Senior CQV Validation Engineer – GMP Biotech CDMO

Initial Therapeutics, Inc.; Pennington (NJ); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan with company match

Paid parental leave

Flexible spending accounts

Job summary

Initial Therapeutics, Inc. is looking for a Validation Specialist in Pennington, New Jersey to support commissioning, qualification, and validation (CQV) activities in a GMP manufacturing setting. The ideal candidate will have 9 years of experience in the drug/biologics industry, particularly within biotechnology and pharmaceutical facilities.

The role involves documenting validation protocols, facilitating technology transfers, and ensuring compliance with regulatory requirements. Benefits include comprehensive health insurance and a supportive work culture.

Qualifications

• 9 years of experience in drug/biologics industry in GMP production environment.
• Working experience in CQV for biotechnology/pharmaceutical facility.
• Familiar with CSV according to GAMP 5 and CFR Part 11.

Responsibilities

• Execute commissioning, qualification, and validation (CQV) activities for facilities.
• Develop, review, and execute IQ, OQ, PQ protocols and validation reports.
• Support technology transfer and startup activities for new client manufacturing programs.

Skills

CQV for biotechnology/pharmaceutical facility

Ability to work across functional groups

Familiar with GMP operational principles

Experience in aseptic fill/finish equipment qualification

Education

BS/MS in life science or related field

Job description

Initial Therapeutics, Inc. is looking for a Validation Specialist in Pennington, New Jersey to support commissioning, qualification, and validation (CQV) activities in a GMP manufacturing setting. The ideal candidate will have 9 years of experience in the drug/biologics industry, particularly within biotechnology and pharmaceutical facilities.

The role involves documenting validation protocols, facilitating technology transfers, and ensuring compliance with regulatory requirements. Benefits include comprehensive health insurance and a supportive work culture.