The Validation Manager is responsible for managing a group of validation specialists in the Engineering Validation Department in support of Plasma Fractionation and Pharma Purification Manufacturing Activities at the Los Angeles and Van Nuys site. Provides general direction to technical staff.
This position will provide expertise and leadership in validation strategy to the site and global projects. This position will have engineering validation oversight and engineering validation signatory responsibility for approval of commissioning, qualification, validation, and final report documents. This position will work in close cooperation with the manufacturing business units, Engineering, Regulatory, QC, and Quality Operations on a day-to-day basis.
This position will provide interpretation of regulatory requirements and provide input and guidance in relation to validation regulatory requirements. This position will provide scientific/technical expertise and consultation in cross functional project teams and to other members of the Engineering Validation department. This position will assist in the review and preparation of regulatory submissions.
Essential Duties and Responsibilities
- Manage, identify, hire, and develop team to support validation activities. Manage continued growth, development, and retention of the team.
- Applies thorough understanding of cGXPs, GAMP5 and 21CFR Part 11 (as applicable), relevant SOP curriculum, routine project procedures, and other training as appropriate.
- Responsible for planning, scheduling, and leading validation assignments. Must demonstrate competent and effective planning, coordination, and organizational skills.
- Lead and interface with cross-functional team members (Engineering, Manufacturing, Regulatory Affairs, Quality Operations, Quality Validation, Supply Chain, and other technical disciplines) representing the respective validation elements, as applicable, to determine validation strategy and system validation requirements based on concepts of life cycle: user requirements, functional specifications, design specifications, commissioning and validation. Emphasis is on ensuring validation activities meet regulatory guidelines and industry standards.
- Guide peers in Validation and Engineering Departments to use sound, statistically based Quality Engineering approaches in project, test plans and in analyses and interpretation of test results.
- Identify gaps related to validation requirements and Global Validation procedures. Drive and close compliance gaps as they are identified.
- Review documentation for accuracy and compliance to established procedures with the ability to approve or reject as appropriate.
- Ability to present a course of action to management and project team using both written and verbal communication tools.
- Assist with regulatory agency inspections, including interfacing with inspectors and corporate/division/internal auditors. Present validation strategy and protocols in regulatory inspections.
- Supervise, as needed, other validation personnel, contractors and outside vendors to meet project timelines, goals and milestones.
- Monitor and report validation costs including capital and cross-functional expenses.
- Lead in the drafting and implementation of Global Validation procedures including initiatives for harmonization and streamlining efforts. Develop and implement new validation approaches as needed.
- Provide planning and scheduling support for validation projects. Responsible for defining validation scope of work, resources, and duration for projects to meet site-wide validation and budgetary goals.
- Perform other duties as directed by supervisor.
- Must have vast experience, proficiency and leadership in pharmaceutical/biotech validation elements, which includes the writing and executing of protocols and standard operating procedures.
- Must be considered a proficient Subject Matter Expert (SME) in all validation elements.
- Must have exceptional organizational skills and ability to analyze and plan and implement resolutions to technical problems, familiarity with auditing techniques, interpreting regulations and quality systems.
- Must be proficient with Microsoft Office including MS Word, Excel, Power Point, Visio and Project.
- Leadership and project management skills such as exceptional interpersonal/communication/influencing/negotiation skills/organization/prioritization.
- Must be well versed in validation disciplines, Equipment, Facilities, Critical Systems, Utilities, Computer Systems, Process and Materials.
- Strong knowledge of GMPs, FDA and EU guidelines/requirements, is required.
- Must have sound industry knowledge, project proficiency, and autonomy expected.
- Must be able to lead and implement optimization of processes within the department or the site.
- Must have advance experience and proficiency in problem analysis and resolution, successful track record of analyzing complex technical problems, and demonstrates good troubleshooting and decision-making abilities.
Education and/or experience
- Minimum of a BS or BA preferably in science or engineering (advanced degree preferred) or other job-related discipline.
- Minimum 8+ years related experience with 1+ year s leadership experience required.
- Experience in manufacturing processes and control systems (e.g. Allen-Bradley PLC, Delta V, BAS, Siemens), cleaning processes, process materials, process equipment, facilities and critical support systems are required.
- Prior experience interacting with the FDA and other regulatory agencies a must.
- Project management experience preferred.
- May be able to lift, push, pull and carry up to 25 lbs.
- In general, the position may require a combination of sedentary work and walking around observing conditions in the facility.
- Will work mostly in office environment with requirements to work in manufacturing and support areas.
- Will work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
- May work in a hot/cold, wet environment and climb up into large processing tanks.
- Will work in Cleanrooms, including cold/hot storage conditions.
- May work in a loud area that requires hearing protection and other protective equipment to be worn.
- Must have the ability to work in confined spaces (e.g. attic space, engine rooms and tanks).
- Will work around chemicals, such as alcohol, acids, buffers, and celite, that may require respiratory protection.
- Must be able to work multiple shifts, including weekends and extended hours, as required.
- 5% travel may be required to other Takeda facilities in order to manage projects related to these facilities or interact with other validation colleagues and/or as part of professional development.
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Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.