Essential Duties and Responsibilities
- This position will provide extensive knowledge and leadership in validation strategy to the site and global projects and
- This position will have engineering validation oversight and engineering validation signatory responsibility for approval of commissioning, qualification / validation, and final report documents.
- This position is responsible for assess, qualify and validate equipment, critical systems (utilities), facilities, computer system, cleaning and manufacturing processes, and process materials, 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.
- Applies thorough understanding of cGXPs, GAMP5 and 21CFR Part 11 (as applicable), relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.
- Performs a variety of projects/studies in several areas at the same time to support manufacturing and engineering.
- Responsible for planning, scheduling, and leading validation assignments. 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.
- Provides training, mentoring and leadership to less experienced staff.
- Handles routine tasks with attention to detail, timely and accurately.
- 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 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 Guidelines), procedures, and regulatory requirements such as but not limited to (21 CFR Parts 210, 211, 600, ISO 14644, EC-Annex1, 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 Global Validation procedures. Drive and close compliance gaps as they are identified.
- Perform update 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.
- Participate in internal or external assessments or audits, as required. Support process with timely closure of observations/audit items.
- Applies solid understanding of theories/practices utilized by other disciplines outside the primary area of expertise toward the development of validation strategies and qualification requirements.
- 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 as needed to meet project timelines, goals and milestones.
- Monitor and report validation costs including capital and cross-functional expenses.
- Lead and participate in the drafting and implementation of Global Validation procedures including initiatives for harmonization and streamlining efforts.
- Use of validation test equipment, such as, Kaye Validator and Ellabs loggers in support of validation activities.
- Perform other duties as directed by supervisor.
Education and/or experience
- Must have experience, proficiency, and leadership in pharmaceutical/biotech validation elements, including the writing and executing of protocols and standard operating procedures.
- Must be proficient in more than one validation element.
- 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 have extensive cross-functional team experience.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 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 sound industry knowledge, project proficiency, and autonomy expected.
- Must be able to lead and implement optimization of processes within the department or the site.
- Should 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.
- Ability to organize and present technical and project management overviews without assistance to upper-management.
- Minimum of a BS or BA preferably in science or engineering (advanced degree preferred) or other job-related discipline.
- Minimum 7+ years related experience or 6+ years related experience with an advanced degree.
- 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.
- 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.
- 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.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.