General Description :

　　Responsible for providing oversight for the qualification and validation activities for computer systems, automated manufacturing equipment, and enterprise systems supporting large molecule clinical and commercial manufacturing, QC, and warehouse operations. This role will be responsible for reviewing and approving qualification protocols, reports and any associated documentation in support of computer systems validation, automated equipment, and data integrity for computerized systems as well as non-computerized systems.

　　Works to support Key Performance Indicators (KPIs) such as SOP mandated cycle times, on time closure dates, and objectives, whilst adhering to regulatory compliance and achieving business success. Creates and/or reviews SOPs needed to support the business. Works to support both internal GMP audits and Health Authority audits. Ensure the efficient and effective day to day running of the Validation area. Supports Validation related tasks as assigned by Management.

　　Essential Functions of the job:

　　Assist in development, review, and approval of cGMP documents including, but not limited to: Master Validation Plans, FAT/SAT documents, SOP’s, specifications, design documentation, and validation protocols/reports.

　　Provide expertise and solutions to issues regarding 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.

　　Support validation activities for project activities including review of validation documentation (FAT, SAT, URS, SDS, IQ, OQ, PQ) and attendance at validation activities.

　　Ensuring that the Validation department meets or improves key performance indicators (KPIs).Works to ensure assigned projects are on time, on budget, and have the required support.

　　Provide support to enforce CSV guidelines, policies, and procedures for DCS, analytical equipment, and IT applications (Examples: OSI PI, SCADA, EMS, Chromatography Systems, Empower, Single-Use Bioreactors, ViCell, HPLCs).

　　Employee will be required to work closely with Manufacturing, Site Automation, Engineer, Quality Control, and Global Technical Operations (GTS) associates.

　　Ensuring appropriate investigation of validation discrepancies, errors, protocol failures, or validation testing errors requiring documented review and action to reconcile deviations.

　　Ensuring the business stays current on new technology, validation techniques, and risk-based approaches.

　　Undertaking any other duties for any department within the business, which may be requested by the CSV Senior Engineer, for which training and/or an explanation has been provided and understood.

　　Core Competencies, Knowledge and Skill Requirements

　　Bachelor’s of Science degree (ideally: pharmaceutical sciences, engineering, chemistry, or related discipline).

　　Minimum of 5 years’ experience in validation, computer systems and/or computer validation in an FDA-regulated biotechnology or pharmaceutical company with progressive levels of responsibility.

　　Working knowledge of cGMP’s 21CFR parts 2010 & 211, knowledge of 21CFR600 – Biologics desirable.

　　Strong knowledge of GxP compliance as it applies to Computer Systems, 21 CFR Part 11, GAMP 5 Validation Lifecycle. Knowledge of cGMP and Data Integrity Guidance utilized in a Quality Operation.

　　Knowledgeable in risk assessments and process for following well documented and thought through risk-based approaches.

　　Demonstrable track record and skills/experience gained within a similar position(s), at a similar level.

　　Good collaboration and good project management skills.

　　Credible and confident communicator (written and verbal) at all levels.

　　Customer focused, Strong analytical and problem-solving ability.

　　Hands-on approach, with a ‘can do’ attitude. Able to work under minimal supervisor.

　　Ability to prioritize, demonstrating good time management skills.

　　Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.

　　Self-motivated, with the ability to work proactively using own initiative.

　　Committed to learning and development.

　　Highly Desirable: Good IT skills e.g., Microsoft Office (Word, Excel, PowerPoint, Project, and Outlook); working knowledge of SAP.

　　Computer Skills:

　　MSOffice skills (Outlook, Word, Excel, PowerPoint); knowledge of SAP QM moduleOther Qualifications: N/A

　　Travel:

　　Must be willing to travel approximately 5-10%All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.