Quality Assurance Engineering Lead

Validation & Engineering Group, Inc.; Barceloneta (PR); On-site; USD 110,000 - 160,000; Full time

Job summary

Validation & Engineering Group, Inc. in Barceloneta, Puerto Rico, seeks a Quality Assurance Engineering Lead to oversee global engineering programs ensuring GMP compliance and product quality.

As a primary QA representative, you will lead contamination control strategies, reviews of facility design, and risk assessments with cross-functional teams across sites. This role demands a strong engineering or scientific background, 8+ years in pharma QA/engineering, and excellent communication to keep

Qualifications

• Bachelor/Masters in Engineering, or Science related discipline with experience in API, biomanufacturing, aseptic manufacturing, terminal sterilization, medical devices or QC/microbiology labs.
• 8+ years’ experience in the pharmaceutical industry in Quality Assurance, Engineering, Operations, or Technical Support.
• Ability to manage multiple tasks and deliver on quality/GMP elements while keeping the project on schedule.
• Knowledge of regulatory requirements and expectations for contamination control and GMP design.
• Knowledge of ISPE Baseline Guide Volume 5 and ICH Q9 for risk management and qualification.
• Self-directed, communicative, and able to work with key stakeholders in a fast-paced project environment.

Responsibilities

• Provide QA governance and oversight for global engineering programs including biologics, API, aseptic manufacturing, and medical devices.
• Provide QA guidance at facility, utility and equipment design reviews and GMP reviews from concept to detailed design, ensuring mitigation of risks.
• Lead contamination control risk assessments with cross-functional teams to ensure GMP compliance and risk mitigation by design.
• Lead development of initial contamination control strategy for global programs at Sites.
• Make key GMP/quality decisions for facility, utility and equipment designs and report regulatory/compliance risks to the project lead.
• Participate in system risk assessments and review qualification documents in line with risk-based qualification requirements.
• Collaborate with site quality and cross-functional teams to deliver GMP/quality risk mitigation across programs.
• Apply knowledge of aseptic manufacturing, terminal sterilization, API and biologics GMP requirements.

Skills

Quality Assurance

GMP

Risk Management

Regulatory Compliance

Contamination Control

Cross-functional Leadership

Education

Bachelor/Masters in Engineering or Science

Job description

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.