Sr. Quality Control Laboratory Engineer

The Senior Quality Control Laboratory Engineer will provide support for analytical method validation, including design, protocol, execution, and report. Will also collaborate with senior scientists and leadership on new methods and new equipment implementation and transfer of analytical methods to quality control routine operation through personnel training. Also, will be a key player in root cause investigations, CAPAs and OOS according to GLP, GMP, GDP and safety standards.

Essential Functions & Accountabilities:

• Lead and oversee qualification and validation activities for QC laboratory analytical equipment, ensuring adherence to timelines and validation schedules. Includes authoring protocols/reports and supervising execution with technicians.
• Design, develop, and validate laboratory test methods, ensuring robustness and compliance with regulatory standards.
• Manage laboratory equipment lifecycle, including establishing maintenance contracts, coordinating calibrations and repairs, maintaining asset tracking systems, and ensuring readiness for operations.
• Perform advanced troubleshooting and root cause analysis on equipment and processes, collaborating with technicians, engineers, and management to resolve non-conformances.
• Provide timely, data-driven technical feedback to QC and production teams to support decision-making and process improvements.
• Analyze laboratory data and trends to identify opportunities for continuous improvement and implement corrective actions.
• Collaborate cross-functionally to resolve technical issues and support manufacturing and quality initiatives.
• Review and approve laboratory reports for raw material and production batch release, ensuring accuracy and compliance.
• Serve as Subject Matter Expert (SME) during internal and external audits, representing QC laboratory operations.
• Lead complex projects and act as primary point of contact, driving communication and alignment across stakeholders.
• Partner with manufacturing engineering to transfer and implement QC methods and equipment from donor sites into production and QC labs.
• Support integration of relevant procedures into the Quality Management System, ensuring alignment with global standards.
• Conduct and document laboratory investigations, including OOS, NCMR, CAPA, out-of-tolerance, and environmental monitoring deviations.
• Ensure strict compliance with GMP, ISO, FDA, OSHA, and other applicable regulations.
• Perform additional tasks assigned by management, contributing to departmental and organizational goals.

Travel:

• Less than 10% travel requirement

Qualifications:

Knowledge, Skills, and Abilities:

• Experience with advanced laboratory equipment troubleshooting qualification and analytical method validation.
• Knowledge of aseptic or pharmaceutical manufacturing (preferred).
• Strong problem-solving and innovative thinking skills.
• Advanced English proficiency (oral and written).
• Solid understanding of statistics and probability.
• Proficient in Microsoft Office Suite.
• Hands-on, proactive approach.
• Skilled in negotiation with internal customers, subcontractors, suppliers, and manufacturers.
• Self-motivated, results-oriented, with strong decision-making and teamwork abilities.

Work Environment:

• Prolonged sitting in front of a computer

Experience:

• A minimum of 5 years of experience with quality control, equipment qualification and method validation (IQ, OQ, PQ) in Medical Devices industry.
• Experience in analytical method transfer is required.
• Experience with international compendiums such as USP, ACS, Ph.Eur, ASTM.

Education:

• Degree in chemistry, biomedical engineering, biotechnology, bioprocess engineering, chemical engineering or similar.