Specialist, Analytical AR&D (Onsite)

Job Description

Title: Specialist, Metrology and Validation, Analytical Research & Development

Job Description -

The Analytical Research & Development (AR&D) External Capabilities, Validation, and Compliance (ECVC) department of our company's Research Laboratories 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 AR&D network. The role oversees and supports the onboarding, qualification, validation, and routine maintenance of analytical equipment and instrumentation within the GMP environment.

The key responsibilities of this role will include:

• Partner with scientific teams across AR&D 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 to ensure 21 CFR part 11 Compliance
  • Support standardization activities for System Development Life Cycle
  • 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) drafting
• Originate and own Investigations and Change Management records

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.- -

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 metrology and equipment maintenance and calibration and computerized equipment or instrument validation
  • Experience working within a GMP environment.-
  • Understanding of GMP policies and procedures.

Preferred Experience and Skills -

While not required, experience in one or more of the following areas is beneficial.-

• Demonstrated commitment to diversity and inclusion-
• Experience with IT, computerized systems, software and applications

• 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

Tag: #AR&D

#eligibleforERP

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
$94,300.00 - $148,500.00

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:
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

Required Skills:
Adaptability, Adaptability, Analytical Chemistry, Analytical Instrumentation, Change Management, Communication, Computer System Validation (CSV), Data Analysis, Diversity and Inclusion (D&I), Equipment Maintenance, Experimentation, GMP Compliance, GMP Environments, Inventory Management, Lab Equipment Maintenance, Laboratory Equipment Installation, Management Process, Metrology, Metrology Equipment, Personal Initiative, Pharmaceutical Management, Pharmacy Regulation, Quality Auditing, Regulatory Compliance, Reviewing Literature {+ 4 more}

-Preferred Skills:

Job Posting End Date:
08/8/2025
*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: R358807