We are seeking an experienced QAV Engineer to collaborate with a pharmaceutical client in the Norwood, MA region. Strong comprehension of the engineering lifecycle associated with biotech and pharmaceutical GMP industries is essential for ideal candidates.

Key Responsibilities:-

Collaborate with a pharmaceutical client in the Norwood, MA region.

Utilize strong comprehension of the engineering lifecycle associated with biotech and pharmaceutical GMP industries.

Ensure quality assurance and validation activities are conducted in accordance with regulations and guidelines.

Develop and execute validation protocols for equipment, utilities, and systems.

Conduct and document risk assessments and gap analyses.

Review and approve documentation, including standard operating procedures, batch records, and validation reports.

Participate in investigations and root cause analyses of deviations and non-conformances.

Provide guidance and support to internal and external stakeholders on quality and compliance matters.

Skills & Qualifications

Bachelor’s degree or equivalent in Engineering, Science, or related discipline

3+ years of experience working in a GMP manufacturing facilities role.

Experience working in cell and gene therapy products is a plus.

Experience in pharmaceutical or biopharmaceutical/biotechnology cGxP environment.

Quality experience with in-depth knowledge of Validation approach, cGxP standards, and Risk-based validation.

Must have direct experience in the commissioning, qualification, and validation of facilities, utilities, production, laboratory, and support equipment.

Combination of equipment qualification, process validation, computer systems, cleaning, and sterilization is acceptable. QA pharmaceutical experience is also preferred.

Knowledge of Industry guidelines (ISPE, PDA) US and international regulations (FDA, cGMP, ICH, ISO, EMA) for validation of GMP facilities.

Must have strong verbal, written, and interpersonal communication skills especially needed to work in a cross-functional environment.

Job Types: Full-time, Contract

Pay: $48.00 per hour

Experience level:

• 5 years

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Norwood, MA 02062: Reliably commute or planning to relocate before starting work (Required)

Experience:

• CGMP: 3 years (Required)

Work Location: In person

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