Specialist, Engineering (Onsite)

MSD•Rahway, NJ

5d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

Assist maintaining all equipment in accordance with GMP and Safety requirements
Exercising Reliability Maintenance best practices
Collaborate and interface with the OSD Business area ensuring manufacturing activities are not delayed
Provide engineering and quality engineering (QE) support
Author, review, and update GMP procedures and documentation
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
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