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Job Description

This Engineer position will provide commissioning, qualification, and validation support as well as engineering support under the remit of Our Company's Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering group (Pharm Ops Engineering). This position is based at the West Point, PA site but support of and routine travel to the Rahway, NJ site may be required.

Primary responsibility will be to provide ongoing commissioning/qualification/validation related to changes and new equipment purchases within our Research & Development Division's Clinical Supply. This will require routine interaction with business areas across the site such as Vaccine Process Research & Development, Global Clinical Supply, and Analytical Research & Development, facilities/engineering partner groups such as Engineering, Maintenance, and Utilities (EMU), and Original Equipment Manufacturers (OEM).

Provide commissioning, qualification, and validation support, ensuring facilities, utilities and equipment are qualified and are suitable for both GMP and developmental use. Author, execute and review/approve GMP documentation, with an emphasis on Qualification and Validation plans around equipment, critical utilities and computer systems. Prepare and approve qualification protocols and summary reports. Execute qualifications, commissioning and decommissioning activities. Prepare Validation plans and annual reports around critical equipment and systems. Maintain GMP documentation. Facilitate and/or participate in Quality Notification (QN) reporting, investigations and any related corrective action/preventive action (CAPA). Support equipment/system changes, execute periodic reviews and support Quality Management System (QMS) activities. Interface with site engineering and maintenance groups, as well as outside vendor support. Support is inclusive of both ongoing operations and installation of new capital/facility improvements.

Education Minimum Requirement:

+ Bachelor's Degree in Engineering or Science plus a minimum of 3 years of related qualification/validation experience.

**Required Experience and Skills** :

+ Knowledge of commissioning, qualification/validation processes including periodic review.

+ Familiarity with Quality, cGMP, Safety & Environmental Policies and Procedures.

+ Familiarity with Computerized Maintenance and Management Systems (CMMS).

+ Troubleshooting ability (mechanical/electrical/automation).

+ Ability to flexibly adapt to flow to the work across both Quality and Facility aspects to support the business.

+ Effective organizational skills.

+ Effective communication

+ Strong computer skills

Preferred Experience and Skills:

+ Kneat - Paperless electronic validation system

+ Experience with SAP Plant Maintenance

+ Experience with ProCal as a Computerized Calibration Maintenance System (CCMS).

+ The candidate should be able to work independently and lead or facilitate tasks successfully.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

PSCS

\#eligibleforERP

Required Skills:

Adaptability, Adaptability, Analytical Instrumentation, Automation Systems, Biopharmaceutical Industry, Bioprocessing, cGMP Compliance, Change Control Processes, Computerized Maintenance Management Systems (CMMS), Data Analysis, Detail-Oriented, Electrical Systems, Engineering Support, Environmental Policy, Environmental Research, GMP Compliance, Maintenance Management, Maintenance Supervision, Mechanical Systems, Mechanical Troubleshooting, Periodic Reviews, Pharmaceutical Process Engineering, Pharmaceutical Technologies, Process Control, Quality Management System Auditing {+ 1 more}

Preferred Skills:

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 (https://survey.sogosurvey.com/r/aCdfqL) 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 (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

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

$85,600.00 - $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 https://jobs.merck.com/us/en/compensation-and-benefits .

You can apply for this role through https://jobs.merck.com/us/en (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:

25%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

10/17/2025

*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:** R369157