Quality Assurance Engineering Lead

Pinnaql, Inc.; Barceloneta (PR); On-site; USD 120,000 - 180,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a Quality Assurance Engineering Lead to drive QA oversight across global engineering programs, including biologics, API and aseptic manufacturing.

You will collaborate with site and cross-functional teams to uphold GMP requirements, lead contamination control strategies, and guide design reviews from concept through detail phases, ensuring regulatory compliance and timely delivery.

Qualifications

• 8+ years in the pharmaceutical industry in Quality Assurance, Engineering, Operations, or Technical Support.
• Bachelor/Masters in Engineering, or Science related discipline.
• Strong ability to manage multiple tasks and deliver on quality/GMP elements.
• Knowledge of FDA/EMEA regulations and contamination control.
• Experience with ISPE Baseline Guide Volume 5 and ICH Q9.
• Self-directed, motivated, able to represent QA in a fast-paced project environment.
• Excellent communication skills, both written and verbal.

Responsibilities

• Provide QA governance and oversight for global engineering programs (biologics, API, aseptic manufacturing, MDR and labs).
• Provide QA guidance at facility, utility and equipment design reviews and GMP reviews from concept to detail design, mitigating risks.
• Lead contamination control risk assessments with cross-functional teams to ensure GMP compliance.
• Develop initial contamination control strategy for global programs at sites.
• Decide GMP and quality requirements for designs and report regulatory/quality risks to the project risk register.
• Participate in SRAs and review qualification documents per risk-based qualification requirements.
• Collaborate with site quality and cross-functional teams to achieve GMP deliverables.
• Maintain knowledge of aseptic manufacturing, terminal sterilization, API and biologics GMP requirements.
• Stay informed on FDA/EMEA/regional health authority expectations.
• Apply Quality Risk Management and ISPE/ICH guidelines.

Skills

Quality Assurance

Engineering

GMP

Regulatory compliance

Risk management

Biologics

Aseptic manufacturing

Project management

Communication skills

Education

Bachelor's or Master's in Engineering/Science

Job description

Current job opportunities are posted here as they become available.

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Quality Assurance Engineering Lead

Description:

Responsible for the quality assurance oversight of global engineering programs which may include projects related to biologics (drug substance/drug product), API, aseptic manufacturing, terminally sterilized products, medical devices and laboratories, ensuring quality and GMP requirements are met.

As a member of the global engineering project team, the candidate will act as primary quality representative for key global engineering programs and collaborate with site and engineering cross functional teams, ensuring the principles of GMP and contamination control are upheld.

Responsibilities:

• Provide quality assurance governance and oversight for global engineering programs which may include projects related to biologics (drug substance/drug product), API, aseptic manufacturing, terminally sterilized products, medical devices and/or laboratories.
• Provide quality assurance guidance at facility, utility and equipment design reviews and GMP reviews from concept design phase and continuously throughout detail design phase of the engineering lifecycle. Ensure the risks identified are mitigated during design phase.
• Lead contamination control risk assessments with a cross functional team from sites and global functional groups ensuring GMP regulatory compliance and contamination risks are identified, evaluated and mitigated by design.
• Lead the development of the initial contamination control strategy for global engineering programs at Sites.
• Make key decisions regarding GMP and quality requirements for facility, utility and equipment designs ensuring potential regulatory compliance and potential contamination risks which have been identified are mitigated for during design phase. As a member of the project team, provide update to the project lead on regulatory compliance risks and quality risks to be included and monitored in the project risk register.
• Participate in system risk assessments (SRAs) and review of qualification documents (as required) in compliance with risk-based qualification requirements throughout the project lifecycle. Determine the critical design elements impacting product quality and assess the proposed test plan to qualify the facility, utility or equipment.
• Establish relationships and collaborate with site quality team members and cross functional team members to achieve quality deliverables including GMP/quality risk mitigation for global engineering programs.
• Knowledge of the principles and concepts applicable to aspects of aseptic manufacturing, terminal sterilization, API and biologics (DS/DP), and the associated facility, equipment and utility GMP requirements.
• Knowledge of applicable regulations as defined by FDA, EMEA and regional ministry of health.
• Knowledge of Quality Risk Management and contamination control strategies.

Qualifications:

• Bachelor/Masters in Engineering, or Science related discipline with relevant experience within some or all of the following; API, biomanufacturing, aseptic manufacturing, terminal sterilization, medical device and QC/microbiology laboratories.
• 8+ years’ experience in the pharmaceutical industry in Quality Assurance, Engineering, Operations, or Technical Support.
• Possesses knowledge and a skillset to operate within an environment that requires a high degree of urgency and task flexibility, ability to manage multiple tasks and deliver on quality/GMP elements ensuring project remains on schedule.
• A strong quality assurance mindset with knowledge and experience in either; quality assurance, engineering, operations, or technical area with a comprehensive understanding of biological and/or pharmaceutical technologies.
• Knowledge of pharmaceutical regulatory requirements and expectations supporting contamination control and GMP design requirements.
• Knowledge and experience with risk-based qualification (ISPE Baseline Guide Volume 5: Commissioning and Qualification) and quality risk management (ICH Q9).
• Self-directed, self-motivated with an ability to represent the quality function in a high paced project environment.
• Ability to work closely with key project stakeholders to maintain project delivery schedules and limit any potential delays.
• Excellent communication skills are required, as is the ability to communicate well, both verbally and written.
• Available to work extended hours, possibility of weekends and holidays.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.