Commissioning and Qualification Engineer, Oral Solid Dosage

Job Description

The Engineering Specialist in our company's Research Labs (Pharm Ops Engineering) leads Commissioning, Qualification, and Validation (CQV) activities and provides engineering support for process equipment and utilities used to manufacture oral solid dosage (OSD) forms.

Supporting the FLEx (Formulation, Laboratory & Experimentation) Center in Rahway, NJ, the candidate authors and executes CQV protocols (IQ/OQ/PQ) and ensures cGMP compliance and adherence to our company's Quality Manual for new and modified equipment, systems, and critical utilities supporting capital projects and ongoing operations.

Candidates should demonstrate effective organizational and communication skills, strong computer proficiency, and the ability to flexibly support both Quality and Facilities/Equipment work are essential, with preferred experience in Kneat (paperless validation), computerized maintenance and calibration management systems (CMMS and CCMS), and the capability to work independently while leading or facilitating tasks.

The FLEx Center operates on a two-shift schedule and may require coverage beyond standard business hours. Candidates may be required to work extended 1st shift hours and provide on-call support as needed, based on demands.

Education Minimum Requirement: -

• Bachelor's degree in engineering or science and 2+ years of commissioning/qualification experience supporting OSD forms.

Required Experience and Skills

• Commissioning and qualification experience, including change controls and periodic reviews.
• Familiarity with OSD process equipment and operations (granulation, milling, blending, drying, tablet compression and coating, encapsulation).
• Experience with GMP, Good Documentation Practices (GDocP), and pharmaceutical manufacturing operations.
• Familiarity with CMMS/CCMS and validation tools (e.g., Kneat).
• Strong organizational, time-management, and communication skills (oral and written); ability to prioritize multiple tasks.
• Able to work independently and collaboratively demonstrates initiative to support team needs.
• Proficient with standard business software.

Primary Activities

• Develop, execute, and maintain CQV documentation and testing (IQ/OQ/PQ).
• Participate in and support continuous improvement activities within the oral solid dosage facility
• Ensure compliance with cGMP, the Quality Manual, SOPs, and applicable guidelines.
• Support continuous improvement initiatives within the OSD facility.
• Support investigations and implement corrective and preventive actions (CAPA)
• Support audits, regulatory inspections, and facility tours.

Required Skills:
Adaptability, Blending Vessels, Calibration Management Software, cGMP Guidelines, Computerized Maintenance Management Systems (CMMS), Equipment Commissioning, Equipment Qualification, GMP Compliance, Good Documentation Practices, Milling, Oral Solid Dosage, Personal Initiative, Process Engineering, Process Optimization, Teamwork, Technical Writing, Time Management, Troubleshooting, Wet Granulation, Working Independently

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:
04/28/2026
*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: R394656