Validation Supervisor

Job Details:

Role:

Validation Supervisor Location:

Fall River, MA -

Onsite Duration:

Full Time Experience:

5 - 15

Years Job Description:

Must:

• Bachelor's degree in Engineering (Mechanical, Electrical, or related field); Master's preferred.
• Atleast 5 years of experience in pharmaceutical or biotech engineering and validation project management.
• Protocol authorship —

IQ/OQ/PQ

(lead, not support)Must have written validation protocols independently, not just reviewed or assisted. Execution experience is equally mandatory.

• Sterile manufacturing process knowledgeMust understand the manufacturing process for vials, PFS, or IV bags — this directly drives what gets validated and how
• Change control + deviation + CAPA management.

Must have raised, tracked, and closed change controls and deviations in a cGMP environment — audit-facing experience is critical Nice to

Have:

PMP certification is a plus

Pay:

$76,000.00 - $100,000.00 per year

Benefits:

401(k) Health insurance Paid time off Relocation assistance Application Question(s): Have you written validation protocols independently? How many

IQ/OQ/PQ

protocols have you written independently? Tell me about a validation project where something failed during execution. How did you handle the deviation and what did the CAPA look like? Have you worked on validation of sterile manufacturing equipment — filling lines, isolators, autoclaves, lyophilizers, or similar? Have you supported an FDA inspection or internal audit where your validation documentation was reviewed? What was the outcome? Have you raised and managed change controls for equipment or process changes in a cGMP facility?

• Please do share the best time to reach you + your preferred e-mail + number.

Education:

Bachelor's (Required)

Experience:

pharmaceutical / biotech: 5 years (Required)

IQ/OQ/PQ

5 years (Required) vials / PFS / IV bags: 5 years (Required)

CAPA :

5 years (Required)

Validation Supervisor :

5 years (Required)

License/Certification:

PMP (Preferred)

Work Location:

In person