Quality Assurance Validation (QAV) Consultant

PM Group is seeking a QAV Engineer in Raritan, NJ to Provide QA oversight of commissioning, qualification, and validation activities. This is an OTS role and will be reporting to the client site.

PM Group is an employee owned, international project delivery firm with a team of 3,600 people.  We are world leaders in the pharma, food, biotech, medical technology and mission critical sectors. From our network of offices in Europe, Asia and the US, we work with the world's leading organizations.  We are focused on growing a sustainable business centered on our people, our clients and trade partners.

• Provide QA oversight of commissioning, qualification, and validation activities
• Responsible for managing the review/approval of design and commissioning documentation, validation protocols (including associated discrepancies), reports and support records to certify compliance with specifications and procedures; ensures timely resolution of documentation, compliance, and quality system issues
• Support review and approval of validation related documentation; including but not limited to: IA, URS, DQ, ERES, CDS/FRS, FMECA, IOQ
• Reviews and assists in investigating discrepancies/deviations related to manufacturing process equipment, utilities, automation, computer systems, validation, methods, and laboratory instruments
• Responsible for performing change control assessments and reviewing/approving change control implementation plans for process, equipment, utilities, method, and computer system validation
• Participate in cross functional meetings for planning and discussing changes to be commissioned, qualified, validated equipment/facilities/utilities
• Participates in continuous quality system improvements and supports implementing improvements in the GMP Validation and Change Control Programs
• Use critical thinking skills to partner with CQV and facility engineers to problem solve
• Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements
• Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions
• Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections
• Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence
• Other duties as assigned

• Bachelor’s degree is required; an engineering degree is preferred
• 5-10 Years of CQV experience in the Pharmaceutical, Life Sciences, Biotech and/or Cell & Gene Therapy industries 
• 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 on large capital projects 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.
• Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation

All of your information is confidential according to EEO guidelines.

Why PM Group?

As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are the heart of our new 2025 business strategy. Click here to read more in our Corporate Responsibility and Heath, Safety & Well-being Report 2022.

Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future.

PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know.

RECRUITMENT AGENCIES NEED NOT APPLY

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