Job Description

This Engineer position will provide engineering support of the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, primarily for non-sterile operations under the remit of Our Company's Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering group (Pharm Ops Engineering).

The FLEx facility supports the formulation and filling of clinical, stability, and developmental supplies for Oral Solid Dosage (OSD) and Inhalation products, including critical program needs related to new products undergoing process development, new products undergoing scale-up, launch and transfer to the supply network and existing commercial products undergoing process optimization.

Primary responsibility will be to assist maintaining all equipment in accordance with GMP and Safety requirements, as well as exercising Reliability Maintenance best practices to ensure timely availability of Clinical Supplies and Development Batches to meet Clinical Development Program requirements. This will require routine interaction with Partner Groups such as Facilities Management (FM/GWES) and Original Equipment Manufacturers (OEM). Collaborate and interface with the OSD Business area ensuring manufacturing activities are not delayed.

Provide engineering and quality engineering (QE) support, ensuring facilities, utilities and equipment are maintained and are suitable for both GMP and developmental use. Author, review, and update GMP procedures and documentation, with an emphasis on Qualification / Validation plans and annual reports supporting equipment, critical utilities, and computer systems. Demonstrate knowledge of equipment operation to support troubleshooting, drive operational improvements, and contribute to protocol development.

Prepare and execute qualifications, commissioning, and decommissioning activities. Maintain GMP documentation where applicable, such as GMP engineering drawings and equipment database tracking. Facilitate and/or participate in Quality Notification (QN) reporting, investigations and any related corrective action/preventive action (CAPA). Support routine internal audits and various regulatory inspections by providing timely/accurate responses to questions and/or observations.

Facilitate equipment/system changes, execute periodic reviews and support Quality Management System (QMS) activities. Provide capital project support for both smaller projects and larger multi-disciplinary projects. 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.

The FLEx Center operates on a two-shift schedule and will require coverage beyond standard business hours.

Education Minimum Requirement:

• Bachelor's Degree in Engineering or Science plus a minimum of 3 years of related Drug Product/OSD experience.

Required Experience and Skills:

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

• Familiarity performing Root Cause Analysis and investigation

• Troubleshooting ability (mechanical/electrical/automation) and capital project (support).

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

• Effective organizational skills.

• Effective communication

• Strong computer skills

Preferred Experience and Skills:

• Engineering, maintenance & calibration experience of pharmaceutical processing equipment and utility systems.

• SAP Training and skills - Project Manager (PM) role, SAP Plant Maintenance

• eVal - Paperless electronic validation system

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

• Familiarity with Planning and Scheduling practices as well as business/financial practices.

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

#PSCS

#eligibleforERP

Required Skills:

Adaptability, Adaptability, Capital Projects, cGMP Guidelines, Clinical Development, Cognitive Flexibility, Electronic Batch Records, GMP Compliance, Laboratory Experiments, Mammalian Cell Culture, Personal Initiative, Pharmaceutical Process Engineering, Pharmaceutical Processing, Pilot Plant Operations, Process Engineering, Process Optimization, Product Formulation, Protocol Development, Quality Management, Regulatory Inspections, Reliability Management, SAP Plant Maintenance (PM), SAP Support, Standard Operating Procedure (SOP) Writing, Sterile Manufacturing {+ 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

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

$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:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day, 2nd - Evening

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

12/31/2025

*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.