General Description:
Responsible for providing quality oversight for the qualification and validation activities for equipment, utilities, and facilities. This role will be responsible for drafting, reviewing and approving qualification protocols/reports and any associated documentation in support of CQV activities for a new facility. The Role also need to drive the validation activity close out.
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, Turnover Packages, SOP’s, specifications, traceability matrices, thermal mapping documents, and design documentation.
- Provide expertise and solutions to issues regarding CQV Lifecycle documentation in regards for applicable FDA/EMEA Regulations
- Support validation activities for project activities including review of validation documentation (FAT, SAT, URS, SDS, IQ, OQ, PQ) and attendance at validation activities.
- Provide support to enforce CQV guidelines, policies and procedures for equipment, analytical equipment, utilities, and facilities (Examples: Bioreactor, Incubator Chromatography Systems, harvest hold tank, washers, autoclaves, etc.)
- Main focus of this role will be to Qualify Clean Rooms. Past experience with balance reports, hepa filter certs, and all associated utilities and equipment.
- Employee will be required to work closely with Manufacturing, Validation, 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.
- Undertaking any other duties for any department within the business, which may be requested by the Manager, for which training and/or an explanation has been provided and understood.
Core Competencies, Knowledge, and Skill Requirements
- Scientific degree (ideally: pharmaceutical sciences, engineering, chemistry, or related discipline).
- Minimum of 5 years’ experience in validation, biological quality assurance and/or quality control in an FDA-regulated biotechnology or pharmaceutical company with progressive levels of responsibility.
- 1-3 years in a quality assurance or quality control role in an FDA-regulated company
- Strong knowledge of cGMP’s 21CFR parts 2010 & 211, knowledge of 21CFR600 – Biologics desirable.
- Demonstrated knowledge of ISPE Baseline Guide 5, ASTM E-2500, EU regulatory requirements, and GAMP 5 Validation Lifecycle.
- 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).
Significant Contacts
Manufacturing, Validation, Site Automation, Engineer, Quality Control, and Global Technical Operations (GTS) associates
