Specialist, Metrology and Validation (On-site

Metrology And Validation Specialist

The Pharmaceutical Analysis & Digital Technologies (PADT) Analytical Capabilities & Operations (ACO) department of our Research and Development Division is seeking applicants for a Metrology and Validation Specialist position available at the Rahway, New Jersey research facility.

The Metrology and Validation Specialist will work as part of the integrated US Metrology and Validation team and drive a culture of quality and operational excellence across the global Development Sciences & Clinical Supply (DSCS) network. The role oversees and supports the onboarding, qualification, validation, and routine maintenance of analytical equipment and instrumentation within a GMP environment.

The key responsibilities of this role will include:

• Partner with scientific teams across DSCS to drive compliance and operational excellence.
• Onboard, qualify, and maintain laboratory equipment and instrumentation in both GMP and non-GMP environment.
• Participate in laboratory computer system validation activities associated with new or upgraded instrumentation or software packages in compliance with 21
  
  CFR
  11 compliance requirements.
• Prepare, review, and approve documentation such as master inventory lists, qualification documentation, calibration documentation, computer system inventories.
• Support internal and external quality audits and maintain laboratory state of permanent inspection readiness.
• Author or contribute to Standard Operating Procedures (SOP).
• Originate and own Investigations and Change Management records.
• Collaborate with cross-functional teams to deliver department level priorities and initiatives.

The successful candidate must function both independently and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. Strong communications skills and eagerness to adapt and learn are essential attributes. As a member of our team, you will be joining scientific and technical problem solvers who are dedicated to creating the life-changing medicines of tomorrow.

Education Minimum Requirements (standard for each level)

• Bachelor's degree, or higher, in analytical chemistry or related field with 3+ years relevant industry experience.

Required Experience and Skills

• A strong team player with the ability to work both independently and cross-functionally to deliver on complex objectives.
• Proven track record of strong technical and innovative problem solving.
• Desire and ability to learn new concepts outside of core expertise and training.
• Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills.
• Related industry experience with metrology and equipment maintenance and calibration.
• Experience working within a GMP environment.
• Understanding of GMP policies and procedures.

Preferred Experience and Skills

• Demonstrated commitment to multiculturalism and inclusion.
• Experience leading a team for a common goal.
• Experience in Auditing and Compliance within pharmaceutical industry, including change management and deviation management.
• Experience supporting internal and external quality audits.
• Experience in Instrument commissioning, qualification, and validation (CQV).
• Experience in instrument computer system validation.
• Experience with IT, computerized systems, software and applications, including Secure Desktop.
• Experience with developing tools (e.g., Power Apps) or utilizing AI.

Required Skills:

Analytical Instrumentation, Analytical Laboratory Equipment, Calibration Procedures, Change Controls, Computer System Validation (CSV), Data Analysis, Equipment Calibrations, Equipment Maintenance, Equipment Qualification, GMP Environments, Laboratory Instrumentation, Metrology, Regulatory Compliance, Technical Writing, Validation Activities

Preferred

Skills:

The salary range for this role is $96,200.00 - $

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at