Spclst, Quality Systems

Job Description

Title: Specialist, Analytical Metrology & Validation, Global Quality Large Molecule Analytical Science

Job Description 

The Global Quality Large Molecule Analytical Science (GQLMAS) department of our Manufacturing Division is seeking applicants for a specialist to support metrology and validation team at the West Point and North Wales, PA facility. 

The Analytical Metrology & Validation specialist will work as part of the Global Quality Large Molecule Analytical Science and drive a culture of quality and operational excellence across the GQLMAS West Point and North Wales labs. This role required working with a team of metrology and equipment coordination supporting the maintenance and qualification of analytical equipment and instrumentation within the GMP and non-GMP environment.

The key responsibilities of this role will include:

·       Manage equipment assets at multiple locations

·       Gain a working knowledge of laboratory equipment to facilitate with troubleshooting and/or communicate with the vendor/ service engineer to identify resolutions

·       Participate in computer system validation activities associated with new or upgraded equipment or software packages.

·       Originate and progress Deviations and Change Control records

·       Perform and document investigations and assist in developing and implementing CAPA plans

·       Contribute to new SOP drafting, implementation, and revisions.

·       Represent the laboratory on all aspects of laboratory equipment during audits.

·       Ensure compliance with all regulatory requirements (cGMP), internal policies and procedures.

·       Customer focused mindset with the ability to communicate adequately (verbally/writing) to all levels within the organization.

·       Willingness and ability to quickly upskill in our Facilities/Instrument support programs SAP, ProCal, BAS, LAMP, Electronic Validation, and other document and/or asset repositories

·       Initiate, process and track work orders to facilitate timely repairs, modifications and moves of laboratory equipment.

Calibration Focus:

·       Prepare, review, and approve archive instrument/equipment documentation such as master equipment lists, user access reviews, Instrument Installation & operational qualification documentation, and calibration documentation.

·       Coordinate service activities across a variety of vendors and service engineers while building and maintaining strong working relationships.

·       Collaborate with metrology staff across multiple testing labs and sites for process improvement, cross-training and cross-site support.

·       Support the purchase, installation, and equipment qualification of new laboratory equipment.

Validation Focus:

·       Support primarily the qualification/validation of computerized analytical systems as per current guidelines.

·       Partner with the business unit in the laboratories, various quality support oversight, IT technical support, and various software and instrument vendors/manufacturers.

·       Perform any required change control during the life cycle of a computerized system.

·       Decommission systems as required as part of the equipment qualification/validation life cycle.

·       Manage the capital purchasing and initial installation of computerized analytical systems prior to validation.

·       Participate in various data integrity and lab modernization activities as required.

·       Will possess direct experience operating analytical instrumentation within a pharmaceutical or equivalent laboratory (vaccine or large molecule focus).

·       Will have the ability to thoroughly review and scrutinize validation requirements through the life cycle of the system.

Education Minimum Requirements (standard for each level) 

o   Bachelor's degree in biological or chemical science and/or engineering plus

4+ years of experience participating in the validation of computerized laboratory systems or instruments (e.g. system Installation and Operational qualification) or MS with 1 year of experience

Required Experience and Skills 

o   Perform and direct team validation activities as an independent author

o   Highly skilled in operating analytical computerized instrumentation within a pharmaceutical or equivalent laboratory.

o   Collaborate independently with various project teams and execute tasks efficiently

Required Skills:

Aseptic Manufacturing, Aseptic Manufacturing, Auditing, Batch Record Review, Calibration Management Software, Calibration Procedures, Consulting, Consumer Relations, Corrective Action Management, Data Analysis, Data Integrity, Decommissioning, FDA Compliance, Financial Advising, Financial Forecasting, GMP Compliance, Good Manufacturing Practices (GMP), GxP Validation, Laboratory Testing, Manufacturing Compliance, Metrology Equipment, Personal Initiative, Policy Development, Quality Control (QC), Quality Improvement Programs {+ 2 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The salary range for this role is

$85, $134,800.00

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

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

10/28/2025

*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.

Requisition ID:R371070

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