Engineering Specialist - Commissioning, Qualification, and Validation (CQV)

Job Description

The Engineering Specialist is a key role within Our Company's Research Labs Pharmaceutical Sciences - Pharmaceutical Operations Engineering group (Pharm Ops Engineering), responsible for Commissioning, Qualification, and Validation (CQV) and broader engineering support across non-sterile operations, including formulation, filling, and packaging of Oral Solid Dosage and Inhalation products.

The position leads CQV development and execution for new and modified processing equipment, systems, and critical utilities.-- Author and execute protocols aligned with cGMP and develop Validation Master Plans, Project Execution Plans, and schedules to support capital projects.

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 for both GMP and development use.- This role partners with site business areas, equipment manufacturers, vendor representatives, and local suppliers, acting as a CQV subject matter expert during Quality Risk Assessments and applying Good Engineering Practice to Computerized Calibration Management Systems (CCMS) and Computerized Maintenance Management Systems (CMMS) configuration (e.g., instrumentation parameters and maintenance activities).

Responsibilities include coaching personnel in Good Documentation Practice and timely completion of required documentation; performing risk-based methodologies to assess GMP criticality; assisting with accuracy of As-Built drawings; and supporting Root Cause Analysis, CAPA development, FMEA, and PHAs for deviations encountered during CQV.

Candidates should hold a bachelor's degree in engineering or science with at least two years of qualification/validation experience, and demonstrate strong knowledge of commissioning, qualification/validation (including periodic review), familiarity with Quality and cGMP policies and procedures, and experience with CMMS/CCMS systems. Effective organizational and communication skills, strong computer proficiency, and the ability to flexibly support both Quality and Facilities work are essential, with preferred experience in Kneat (paperless validation), computerized maintenance and calibration management systems, and the capability to work independently while leading or facilitating tasks.

The role is based in Rahway, NJ, and may include travel to West Point, PA as needed. We seek individuals who demonstrate strong ownership and accountability, proactively drive sound decisions, and demonstrate responsibility. Joining this team offers meaningful opportunities for Talent Growth and to make a sustained impact on product reliability and patient safety to continue advancing our mission.

Primary Activities

• Develop, execute, and maintain Commissioning, Qualification, and Validation (CQV) documentation
• Participate in and support continuous improvement activities within the oral solid dosage facility
• Ensure adherence to Good Manufacturing Practices and demonstrate compliance with the Quality Manual, Standard Operating Procedures- (SOP), and applicable guidelines
• Support investigations and contribute to the development and implementation of corrective and preventive actions (CAPA)
• Support external and internal audits, tours, and regulatory inspections
• Complete required training in a timely manner and maintain training records in a current state

Education Minimum Requirement: -

• Bachelor's Degree in Engineering or Science plus a minimum of 2 years of related qualification/validation experience.

Required Experience and Skills

• Experience with current Good Manufacturing Practices (GMP) and Good Documentation Practices (GDocP)
• Experience in GMP pharmaceutical manufacturing plant operations
• Knowledge of commissioning and qualification/validation processes, including periodic review
• Familiarity with Quality, cGMP, Safety, and Environmental policies and procedures
• Familiarity with CMMS and CCMS
• Ability to flexibly adapt and prioritize work across both Quality and Facility-related activities to support business needs
• Strong organizational skills with the ability to manage multiple tasks and priorities
• Effective verbal and written communication skills
• Strong computer literacy, including the use of standard business software applications

• Preferred Experience and Skills

• Experience with Kneat or similar paperless electronic validation systems
• Experience with SAP Plant Maintenance
• Demonstrated ability to work independently and to lead or facilitate tasks and small projects successfully
• Working knowledge of regulatory requirements relevant to CQV for GMP manufacturing facilities and equipment
• Experience with one or more of the following: oral solid dosage (OSD), tablet compression, encapsulation, spray drying, film coating, dry powder inhalers, drug product-device assembly lines, isolators, and/or containment technologies
• Experience working with Lean, Six Sigma, and/or continuous improvement initiatives including Failure Mode and Effects Analysis (FMEAs), Process Hazard Analysis (PHAs)
• Familiarity with OSD process equipment operations

Required Skills:
Calibration Management Software, cGMP Guidelines, Computerized Maintenance Management Systems (CMMS), Computer Literacy, Equipment Commissioning, Equipment Qualification, Equipment Validations, Good Documentation Practices, Good Manufacturing Practices (GMP), Process Engineering, Process Optimization, Standard Operating Procedure (SOP) Writing, Troubleshooting, Validation

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:

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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
$87,300.00 - $137,400.00

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 .

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:
Domestic

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
04/4/2026
*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: R388904