Specialist, Global Analytical Instrument Validation (On-site)

MSD; West Point (PA); On-site; USD 96,000 - 151,000; Full time

Job summary

Merck & Co., Inc. in West Point, Pennsylvania seeks a Specialist in Global Analytical Instrument Validation to drive GMP instrument validation across the DSCS network.

You will optimize validation strategies, collaborate with cross-functional teams, and support compliance and quality initiatives in a dynamic environment. The role emphasizes regulatory knowledge, data analysis, and documentation, with opportunities to advance digital tools and AI applications to enhance efficiency and accuracy in

Qualifications

• Bachelor's degree or higher in analytical science, information technology or related field with 3+ years post-degree industry experience.
• Experience in GMP environments and regulatory compliance is required.
• Strong problem solving, communication and cross-functional collaboration skills.

Responsibilities

• Partner with scientific teams across DSCS to drive compliance and operational excellence.
• Validate instrumentation in GMP environments to 21 CFR 11 compliance.
• Support SDLC standardization and documentation efforts.
• Assist audits and maintain laboratory inspection readiness.
• Draft and contribute to SOPs; manage investigations and change records.
• Contribute to digital innovation efforts to improve consistency and efficiency.

Skills

Analytical Instrumentation

Regulatory Compliance

GMP Environments

Computer System Validation

Data Analysis

Technical Writing

Education

Bachelor's degree or higher in analytical science/IT or related field

Tools

Power Apps

Secure Desktop

Job description

Specialist, Global Analytical Instrument Validation Specialist, Pharmaceutical Analysis & Digital Technologies

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

The Analytical Instrument Validation Specialist will work as part of the integrated Validation and Compliance team and drive a culture of quality and operational excellence across the global Development Sciences & Clinical Supply (DSCS) network. The Analytical Instrument Validation Specialist role oversees and/or supports the validation of novel computerized analytical instrumentation within the GMP laboratory environment for multiple sites (Pennsylvania, New Jersey, and Schachen, CH).

Key responsibilities

• Partner with scientific teams across DSCS to drive compliance and operational excellence.
• Validate novel and time-sensitive instrumentation in GMP environments to 21CFR11 compliance.
• Support standardization activities for System Development Life Cycle globally.
• Support internal quality and external regulatory audits and maintain laboratory state of permanent inspection readiness within the scope of SDLC.
• Contribute to Standard Operating Procedures (SOP) drafting.
• Originate and own Investigations and Change Management records.
• Contribute to digital innovation activities supporting operational excellence for improved consistency, compliance, and efficiency.

Education Minimum Requirements

• Bachelor’s degree, or higher, in analytical science, information technology or related field with 3+ years post-degree 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, including applications of/for Artificial Intelligence (AI).
• Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills.
• Related industry experience with computerized equipment or instrument validation.
• Experience working within a GMP environment.
• Understanding of GMP policies and procedures.

Preferred Experience and Skills

• Demonstrated commitment to diversity and inclusion.
• Experience with IT, computerized systems, software and applications, including Secure Desktop.
• Experience with developing tools (e.g., Power Apps) or utilizing AI. 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 computer system validation.

Required Skills

• Analytical Instrumentation
• Analytical Laboratory Equipment
• Computer System Validation (CSV)
• Data Analysis
• Equipment Maintenance
• Experimentation
• GMP Environments
• GMP Laboratory
• Inventory Management
• Regulatory Compliance
• Standard Operating Procedure (SOP) Writing
• Technical Writing

Preferred Skills

• Metrology

US and Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

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

Primary Location

USA - Pennsylvania - West Point

Compensation Range

The salary range for the primary location of this role is: $96,200.00 - $151,400.00

This range reflects the Company’s reasonable expectation of the base salary applicable to this role at the time of 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.

Benefits

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.

Additional Location(s)

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional Location(s) Compensation Information

• 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

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employment Details

• Employee Status: Regular
• Relocation: No relocation
• VISA Sponsorship: No
• Travel Requirements: 25%
• Flexible Work Arrangements: Not Applicable
• Shift: 1st - Day
• Valid Driving License: No
• Hazardous Material(s): n/a

Job Posting End Date: 10/29/2026*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.