Job Description

This Engineer position will be responsible for providing essential technical support for processing equipment in the FLEx Oral Solid Dosage (OSD) area for clinical drug product manufacturing, located in Rahway NJ. The FLEx OSD area supports the formulation and manufacturing of oral products for intended for critical clinical trials.

The area is inclusive of the following processes: milling, blending, tableting, film coating, roller compaction, and hot melt extrusion. Equipment uniqueness and complexity varies and often includes isolators, dedicated dust collectors, and wash-in-place systems to limit operator exposure.

A significant increase in the number of pipeline programs necessitates a need for a potential 2nd shift to support clinical supply and product development. This position is primarily intended for 1st shift, but batch activity may necessitate some off-shift support

The ideal candidate will possess strong knowledge of mechanical systems, P&IDs (Piping and Instrumentation Diagrams), electrical drawings, and troubleshooting & maintenance techniques. In addition to technical expertise, this individual will demonstrate excellent communication skills and the ability to train and upskill team members to ensure operational excellence in a highly regulated, drug product manufacturing environment.

Key Responsibilities:

• Leading personnel with skilled technical capabilities expertise in the field of Electro/Mech technologies within Pharma processing equipment cGMP procedures.

• Understanding and diagnosing issues of processing equipment along with troubleshooting complex equipment utilizing PID, Electrical schematics, Diagrams, Equipment manuals/Mechanical drawings etc.

• Ability to operate testing equipment such Multimeter, calipers, tachometer, anemometer and NIST calibration.

• Knowledge and understanding of UL ratings, SISTEMA, NRTL testing and (Energy control procedures) such as LOTO.

• Knowledge and diagnosing of Robotics, Vision systems, PLC's, machine control systems, dual channel safety circuits, ladder logic.

• General computer skills including MS office, User Specifications for equipment. General maintenance of processing equipment.

• Oversee routine and preventive maintenance on equipment and machinery within the sterile manufacturing area to ensure reliable and safe operation.

• Support equipment qualification and validation processes in compliance with cGMP (current Good Manufacturing Practices) and regulatory standards.

• Collaborate with cross-functional teams, including engineering, quality, and operations, to ensure optimal equipment performance.

• Support the implementation of continuous improvement initiatives to enhance equipment reliability and manufacturing efficiency.

• Communicate effectively with team members and leadership to report maintenance issues and offer solutions.

Qualifications:

* Associates with a minimum of 5 years of experience engineering or technical degree, or relevant experience supporting drug product process equipment.

* Minimum of 3 years of experience in mechanical maintenance, preferably in a pharmaceutical manufacturing environment.

* Strong understanding of P&IDs, electrical schematics, and the ability to interpret technical documents for troubleshooting.

* Proficiency in mechanical, electrical, and pneumatic systems, with a strong focus on troubleshooting and repair.

* Experience working in cGMP-compliant environments is a plus.

* Excellent communication skills, both written and verbal, with the ability to convey technical information clearly.

* Ability to train and mentor others, fostering a culture of continuous improvement and skills development.

* Ability to work independently and collaboratively in a fast-paced, regulated manufacturing environment.

* Strong organizational skills and attention to detail.

* Availability for shift work or on-call support as needed.

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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 Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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:

Relocation:

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Travel Requirements:

Flexible Work Arrangements:

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Requisition ID:R332261