This position will provide guidance in validation strategy to the site and global projects. The position will have engineering validation signatory responsibility for approval of commissioning, qualification / validation protocols and final report documents. This position is responsible for assess, qualify and validate equipment, critical systems (utilities), facilities, computer system, and cleaning, as applicable.
Primary tasks include development of protocols, coordination of validation activities, qualification/validation execution, preparing final reports and assembly of final validation packages; generation of project plans. Responsibilities will consist of both initial validation efforts as well as revalidation. Additionally, investigations of manufacturing challenges are conducted and process improvements are evaluated and implemented. Final documents are archived and may be included in or support regulatory submissions, and made available as needed during internal and external regulatory/compliance audits. This position will provide interpretation of regulatory requirements.
This position will work in close cooperation with the manufacturing business units, Engineering, Regulatory, QC, and Quality Operations on a day-to-day basis.
Essential Duties and Responsibilities
- Applies thorough understanding of cGXPs, GAMP5 and 21CFR Part 11 (as applicable), relevant SOP curriculum, routine project procedures, and other training as appropriate.
- Performs a variety of projects/studies in several areas at the same time to support manufacturing and engineering.
- Handles projects that are more complex and broad in scope, which require team leadership and task prioritization. Must demonstrate competent and effective planning, coordination, and organizational skills.
- Review and asses change control requests with potential impact to validated state of validation elements, as applicable.
- Handles routine tasks with attention to detail, timely and accurately.
- Participate and interface with cross-functional project 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 accuracy and integrity on validation documentation meets regulatory guidelines and industry standards.
- Write protocols and reports, execute, interpret, and evaluate validation documents in terms of acceptability to industry standards (GMPs, FDA, EU and JP Guidelines), procedures, and regulatory requirements such as but not limited to (21 CFR Parts 210, 211, 600, ISO 14644, EC-Annex1, USP-NF, etc.).
- 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.
- Utilize Quality-Engineering tools to problem solve/troubleshoot and assist in risk analysis (e.g., FMEA, Design of Experiments, QbD, SPC).
- Must be able to identify opportunities for optimization processes within the department or the site.
- Identify gaps related to validation requirements and validation procedures. May drive and close compliance gaps as they are identified.
- Perform updates to element validation assessments and validation plans, as required.
- Assist / support, as required, in the investigation and closure of non-conformances/events, corrective actions and preventative actions.
- May participate in the generation and updating of standard operating procedures based on operations and validations to meet divisional and regulatory requirements.
- Participate in internal and/or external assessments and/or audits, as required. Support process with timely closure of observations/audit items.
- Assist with regulatory agency inspections, including interfacing with inspectors and corporate/division/internal auditors. Present validation strategy and protocols in regulatory inspections.
- Use of validation test equipment, such as, Kaye Validator and Ellabs loggers in support of validation activities.
- Perform other duties as directed by supervisor.
- Must have experience and proficiency in pharmaceutical/biotech validation elements, as applicable, including the writing and executing of protocols and standard operating procedures.
- Must have a strong comprehension of the operating principles in a cGMP regulated environment. Hands-on Manufacturing, Engineering and/or Technical Service experience is a plus.
- Must be able to work independently and as part of a team. Must also have demonstrated ability to produce results in a cross-functional team environment (including technical and non-technical work) with minimal supervision.
- Must demonstrate leadership skills.
- Must possess excellent technical writing, communication, and organizational skills.
- Must display a solid technical understanding of Quality Engineering of the validation element principles and procedures and scheduling a series of project technical and project management overviews without assistance.
- Must be proficient with Microsoft Office including MS Word, Excel, Power Point, Visio and Project.
- Must have the ability to prioritize multiple projects and manage time efficiently in order to meet established timelines.
- Ability to communicate effectively at all levels in verbal (soft skills) and written form, including technical/business writing.
- Must be able to identify opportunities for optimization of processes within the department or the site.
- Should have experience in problem analysis and resolution.
Education and/or experience
- Typically requires BA or BS degree preferably in the engineering or science field.
- Minimum 4+ years validation experience.
- 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, as applicable.
- 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.
- Must have the ability to work in confined spaces (e.g. attic space, engine rooms and tanks).
- May work in a loud area that requires hearing protection and other protective equipment to be worn.
- 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.
- 2% travel may be required to other Shire facilities in order to manage projects related to these facilities or interact with other validation colleagues and/or as part of professional development.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
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.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
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.