Quality Engineer III

Title: Quality Assurance Engineering Lead
Location : Barceloneta PR
Duration : 12+ Months
Pay Range: $35/hr - $39/hr

Purpose:
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 Client 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 Client 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 Client 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 Client 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/master s 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

Top Skills:

• QA for C&Q including facilities, utilities, equipment including aseptic fill finish and BDS

• Knowledgeable on lab facility and testing equipment requirements (C&Q knowledge desirable here also)

• Knowledgeable on Contamination control strategy and contamination control risk assessments including ability to lead risk assessment execution

• Knowledgeable on applicable regulations as defined by FDA, EMA etc and industry guidance and best practise eg ISPE, PDA

• Communication skill and presetting to senior QA leadership

Monday to Friday 830-530PM Flexibility for start and finish time