating teams having issues with troubleshooting, problem analysis, equipment failures, etc. + Generate, revise and review cGMP documentation to ensure compliance to all applicable governing bodies. + Support Quality Incident Investigations, CAPAs and ensure completion of assigned CAPAs completely on time. + In collaboration with Facility Manager, ensure technicians are adequately trained on site facility and systems + Schedule and coordinate shutdowns to include preventative maintenance, projects, and facility modifications. + In collaboration with Facilities Manager, prioritize and plan work activities for maintenance technicians; use time efficiently; develop realistic action plans. Work closely with other cross functional support groups + Supervise assets and spare part usage for manufacturing equipment and make changes to improve cost and efficiency. + Support the implementation and supervision of predictive, corrective and preventive maintenance to meet GMPs. + Organize, review, prioritize, and schedule daily Maintenance Work Orders (MWO) and Preventative Maintenance (PM) work. Efficiently coordinate the workflow and documentation of PMs and WOs. + Monitor and report equipment performance and efficiency data and identify any trending. Using data analysis, troubleshoot and determine root cause of equipment failures and develop solutions to prevent future failures. + Drive proper cGMP documentation practices and data quality. Utilizes system to manage internal and external resources according to established workflows. + Ensure that all areas and equipment are maintained in Good Housekeeping condition and facilities are always in inspection/audit ready states. **Special Demands:** The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions. **PHYSICAL REQUIREMENTS** + Frequent standing, walking, bending, kneeling, squatting, and reaching + Able to lift up to 50 lbs. + The employee must occasionally lift and/or move up to 50 pounds **MANAGERIAL & SUPERVISORY RESPONSIBILITIES** + Engage, motivate and positively influence others in the pursuit of achieving PCI goals and objectives. + Participates in interviewing, hiring and issuing disciplinary actions to employees as required with accurate tracking and documentation. Conducts annual employee reviews in a fair, timely manner **TRAVEL** < 10% or >20%) **Work Environment:** The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. + Ability to work in a face paced environment + Resilient through operational change + Able to work in a highly complex environment with competing demands and priorities + Ability to work varied hours as required by the production schedule **Qualifications:** The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. **EDUCATION** + AS/BS degree or equivalent experience and Proven 3 years' experience in a GMP Facility in a technical role. **EXPERIENCE** + Extensive knowledge of utility and facility equipment such as HVAC air handlers, refrigeration, cold rooms, freeze dryers, steam, chillers, cooling tower, pumps & drives, WFI, RODI, Fill finish equipment, waste and emergency generators. + Have working knowledge of hazardous chemicals and their disposal, OSHA, EPA, and FDA requirements. + Requires in-depth knowledge of cGMPs as they relate to facilities maintenance to ensure processes and facilities are compliant and changes are consistent with necessary controls. Experience with Microsoft Office Suite, RAM, + Demonstrated skills in leadership, communication, teamwork, and change management. **PROFESSIONAL SKILLS** + Help to promote a maintenance culture which embraces reliability-centered maintenance tools to drive continuous improvement with the maintenance team. This includes highly effective maintenance planning, execution, spare parts, and improvement in equipment reliability. + Provide excellent customer service and create strong partnerships with internal and external partners including Quality Assurance, Material Management, Quality Control, Manufacturing, Engineering, EH&S, Finance, and IT + Excellent written and verbal communications skills. + Strong organizational skills and the ability to meet deadlines with minimal supervision. + Read electrical schematics and single line diagrams. Must be able to work in a clean room/ISO environment. + Demonstrated skills in leadership, communication, teamwork, and change management. **QUALITIES** + Possess strong attention to detail + Team oriented with the demonstrated capacity to lead and mentor others + Results driven individual who models this trait for the team + Calm under pressure and able to think clearly to link day to day work to business objectives + Highly collaborative and has ease in engaging cross functional teams to solve challenges \#LI-LL1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (***************** **Equal Employment Opportunity (EEO) Statement:** _PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._ _At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._ Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. **Step Into Quality. Start Your Career with Purpose.** Are you eager to build your career in pharmaceutical manufacturing while making a meaningful impact on product quality and patient safety? Join us at PCI as a **Quality Associate I - Operations** , where you'll be on the front lines of GMP production-supporting real-time quality oversight, solving problems as they arise, and ensuring that every product meets the highest standards of safety, efficacy, and compliance. This is an ideal role for early-career professionals passionate about science, quality, and continuous improvement. You'll receive hands-on training, mentorship, and exposure to industry best practices while working in a fast-paced, collaborative environment. **What You'll Do** + Provide real-time QA support on the production floor: observe critical operations, audit procedures, and monitor compliance during GMP manufacturing + Perform in-process reviews of executed batch records and documentation for completeness and accuracy + Participate in lot disposition and review of drug product and intermediates + Act as a first responder to quality issues, documenting investigations and supporting immediate corrective actions + Conduct Acceptable Quality Limit (AQL) visual inspections of drug product + Support deviation documentation, root cause investigations (using tools like 5 Whys, Fishbone), and CAPA processes + Collaborate across departments and represent QA during manufacturing activities and process improvements + Contribute to SOP revisions, quality initiatives, and regulatory readiness **What You Bring** + Bachelor's degree in a relevant scientific field (preferred) + 0-2 years of experience in the pharmaceutical or biotech industry + 1+ years of experience in QA Operations (preferred) + Understanding of GMP regulations (21 CFR 210/211/820); exposure to ICH guidelines and risk tools (FMEA, HACCP, ICH Q9) a plus + Strong organizational and technical writing skills, with attention to detail + Familiarity with Microsoft Word, Excel, and Outlook + Ability to manage multiple tasks and communicate effectively across teams + Self-starter mindset with the ability to work independently and escalate issues appropriately + Flexible and adaptable to fast-paced, evolving environments **Preferred but Not Required** + ASQ certification + Exposure to Lean/Operational Excellence methodologies + Experience supporting commercial or late-stage clinical GMP operations \#LI-LL1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (***************** **Equal Employment Opportunity (EEO) Statement:** _PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._ _At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._ Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Responsible for leading QA Associates, who provide QA support in the manufacturing of clinical and commercial drug products, to ensure compliance with the principles and guidelines of cGMP. The Supervisor, QA Ops assists in maintaining quality systems, management of investigations, materials management and providing QA support in real time for manufacturing, to ensure control of the manufacturing process. This position will actively partner with Manufacturing Operations, Facilities, Materials Management, and other supporting departments to provide compliance and technical guidance to ensure quality issues are identified and resolved in a timely manner. **Essential Duties and Responsibilities:** + Provide QA support for cGMP manufacturing operations. + Coordinate with cross-functional teams to continually improve procedures with respect to area line clearances, labeling, packaging and material release. + Support QA scheduling activities by monitoring the production, and visual inspection schedules and project management deliverables, and reviewing factors that may impact schedules. + Oversee Quality System Events (QSEs) by verifying a Quality reviewer has been assigned to the QSE and monitor that the QSEs are being completed on time. Assist where needed. + Lead Associates in providing QA on the floor oversight of manufacturing. + Oversee and assist employees with product / material labeling and disposition functions, routine manufacturing area line clearances, AQL Sampling and Inspection of Final Package Lots. + Supervise the employees in the Quality Assurance Department. + Ensure all training is performed by employees, including aseptic gowning, facility flow and visual + inspection. + Maintain Quality Metrics for the company. + Review of master and executed raw material records. Release raw materials, as necessary. + Review of associated QC data to support facility and products, as applicable + 12. Review Quality logbooks, as applicable. + 13. Responsible for writing and revising Standard Operating Procedures, specifications, material control + procedures, deviations, CAPA's, and Quality Investigations when applicable. + Direct involvement in supporting external client audits at PCI and regulatory inspections, and responsible for responding to audit observations, as applicable. + Obtain gown qualification for sterile manufacturing line clears. + Assist with Change Control, as needed + Maintain and evaluate procedures and monitor new regulations. + This position may require overtime and/or weekend work. + Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. + Attendance to work is an essential function of this position + Performs other duties as assigned by Manager/Supervisor. **Qualifications:** **Required:** + BS degree in a scientific discipline + Minimum 5+ year's relevant GMP experience. + Knowledge of FDA/ISO regulatory requirements as well as industry trends. + Computer knowledge, including Microsoft Office, Windows. + Excellent interpersonal skills, must be able to lead and make decisions. + College Level Mathematical Skills **Preferred:** + Experience supporting manufacturing and conducting training is preferred. + Previous supervisory experience is preferred. + Experience executing GMP quality systems in a pharmaceutical/biotech/medical device environment preferred. \#LI-LL1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (***************** **Equal Employment Opportunity (EEO) Statement:** _PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._ _At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._ Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. What You'll Do As a Process Equipment Specialist, you will: Set up filling lines for daily production runs to guarantee on-time starts. Operate and maintain multiple pieces of complex equipment in compliance with Batch Record instructions and cGMP requirements. Troubleshoot, repair, and adjust fill line and support equipment, documenting permanent changes as needed. Perform routine maintenance and help manage spare parts inventory. Lead process improvement projects and equipment upgrades for filling lines and cleanroom operations. Train and coach operators on proper machine function, adjustments, and troubleshooting techniques. Use PLC/HMIs (maintenance mode) and diagnostic tools (e.g., multimeter) to resolve issues. Accurately document activities in both paper and automated systems with strong attention to detail. Maintain gowning certification and comply with cleanroom hygiene requirements. Support other maintenance functions (preventative/corrective) across the facility as needed. What You Bring High School Diploma or GED required; advanced mechanical training or an Associate's Degree in Engineering Technology preferred. 5+ years of hands-on experience in a technical field working with PLC-operated equipment (pharmaceutical/aseptic manufacturing experience preferred). Strong mechanical aptitude with the ability to troubleshoot and resolve complex issues. Proficiency in working with automated systems and software. Ability to work independently and collaboratively in a fast-paced, regulated manufacturing environment. Excellent documentation skills and attention to detail. Why Join Us Be the SME for state-of-the-art pharmaceutical equipment. Work in a highly collaborative environment with cross-functional teams and client interaction opportunities. Gain exposure to aseptic manufacturing and advanced automation. Contribute to process improvements that directly impact production reliability and patient safety. Grow your career in a company committed to innovation, quality, and continuous learning. #LI-LL1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Project Manager II Are you ready to take your project management career to the next level? We're looking for a proactive and experienced Project Manager II to join our growing team and lead multiple clinical projects in a fast-paced, client-focused environment. This is a dynamic opportunity for a driven professional with a background in life sciences or the pharmaceutical industry who thrives on cross-functional collaboration, client satisfaction, and delivering results on complex projects. As a Project Manager II, you'll oversee clinical projects from initiation to closeout, ensuring that they're delivered on time, within scope, and aligned with company goals. You'll manage primarily Tier II and Tier III projects and play a key role in maintaining strong relationships with clients across North American sites. Your responsibilities will include: Leading multidisciplinary project teams and serving as the key liaison between clients and internal stakeholders Planning and launching successful project kick-offs, including facilitating technical transfers Managing and maintaining detailed project timelines, documentation, and scope requirements Ensuring timely procurement of equipment and materials Coordinating internal and external communications to ensure all project updates, risks, and changes are clearly conveyed Addressing and escalating client issues as needed to ensure satisfaction and project alignment Supporting internal initiatives and mentoring junior team members when applicable Reviewing and maintaining essential project documentation (MCPs, batch records, validation protocols, etc.) Overseeing the shipment and tracking of samples and results across departments Working flexibly to support key project milestones-even beyond standard hours when needed What You Bring 4-6 years of project management experience (pharma or medical device experience preferred) Bachelor's degree (Life Sciences focus strongly preferred) Strong technical knowledge of clinical manufacturing, with experience in fill/finish and lyophilization a big plus Proficiency in project management tools: Microsoft Project, Excel, Word, Access, and Smartsheet Excellent communication skills and the ability to manage complex client relationships Strong critical thinking, problem-solving, and time-management skills Detail-oriented with the ability to juggle multiple tasks in a fast-paced, regulated environment You're a Great Fit If You… Have a natural ability to lead and collaborate across departments Thrive under pressure and can manage ambiguity with confidence Take ownership of your work and bring a solutions-focused mindset Are committed to integrity, excellence, and building long-lasting relationships Can balance the big picture with the details that drive project success Physical & Mental Demands Occasional lifting of materials Extended work at a computer Ability to manage multiple priorities and tasks simultaneously Flexibility to adapt to changing project scopes and deadlines #LI-LL1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. **Summary of Objective:** Conducts sampling and testing of production environments, and/or facility clean utilities, as per approved procedures. Performs Lab work and other tasks as assigned by management. **Essential Duties and Responsibilities:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. - Perform routine Environmental Monitoring of the classified clean rooms - Monitor classified clean rooms during manufacturing operations, must gown qualify - Sample and test the Water for Injection System, USP Purified Water systems and Clean Steam systems; perform and document plate reads for all environmental and utility testing with minimal supervision - Write and execute protocols/experiments/SOPs under limited supervision - Reviews work of peers and SOP document changes under limited supervision - May assist senior staff in preparation of investigations, reports and execution of complex protocols - Visual inspection of media fill vials and plates - Perform general lab maintenance/housekeeping - Training of staff in routine processes - Other duties as assigned **Special Demands:** The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions. - Required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear - Ability to sit or stand for prolonged periods of time - Must be able to walk and drive between locations - Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves - Must be able to occasionally lift and/or move up to 50 pounds - Must pass eye exam - Comfortable with working/handling of hazardous materials - Follow written instructions. Perform independent troubleshooting of common issues. - Able to work in a highly complex environment with competing demands and priorities **Work Environment:** The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. - Required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear. - Ability to sit or stand for prolonged periods of time. - Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. - Must be able to occasionally lift and/or move up to 25 pounds. - Follow written instructions. Perform independent troubleshooting of common issues. Provide expertise for response to complex issues. - Able to work in a highly complex environment with competing demands and priorities. **Qualifications:** The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. - High School Diploma required. BS/BA degree in Microbiology or related scientific field preferred. - 3-5 years' experience in a cGMP environment. Two years of experience may be replaced by Associates/Non- Scientific Bachelor's degree. Four years of experience may be replaced with BS/BA degree in Microbiology or related scientific field. - Detail oriented - Ability to multi-task - Ability to gown to work in an ISO-5 environment - Ability to work varied hours as required by the production schedule **\#LI - LL1** Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (***************** **Equal Employment Opportunity (EEO) Statement:** _PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._ _At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._ Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Summary of Objective: Conducts sampling and testing of production environments, and/or facility clean utilities, as per approved procedures. Performs Lab work and other tasks as assigned by management. Essential Duties: •Maintains and adheres to safe work habits and all applicable PCI safety procedures and guidelines. Is proactive in identifying safety risks and alerts management to take corrective action. •Completes routine environmental monitoring of clean rooms, as per approved procedures over multiple local production sites. •Completes environmental monitoring of clean rooms during manufacturing, as per approved procedures over multiple local production sites. •Utility sampling, as per approved procedures over multiple local production sites. •Completed daily and weekly assigned tasks in the Microbiology Laboratory •Adheres to verbal instructions and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation •Complete data verifications checks and/or inputs •Other duties as assigned Special Demands: •This position requires frequent movement between different buildings for various tasks and responsibilities. •A key aspect of this role is the need for aseptic gowning and meticulous compliance with gowning procedures during clean room operations PHYSICAL REQUIREMENTS - •Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes. •Ability to gown and gain entry to controlled manufacturing areas •Ability to lift, pull or push equipment requiring up to 15-20 lbs of force •Ability to stand for 6 hours in a production suite •Ability to work any shift (up to 10 hours) as dependent on business needs Work Environment •Ability to work in a face paced environment •Must be able to travel between multiple local production •Resilient through operational change •Able to work in a highly complex environment with competing demands and priorities •Ability to work varied hours as required by the production schedule Qualifications: • Exceptional organizational skills • Following written instructions • Detail oriented • Ability to multi-task • Word Processing, XL spreadsheets • Competent in MS Office • Professional verbal and written communication skills • High school diploma or its equivalent Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The Facilities Specialist is a critical technical and administrative resource within the Engineering & Facilities team, responsible for executing and coordinating a broad range of activities essential to sustaining compliant pharmaceutical operations. This role serves as the central point of contact for facility badge management, quality system documentation, vendor coordination, procurement of maintenance and calibration resources, and the planning and execution of semiannual plant shutdowns. Additionally, the Facilities Specialist leads special projects tied to complex pharmaceutical equipment lifecycle management - from procurement through qualification and decommissioning - ensuring all activities align with regulatory standards and business objectives. **Essential Duties and Responsibilities:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. + Drive timely completion and documentation of Quality System Events (Events, Deviations, CAPAs, NCRs) acting as the point of contact for all departmental quality investigations. + Coordinate and maintain vendor relationships for maintenance and calibration services; support contract negotiations and ensure vendor compliance. + Develop and execute semiannual shutdown plans with cross-functional teams to complete all maintenance, calibration, and validation activities. + Source and procure maintenance and calibration tools, spare parts, and equipment; manage inventories to support uninterrupted GMP operations. + Support departmental CMMS needs, equipment onboarding, work plan template creating/editing, work order reviews, and asset decommissioning. + Lead or support special projects for complex equipment lifecycle management, including specification, installation, qualification, periodic review, and decommissioning. + Maintain GMP documentation, support audits, and serve as technical point of contact for facilities processes. + Manage and administer badge access control systems, conduct routine audits, and ensure compliance with internal procedures and regulatory requirements.. **COMMUNICATIONS & CONTACTS** + Interacts with all departmental staff, as well as site leadership team + Ensure alignment with PCI corporate initiatives through communication and direct involvement + Interact and negotiate with a broad variety of contractors and vendors, and internal/external procurement teams + Coordinate, lead, and drive various utility and equipment projects (full lifecycle) **Work Environment:** The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. + Ability to multi-task and work productively in a demanding manufacturing environment with changing priorities + Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes. + Minimal travel requirements **EDUCATION, PROFESSIONAL SKILLS, & EXPERIENCE** + Associates/Bachelor of Science degree in technical discipline such as engineering, chemistry, or biology required + Minimum of 5 years' relevant experience in a technical field with demonstrated facilities maintenance and calibration experience + Experience working in an aseptic manufacturing environment preferred + High level of attention to detail + Ability to work independently + Good documentation skills \#LI-LL1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (***************** **Equal Employment Opportunity (EEO) Statement:** _PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._ _At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._ Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. **Summary of Objective:** This position will have responsibility to support various activities in the Quality Control Laboratory. This includes testing the following sample types R&D, in-process, finished product, stability, as well as raw materials. Job duties may also include assisting in the performance of instrument validations, cleaning validations, and method qualifications as deemed appropriate by management **Essential Duties and Responsibilities:** + Perform routine analytical testing of samples supporting incoming raw materials, in-process production, finished product release, long term stability and validation samples. + Assist in deviation investigation, out-of-specification or aberrant results and process changes + Assist in authoring and/or review of GMP documentation including test methods, protocols, reports and raw data + Perform analytical equipment validation, and ensure routine calibration and preventive maintenance is performed at the required intervals with support + Logging and tracking of samples and chemicals. Order chemicals and laboratory supplies as needed + Documents/peer reviews laboratory work using laboratory notebooks/worksheets. Documentation must be detailed, timely and in compliance with cGMP/GDP requirements + May participate in communication between PCI, clients, and analytical testing vendors to support activities including release testing, analytical methods transfer, qualification, validation and implementation + Performs routine data generation and problem solving + Other duties, as assigned **Special Demands:** + Required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear + Ability to sit or stand for prolong periods of time + Must be able to walk and drive between locations + Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves + Must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly + Must be able to occasionally lift and/or move up to 50 pounds + Comfortable with working/handling of hazardous materials **Work Environment:** Works closely with quality assurance and quality control staff in performing varied work procedures and activities. Interacts with Operations staff. **Qualifications:** + 0-3 years relevant Analytical Chemistry experience, preferably in Quality Control + Bachelor of Science in Analytical Chemistry, Chemistry, Pharmaceutical Sciences or a closely related area of study + General knowledge of analytical techniques using instruments such as: UPLC, HPLC, GC, FTIR, UV/VIS, Karl Fisher, Particle Size Analyzer, Densitometer and Osmometer is preferred + Excellent organizational skills and ability to document technical data + Excellent interpersonal skills and the ability to communicate well orally and in writing to all levels of the organization + Ability to multi-task in a dynamic environment with changing priorities + Must have strong attention to detail, strong problem-solving skills, as well as the ability to work in a cross-functional team environment. \#LI-LL1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (***************** **Equal Employment Opportunity (EEO) Statement:** _PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._ _At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._ Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled