Specialist, Metrology and Validation (On-site)
About the role
The Metrology and Validation Specialist will work as part of the integrated US Metrology and Validation team within the Pharmaceutical Analysis & Digital Technologies (PADT) Analytical Capabilities & Operations (ACO) department at the Rahway, New Jersey research facility. This role drives a culture of quality and operational excellence across the global Development Sciences & Clinical Supply (DSCS) network, overseeing and supporting the onboarding, qualification, validation, and routine maintenance of analytical equipment and instrumentation in a GMP environment.
Responsibilities
- 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 environments.
- Participate in laboratory computer system validation activities for new or upgraded instrumentation or software packages, ensuring compliance with 21CFR11 requirements.
- Prepare, review, and approve documentation such as master inventory lists, qualification documentation, calibration documentation, and computer system inventories.
- Support internal and external quality audits and maintain laboratory state of permanent inspection readiness.
- Author or contribute to Standard Operating Procedures (SOPs).
- Originate and own Investigations and Change Management records.
- Collaborate with cross-functional teams to deliver department-level priorities and initiatives.
Requirements
- Bachelor’s degree, or higher, in analytical chemistry or a related field with 3+ years of relevant industry experience.
- 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 and understanding of GMP policies and procedures.
Preferred Qualifications
- Demonstrated commitment to multiculturalism and inclusion.
- Experience leading a team toward a common goal.
- Experience in auditing and compliance within the 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 developing tools (e.g., Power Apps) or utilizing AI.
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
Pay
The salary range for this role is $96,200.00 - $151,400.00. An employee’s position within the salary range will be based on 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.
Benefits
We offer a comprehensive package of benefits, including:
- 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 https://jobs.merck.com/us/en/compensation-and-benefits.
Schedule
- 1st shift (Day)
- 10% travel requirements
- Valid driving license not required