Computer System Validation Csv Pharmaceutical Jobs in Edison, NJ

Job Description 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.

• 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 21CFR11 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.

Minimum Requirements (standard for each level) Bachelor’s degree, or higher, in analytical chemistry or related field with 3+ years relevant industry experience.

• 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.

• 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.

• 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

We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.

As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement. We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment.

The salary range for this role is $96,200.00 - $151,400.00. 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 https://jobs.merck.com/us/en/compensation-and-benefits.

Job Posting End Date: 09/5/2026. A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship: No

Travel Requirements: 10%

Flexible Work Arrangements: Not Applicable

Shift: 1st - Day

Valid Driving License: No

Hazardous Material(s): n/a

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance