About the position
Catalent Pharma Solutions is looking to hire a Lead Specialist, QA Validation & Engineering to support our growing team in Harmans, MD. Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing. The Lead Specialist, QA - Validation & Quality Engineering is responsible for providing Quality oversight of Catalent’s Facilities, Engineering and Validation groups to ensure compliance with applicable US regulations, guidance's, industry standards and Catalent policies/procedures supporting the commercial GMP manufacturing of biological drug substance and drug product. This position will provide continuous improvement support to process, equipment, utilities and computer systems and serve as the key Quality resource for the Engineering, Facilities and Validation organizations. This is a full-time onsite position working Days; Monday – Friday, 8am-5pm. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.
Responsibilities
- Serve as the QA liaison with the Facility, Engineering and Validation organizations to support company goals, client projects, continuous improvement initiatives and as a general resource.
- Interface and communicate with the Client, Validation, Engineering and Facilities departments in meeting project timelines, providing deliverables and resolving issues.
- Represent Quality in client/stakeholder meetings regarding new projects and establishing timelines.
- Lead projects from the planning stage to completion in a Quality role.
- Support the Computerized System Validation Lifecycle to ensure compliance to 21 CFR Part 11, Eudralex Annex 11 and applicable FDA/EMA Guidance's on electronic data integrity.
- Review and approve Protocols and Summary Reports for Process Validation such as PPQ’s, Engineering studies, Cleaning Validation, etc.
- Review and approve equipment qualification protocols such as IQ/OQ/PQ for various equipment such as bioreactors, chromatography systems, controlled temperature units, filling/stoppering machines, autoclaves and critical utilities.
- Support review of the facility Validation Master Plan (VMP).
- Support the Risk Management Program to evaluate and mitigate risks associated with equipment and facilities as appropriate using tools such as Failure Modes Effects and Analysis (FMEA), Fault Tree Analysis (FTA) or other available risk management tools.
- Serve as the QA resource for expansion projects which includes construction of cleanrooms, commissioning, and qualification of utilities such as HVACs, Process Gases, Water for Injection (WFI) and EMPQ of cleanrooms.
- Serve as QA resource supporting the facility and equipment change management program, including review of applicable change controls to ensure appropriate activities are performed and documented supporting the introduction or change to equipment and facilities.
- Provide QA support to the Calibration Program, including review and approval of new calibration plans/procedures, completed calibrations, and compliance to the calibration schedule.
- Provide QA support of the Maintenance Program, including QA review and approval of Preventive Maintenance (PM) plans/procedures ensuring their content and frequency are suitable for the intended application.
- Review and approve Standard Operating Procedures (SOPs).
- Participate in site and corporate quality and process improvement initiatives.
- Support regulatory (FDA, EMA, PMDA, ANVISA, etc.) and client audits/inspections of Catalent.
- Other duties as assigned.
Requirements
- Masters’ degree in a Scientific, Engineering or Biotech field with 6 years’ experience within the biologic, pharmaceutical or medical device industry performing direct hands-on work in a Quality Assurance function OR Bachelor's degree in a Scientific, Engineering or Biotech field with 8 plus years’ experience within the biologic, pharmaceutical or medical device industry performing direct hands-on work in a Quality Assurance function.
- Experience performing/supporting validations associated to IQ, OQ & PQ for Controlled Temperature Units (CTUS’s) such as freezers, refrigerators, incubators, autoclave and biologics manufacturing equipment.
- Strong knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs.
- Experience in writing deviations and investigations.
- Able to work in a team setting and independently under minimum supervision.
- SME/Expert in all Microsoft Applications i.e. EXCEL, PowerPoint, Access, Teams and SharePoint.
- Proficient with electronic systems, including developing and producing reports and can quickly learn and navigate new electronic systems.
- Ability to work in fast paced environment supporting the quality assurance/facilities/engineering departments of a CMO for Phase I/II/III GMP manufacturing of biologic bulk drug substance and sterile finished drug product.
Nice-to-haves
- Experience with Facility Expansion and Aseptic Processing is a plus.
Benefits
- Potential for career growth within an expanding team.
- Defined career path and annual performance review & feedback process.
- Cross-functional exposure to other areas within the organization.
- Medical, Dental, Vision, and 401K are all offered from day one of employment.
- 152 hours of PTO and 8 paid holidays.
- Opportunity to work on Continuous Improvement Processes.
