Specialist, Analytical Instrument Validation

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

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)

Bachelors 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

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 including Secure Desktop

• Experience with developing tools (e.g. Power Apps) or utilizing 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)

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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 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

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 employees 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 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

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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.

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