Validation Engineer II — GMP CQV Specialist

Initial Therapeutics, Inc.; Norwood (MA); On-site; USD 72,500 - 116,000; Full time

Benefits offered by this job

Best-in-class healthcare coverage

Holistic well-being programs

Generous paid time off

Job summary

A leading biotechnology firm in Norwood is seeking a Validation Specialist to execute qualification activities in compliance with industry standards. The successful candidate will perform commissioning and validation at a GMP manufacturing facility, ensuring all processes are in compliance. A degree in Life Science or Engineering is required, along with 2+ years of industry experience. This role offers competitive benefits and a holistic approach to well-being, fostering an environment of innovation and teamwork.

Qualifications

• Minimum 2+ years in commissioning, qualification, or validation experience in cGMP.
• Strong understanding of validation principles and regulatory requirements.

Responsibilities

• Perform qualification activities as per CQV program.
• Ensure compliance of systems and equipment.
• Support internal and external audits as part of CQV.

Skills

Commissioning

Qualification

Validation

Quality documentation generation

Interpersonal skills

Education

B.S. in Life Science or Engineering

Master’s degree in relevant field preferred

Job description

A leading biotechnology firm in Norwood is seeking a Validation Specialist to execute qualification activities in compliance with industry standards. The successful candidate will perform commissioning and validation at a GMP manufacturing facility, ensuring all processes are in compliance. A degree in Life Science or Engineering is required, along with 2+ years of industry experience. This role offers competitive benefits and a holistic approach to well-being, fostering an environment of innovation and teamwork.