Specialist, Analytical Instrument Validation (On-site)

MSD Malaysia; Rahway (NJ); On-site; USD 96,000 - 151,000; Full time

Job summary

Merck & Co., Inc. in Rahway, New Jersey is seeking an Analytical Instrument Validation Specialist to drive compliance and instrument validation across multiple sites in a GMP environment.

You will partner with DSCS teams to ensure SDLC compliance, contribute to SOPs, and support audits and change management. Strong communication and problem-solving skills are essential.

Qualifications

• Bachelor's degree or higher in analytical chemistry or related field; 3+ years post-degree industry experience.
• Strong teamwork and cross-functional collaboration.
• Experience in GMP environments and instrument validation.
• Excellent verbal and written communication; problem solving.

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.

Skills

Team player

GMP experience

Instrument validation

Problem solving

Communication skills

Education

Bachelor's degree in analytical chemistry or related field

Tools

IT systems

Quality management software

Job description

Job Description The Pharmaceutical Analysis & Digital Technologies (PADT) External Capabilities, Validation, and Compliance (ECVC) department of our company Research Laboratories Division is seeking applicants for a Validation Specialist position available at either the Rahway, New Jersey research facilities. 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 environment for multiple sites (Pennsylvania, New Jersey, and Schachen, CH).

The key responsibilities of this role will include:

• 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 (standard for each level)

Bachelor’s degree, or higher, in analytical chemistry 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
• 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
• Experience in Instrument commissioning, qualification, and validation (CQV)

Preferred Skills:

• Adaptability
• Adaptability
• Analytical Chemistry
• Analytical Instrumentation
• Analytical Laboratory Equipment
• Change Management
• Code of Federal Regulations Title 21
• Computer System Validation (CSV)
• Data Analysis
• Diversity and Inclusion (D&I)
• Equipment Maintenance
• Experimentation
• GMP Compliance
• GMP Environments
• Inspection Readiness
• Inventory Management
• Metrology
• Operational Excellence
• Personal Initiative
• Pharmaceutical Compliance
• Regulatory Audits
• Regulatory Compliance
• Reviewing Literature
• Standard Operating Procedure (SOP) Writing
• Systems Development Lifecycle (SDLC)
• {+ 3 more}

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.

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.

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

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. The application deadline for this position is stated on this posting.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.