Validation Manager


Job ID 19-00050

Industry Pharma

Job Type Permanent

Location Somerset, NJ

Description

Job description
Validation Manager will provide expertise, guidance and oversight for the Validation efforts at our Somerset facility. Ensure the development and implementation of the Validation Department and the Site Validation Master Plan. Effectively oversee industry "best practices " using resources, such as ISPE and PDA and continuously upgrades the Site's validation practices and procedures. Manages site compliance with current FDA regulatory requirements and expertise to work with all levels of management, staff and internal departments including outside contractors and vendors, as applicable.

Essential Functions:

1. Provide expertise in the development, execution and review of validation protocols.
2. Develop and maintain a requalification schedule for facilities, equipment and processes based on a risk assessment, current industry "best practices, " and regulatory requirements.
3. Able to schedule staff to meet aggressive validation timelines.
4. Responsible for the maintenance and implementation of the Somerset Validation Master Plan Schedules, including facility, equipment and process requalification.
5. Excellent working knowledge of cGMP requirements on validation methods and principals including ISPE, GAMP guidelines and FDA, CFR Part 11 Electronic Records and Signatures requirements.
6. Able to hire, mentor and train staff and other resources as needed.
7. Able to develop and write applicable validation documentation, including, but limited to URSs, FDSs, DOEs, FATs, IQs, OQs, PQs, VQs from scratch/manuals, if not readily available.
8. Able to handle multiple, complex projects and work independently.



Qualifications

Qualifications:
Bachelor's Degree in Engineering, Chemistry or Microbiology required with preference for the Engineering Sciences
Minimum 5 years Pharmaceutical Manufacturing Validation experience required
Minimum 2 years formal supervisory experience required
Sterile/aseptic manufacturing experience required
Ability to operate and trouble shoot validation monitoring equipment
Ability to estimate and maintain project timelines