Quality Assurance Engineering Lead

Quality Assurance Engineering Lead

Schedule: Monday–Friday, 8:30 AM–5:30 PM (flexibility with start/end times)
Contract: 1 year initially, with likely extension to 2 years

Position Overview

We are seeking an experienced Quality Assurance Engineering Lead to provide QA and GMP oversight for global engineering programs supporting pharmaceutical and biologics manufacturing. This role will partner with engineering, quality, and site teams to ensure facility, utility, and equipment designs meet GMP, regulatory, qualification, and contamination-control requirements.

Key Responsibilities

• Provide QA governance and GMP oversight for engineering projects involving biologics, API, aseptic manufacturing, drug product/drug substance, laboratories, and related systems.
• Provide QA guidance during facility, utility, and equipment design reviews and identify/mitigate GMP risks.
• Lead Contamination Control Strategy (CCS) development and contamination-control risk assessments.
• Lead cross-functional quality and GMP risk assessments and ensure appropriate mitigation actions.
• Participate in System Risk Assessments (SRA) and review qualification/validation documentation.
• Evaluate critical design elements and proposed qualification/test plans.
• Ensure compliance with applicable FDA, EMA/EMEA, and regional regulatory requirements.
• Apply Quality Risk Management principles, including ICH Q9 and risk-based qualification practices.
• Partner with site Quality, Engineering, Operations, and other stakeholders to deliver quality objectives and maintain project schedules.
• Communicate quality, GMP, and regulatory risks to project leadership and senior QA management.

Required Qualifications

• Bachelor's or Master's degree in Engineering, Science, Pharmaceutical Sciences, or a related discipline.
• 8+ years of experience in the pharmaceutical/biopharmaceutical industry within Quality Assurance, Engineering, Operations, Validation, or Technical Support.
• Strong experience with GMP, C&Q/CQV, facility/utilities/equipment qualification, and engineering design reviews.
• Experience with contamination control strategies and contamination-control risk assessments.
• Knowledge of aseptic manufacturing, fill-finish, biologics, API, drug substance/drug product, terminal sterilization, or pharmaceutical laboratories.
• Knowledge of FDA/EMA regulations and industry guidance such as ISPE and PDA.
• Experience with Quality Risk Management, ICH Q9, and risk-based qualification.
• Strong written and verbal communication skills, including the ability to present quality and regulatory risks to senior leadership.
• Ability to manage multiple priorities and work effectively in a fast-paced project environment.

Preferred Qualifications

• Experience with sterile/aseptic manufacturing or fill-finish operations.
• Experience developing or implementing a Contamination Control Strategy (CCS).
• Experience with ISPE Baseline Guide Volume 5.
• Experience supporting global engineering programs.
• Experience with QC/microbiology laboratory facilities and testing equipment.
• Experience in biologics drug substance/drug product or API manufacturing.

Pay: $38.00 - $40.00 per hour

Expected hours: 40.0 per week

Benefits:

• Flexible schedule

Education:

• Bachelor's (Preferred)

Experience:

• developing/implementing Contamination Control Strategy (CCS): 8 years (Preferred)
• CQV, facility/utilities/equipment qualification: 8 years (Preferred)
• biologics drug substance/drug product or API manufacturing: 8 years (Preferred)
• QA oversight for C&Q: 8 years (Preferred)
• pharma/biotech manufacturing or engineering,: 8 years (Preferred)

Ability to Commute:

• Barceloneta, PR 00617 (Preferred)

Work Location: In person