Sr. Specialist, Compliance/Engineering - Oral Solid Dosage (Onsite)

Job Description

Position Summary

The Senior Engineer (2nd Shift) in our Company's Research Labs (Pharm Ops Engineering) provides engineering and compliance support for the FLEx (Formulation, Laboratory & Experimentation) Center in Rahway, NJ. This role supports non‑sterile process equipment and utilities used in the manufacture of oral solid dosage (OSD) products across clinical, developmental, and commercial programs. The position operates with minimal supervision and serves as a key technical and compliance resource during second‑shift operations.   

Education

• Bachelor’s degree in engineering with a minimum of 5 years of experience supporting pharmaceutical manufacturing operations for oral solid dosage (OSD) formats

Required Experience and Skills

• Demonstrated commissioning and qualification experience supporting GMP manufacturing equipment in regulated environments

• Hands-on familiarity with OSD process equipment and operations, including granulation, milling, blending, drying, tablet compression and coating, and encapsulation

• Strong technical troubleshooting capability across mechanical, electrical, and automation systems

• Working knowledge of Quality systems, cGMP requirements, Good Documentation Practices (GDocP), and applicable Safety and Environmental policies and procedures

• Experience performing root cause analysis and supporting technical investigations in a manufacturing environment

• Familiarity with CMMS/CCMS platforms and validation documentation tools (e.g., Kneat)

• Strong organizational, time‑management, and communication skills with the ability to manage multiple priorities independently while collaborating effectively across cross‑functional teams

• Proficient with standard business and documentation software tools

Key Responsibilities

• Independently provide second‑shift engineering support for OSD process equipment and associated utilities within a GMP manufacturing environment, operating with minimal supervision

• Develop and provide shift-change notes to ensure seamless support to the 1st shift team.

• Act as the secondary technical escalation point by reviewing procedures, wiring diagrams, equipment drawings, vendor manuals, and calibration/maintenance records to diagnose and resolve issues.

• Support troubleshooting of equipment and process issues, and implement effective corrective actions in collaboration with Operations, Process Engineering, Quality, and site technical teams

• Apply engineering principles and OSD process knowledge to support routine manufacturing activities, deviation response, and investigation efforts

• Provide Quality Engineering support to ensure facilities, utilities, and equipment remain compliant, qualified, and fit for GMP clinical, developmental, and commercial operations

• Adhere to all applicable safety requirements

• Author, review, and maintain GMP documentation, including procedures, IQ/OQ protocols, qualification reports, and engineering drawings, in accordance with site and regulatory requirements

• Execute commissioning, qualification, and decommissioning activities in alignment with approved protocols, change controls, and site standards

#eligibleforERP

#PSCS

FLEx2026

Required Skills:

Adaptability, Adaptability, Analytical Testing, Data Analysis, Detail-Oriented, Deviation Management, Equipment Qualification, Equipment Troubleshooting, GMP Compliance, Good Manufacturing Practices (GMP), Manufacturing Operations, Pharmaceutical Manufacturing, Pharmaceutical Systems, Procedure Reviews, Process Architecture, Process Design, Process Engineering, Process Hazard Analysis (PHA), Process Optimization, Process Technologies, Protocol Review, Quality Engineering, Root Cause Analysis (RCA), Software Documentation, Strategic Thinking {+ 2 more}

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:

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

The salary range for this role is

$117,000.00 - $184,200.00

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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

2nd - Evening

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

05/23/2026

*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.