Pharma QAV Engineer - GMP Validation & Compliance Lead

DPS Group Global; Boston (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Arcadis is seeking an experienced QAV Engineer to support a pharmaceutical client in the Boston area. You will contribute to quality engineering activities across qualification, validation, and remediation within GMP environments.

Ideal candidates have a Bachelor’s degree in Engineering or Science, 3+ years in GMP manufacturing, and hands-on experience with IQ/OQ/PQ, CAPAs, change control, and regulatory guidance (FDA, cGxP).

Qualifications

• Bachelor’s degree or equivalent in Engineering, Science, or related discipline.
• 3+ years of experience working in a GMP manufacturing facilities role.
• Must have Oral Solid dosage expeience.
• Experience in pharmaceutical or biopharmaceutical/biotechnology cGxP environment.
• Combination of equipment qualification, process validation, computer systems, cleaning, and sterilization is acceptable. QA pharmaceutical experience is also preferred.
• 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.
• Experience working in cell and gene therapy products is a plus.
• 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.

Responsibilities

• Quality Engineering in the Pharmaceutical and/or Bio Pharmaceutical industries.
• Compliance review remediation to identified gaps.
• Initiate and Own CAPA’s to remediate gaps.
• Installation Verification, Functional Testing and Performance Qualifications (PQs).
• Ensure all aspects of cold storage, autoclave and warehouse validation adhere to required policies and procedures, including safety and training.
• Generate and execute validation protocols and assessments from a quality system documentation perspective for cold storage, autoclave and warehouse operations.
• Revision of Qualification and Validation life cycle documents.
• Assist in the investigation and remediation of Quality Events related to qualified equipment.
• Review lifecycle documents such as Impact Assessments, User Requirements, Design Documents, Risk Traceability Matrix, Criticality Assessments, Risk Assessments, Part 11 Assessments, etc.
• Review and Approve Validation plans, protocols, and reports.
• Assess Change Controls for Validation Impact.
• Collaborates with stakeholders, engineers, SMEs, and cross-functional team members in equipment qualification efforts.
• Participates in continuous improvement and validation maintenance efforts of GMP Documentation, including Batch Records.

Skills

Quality Engineering

CAPA management

Validation (IQ/OQ/PQ)

GMP compliance

Cross-functional collaboration

cGxP knowledge

Equipment qualification

Auditing

Documentation

Communication

Education

Bachelor's degree in Engineering or Science

Job description

Arcadis is seeking an experienced QAV Engineer to support a pharmaceutical client in the Boston area. You will contribute to quality engineering activities across qualification, validation, and remediation within GMP environments.

Ideal candidates have a Bachelor’s degree in Engineering or Science, 3+ years in GMP manufacturing, and hands-on experience with IQ/OQ/PQ, CAPAs, change control, and regulatory guidance (FDA, cGxP).