Scientist II or III - Metrology Specialist - FSP

Responsibilities

• Oversee the lifecycle of regulated and non-regulated laboratory equipment, including acquisition, installation, and retirement
• Prepare, review, and approve instrument documentation such as master equipment lists, qualification, and calibration records
• Coordinate service activities with vendors and service engineers to maintain strong working relationships
• Perform or facilitate troubleshooting, maintenance, and calibration of laboratory instrumentation
• Participate in computer system validation (CSV) activities for new or upgraded equipment and software
• Support the purchase and qualification of new laboratory equipment
• Manage Change Management (CM) and Notice of Event (NOE) records
• Perform and document investigations and assist in developing CAPA plans
• Represent the laboratory during regulatory audits to ensure compliance with cGMP and internal policies

Requirements

• B.S. or M.S. in Chemistry, Biochemistry, Engineering, or a related scientific discipline
• Experience working within a regulated (GMP) laboratory environment
• Proficiency in maintaining, operating, and troubleshooting equipment including HPLC, GC, and UV-Vis
• Knowledge of standalone computer system GMP validation requirements
• Strong verbal and written communication skills with experience authoring SOPs
• Ability to work independently under moderate supervision and manage multiple schedules/tasks

Preferred Qualifications

• Experience with dissolution systems and other specialized computerized laboratory systems
• Proven ability to collaborate effectively with both on-site and off-site technical collaborators

Benefits

• Full benefits package
• 401K options
• Paid holidays and paid time off (PTO)
• Sick time

About the Company

Parexel FSP provides pharmaceutical and biopharmaceutical companies with highly qualified technical professionals to support the development and delivery of life-changing new therapies. Our mission is to keep patients at the center of everything we do.