Commissioning and Qualification Engineer, Oral Solid Dosage

Merck•Rahway, NJ

1d•Hybrid

About The Position

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.

Requirements

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

Nice To Haves

Preferred experience in Kneat (paperless validation), computerized maintenance and calibration management systems (CMMS and CCMS)
Capability to work independently while leading or facilitating tasks.

Responsibilities

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.