QAV Engineer

United Pharma Technologies Inc; Massachusetts; On-site; USD 51,000 - 73,000; Full time

Benefits offered by this job

Health Insurance

401(k) retirement plan

Job summary

United Pharma Technologies Inc is seeking an experienced QAV Engineer to support a pharmaceutical client in Boston, MA. The role focuses on quality assurance, equipment qualification, and validation within a GMP manufacturing environment, with a strong emphasis on CQV activities and cGxP compliance.

The engineer will lead CAPAs, execute IQ/OQ/PQ, review validation plans and reports, and collaborate with engineering and cross-functional teams to maintain GMP standards.

Qualifications

• Bachelor's degree in Engineering or Science required.
• 3+ years in GMP manufacturing facilities.
• Mandatory OSD experience.
• CQV experience for facilities, utilities, or equipment.
• Strong knowledge of validation lifecycle and cGxP.
• Experience with FDA, cGMP, ICH, ISO, EMA, ISPE, PDA guidelines.
• Excellent documentation and cross-functional collaboration.

Responsibilities

• Perform quality engineering activities and remediate GMP gaps.
• Lead and own CAPAs for quality and compliance issues.
• Execute installation verification, IQ/OQ/PQ and equipment qualification.
• Support validation for cold storage, autoclaves, and warehouse ops.
• Develop and review validation plans, SOPs, and reports.
• Review lifecycle docs: URS, risk assessments, traceability matrices.
• Investigate quality events related to qualified equipment.
• Assess change controls for validation impact and decommissioning.

Skills

QA/QC

GMP Compliance

Documentation

Cross-functional Collaboration

Education

Bachelor's degree in Engineering or Science

Tools

CQV

Regulatory Guidelines (FDA/cGXP)

Job description

Industry: Pharmaceutical / Biopharmaceutical

Job Description:

We are seeking an experienced QAV Engineer to support a pharmaceutical client in Boston, MA. The ideal candidate will have a strong background in Quality Assurance, equipment qualification, and validation within a GMP-regulated manufacturing environment.

Key Responsibilities:

• Perform quality engineering activities and remediate compliance gaps within GMP facilities.
• Initiate, manage, and own CAPAs to address quality and compliance issues.
• Execute installation verification, functional testing, equipment qualification, and performance qualification (PQ).
• Support validation activities for cold storage, autoclaves, and warehouse operations.
• Develop, execute, revise, and review validation protocols, plans, SOPs, and reports.
• Review lifecycle documentation, including URS, design documents, risk assessments, impact assessments, Part 11 assessments, and traceability matrices.
• Investigate and remediate quality events related to qualified equipment.
• Assess change controls for validation impact and support decommissioning activities.
• Review and approve validation plans, protocols, and reports.
• Collaborate with engineering teams, SMEs, and cross-functional stakeholders to maintain GMP compliance and documentation.

Required Qualifications:

• Bachelor’s degree in Engineering, Science, or a related discipline.
• Minimum 3 years of experience in GMP manufacturing facilities.
• Mandatory experience in Oral Solid Dosage (OSD).
• Hands-on experience with commissioning, qualification, and validation (CQV) of facilities, utilities, production, laboratory, or support equipment.
• Strong knowledge of validation lifecycle management, risk-based validation, and cGxP requirements.
• Experience with equipment qualification, process validation, computer systems validation, cleaning validation, or sterilization.
• Knowledge of FDA, cGMP, ICH, ISO, EMA, ISPE, and PDA guidelines.
• Strong communication, documentation, and cross-functional collaboration skills.

Pay Rate:$45/hr on W2

Employees hired into this position are eligible for the following benefits, subject to applicable plan terms and eligibility requirements:

Health Insurance:

Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits:

A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO):

No PTO is provided other than that required by applicable state and local laws.