Metrology Manager

PSC Biotech • York, PA

6d

About The Position

BioTechnique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fill -finish services. From IND applications through commercial scale production, we provide formulation and compounding, fill -finish, and lyophilization services for a wide variety of liquid injectables. BioTechnique utilizes our team’s expertise to create a process design for our clients’ products that best suits their needs. The Experience With operations spanning the globe and featuring a multi -cultural team, BioTechnique is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered a compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At BioTechnique, it’s about more than just a job—it’s about your career and your future. Your Role We are seeking an experienced Metrology Manager to support BioTechnique’s CDMO operations in York, Pennsylvania. This role is responsible for overseeing and performing calibration activities for facility, laboratory, and manufacturing instrumentation, ensuring measurement accuracy, reliability, and regulatory compliance within a pharmaceutical manufacturing environment. The ideal candidate will have a strong background in metrology, calibration, and GMP manufacturing processes, with hands -on experience performing calibrations related to temperature, humidity, pressure, mass, and light. The Metrology Manager will manage day -to -day activities for 2 of 6 metrology personnel supporting BioTechnique projects and equipment, and will play a critical role in maintaining product quality and compliance. Successful candidates demonstrate exceptional attention to detail, strong reading comprehension skills, and the ability to perform physical work for extended periods as required.

Requirements

• Bachelor’s degree or higher, preferably in Physics, Computer Science, Engineering, Chemistry, biology, microbiology, or other science or engineering related field, or equivalent experience.
• Minimum 8 -10 years of relevant metrology and management experience. Experience selecting and implementing metrology and or automated systems is required.
• Certification in metrology or calibration (e.g., ASQ Certified Calibration Technician).
• Experience with Lean Six Sigma or other process improvement methodologies.
• Demonstrates excellent verbal, written, and interpersonal communication skills.
• Demonstrate skills to plan, organize, analyze, and resolve problems.
• Experience deploying new metrology and novel systems in a manufacturing setting.
• Working knowledge of FDA and EU cGMP regulations and guidelines.
• Experience with evaluation of metrology through GR&R and MSA.
• Experience with new supplier evaluation and selection.
• Experience with change management in a manufacturing environment.
• Strong time management skills to manage multiple priorities.
• Strong influence and collaboration skills to develop global standards.
• Proficient in Microsoft Office Application
• Must be authorized to work in the U.S.
• No C2C at this time.

Responsibilities

• Manage the Metrology department at BioTechnique, including site and customer priorities, calibration scheduling, and staff assignment and training.
• Guide, plan, and lead ISO 17025 certification and annual recertification activities.
• Coordinate metrology activities in alignment with production schedules, compliance requirements, and time‑sensitive project deadlines.
• Maintain PSC calibration and loaner equipment onsite at BioTechnique.
• Collaborate with PSC project managers and the Pomona team to support calibration and equipment needs during client project initiation and execution.
• Provide calibration services for equipment including temperature and humidity probes, balances, data loggers, BSCs, heat presses, gauges, thermocouples, and other instruments as required.
• Schedule, perform, and verify calibration of instrumentation under the Metrology program.
• Develop and execute calibration, testing, repair, and evaluation plans and procedures to maintain measurement accuracy and precision.
• Set up standard and specialized laboratory equipment to test, evaluate, and calibrate instruments and test equipment.
• Perform routine calibration, repair coordination, and equipment scheduling internally or through third‑party providers, including sourcing rental replacements when needed.
• Align, repair, replace, and balance component parts and circuitry as required.
• Maintain detailed records of calibration activities, including procedures, results, deviations, corrective actions, and supporting documentation.
• Coordinate and/or conduct internal audits to assess compliance with FDA and EU metrology standards and report gaps to senior management.
• Manage and audit third‑party calibration laboratories supporting BioTechnique equipment.
• Review and approve document change notifications for SOPs, test methods, specifications, protocols, and related control documents.
• Perform initial and final review and approval of Change Control requests and CAPAs related to metrology equipment, facilities, utilities, and methods.
• Ensure all calibration activities comply with NIST, cGMP, CFR, FDA, EU, and applicable federal and local regulations, including 21 CFR 210, 211, and 820.72, utilizing GAMP and GAMP 5 lifecycle practices.
• Develop and maintain a metrology inspection roadmap, incorporating current standards and next‑generation metrology technologies.
• Lead key performance metrics related to calibration services, productivity, and quality improvements.
• Stay current with industry trends and advancements in metrology and calibration technologies.
• Support validation and facilities teams in bringing new facility, manufacturing, and laboratory equipment online.
• Collaborate with manufacturing, engineering, validation, facilities, and quality teams to maintain site compliance.
• Train and support on‑site and off‑site calibration technicians to ensure consistent and accurate calibration practices.
• Participate in training programs to maintain proficiency and support professional development.
• Comply with all company policies, procedures, and safety regulations.
• Perform additional duties and responsibilities as required.

Benefits

• Medical, Dental, and Vision - BioTechnique pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
• Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
• 401(k) and 401(k) matching
• PTO, Sick Time, and Paid Holidays
• Education Assistance
• Pet Insurance
• Discounted rate at Anytime Fitness
• Financial Perks and Discount

What This Job Offers

• Job Type: Full-time
• Career Level: Manager