Quality Assurance Engineering Lead

Validation & Engineering Group; Barceloneta (PR); On-site; USD 130,000 - 170,000; Full time

Job summary

Validation & Engineering Group is seeking a Quality Assurance Engineering Lead to oversee QA for global engineering programs, including biologics, aseptic manufacturing, and medical devices. The role ensures GMP compliance and risk mitigation across design and qualification lifecycles.

The ideal candidate will guide design reviews, participate in SRAs, and coordinate with site quality teams to maintain schedules and quality deliverables in a fast-paced environment.

Qualifications

• Bachelor’s or Master’s in Engineering or Science required.
• 8+ years in Quality Assurance Engineering or related pharma roles.
• Strong GMP knowledge and ability to manage design and qualification activities.

Responsibilities

• Provide QA governance and oversight for global engineering programs.
• Review facility utility and equipment design through GMP qualifications.
• Lead contamination control risk assessments across sites and functions.
• Develop contamination control strategies for global engineering programs.

Skills

Quality Assurance

Regulatory Compliance

GMP Knowledge

Cross-functional Collaboration

Communication Skills

Project Oversight

Education

Bachelor’s or Master’s in Engineering or Science

Tools

GMP Documentation

Risk Management

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

Responsibilities

Provide quality assurance governance and oversight for global engineering programs which may include projects related to biologics drug substancedrug product API aseptic manufacturing terminally sterilized products medical devices andor laboratoriesProvide 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 lifecycleEnsure the risks identified are mitigated during design phaseLead 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 designLead the development of the initial contamination control strategy for global engineering programs at SitesMake 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 registerParticipate 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 equipmentEstablish relationships and collaborate with site quality team members and cross functional team members to achieve quality deliverables including GMPquality risk mitigation for global engineering programs

Qualifications

BachelorMasters 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 QCmicrobiology laboratories8 years experience in the pharmaceutical industry in Quality Assurance Engineering Operations or Technical SupportPossesses 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 qualityGMP elements ensuring project remains on scheduleA strong quality assurance mindset with knowledge and experience in either; quality assurance engineering operations or technical area with a comprehensive understanding of biological andor pharmaceutical technologiesKnowledge of pharmaceutical regulatory requirements and expectations supporting contamination control and GMP design requirementsKnowledge and experience with risk based qualification ISPE Baseline Guide Volume 5 Commissioning and Qualification and quality risk management ICH Q9Self directed self motivated with an ability to represent the quality function in a high paced project environmentAbility to work closely with key project stakeholders to maintain project delivery schedules and limit any potential delaysExcellent 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

Company Culture

At Validation & Engineering Group people always come first We believe that when youre empowered to do your best work bold ideas thrive and real progress happens This isnt just a job its an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose driven supportive team Excited to build something meaningful together We look forward to hearing from you 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