Specialist, Engineering (Onsite)

Merck & Co. • West Point, PA

89d • $85,600 - $134,800 • Onsite

About The Position

This Engineer position will provide commissioning, qualification, and validation support as well as engineering support under the remit of Our Company's Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering group (Pharm Ops Engineering). This position is based at the West Point, PA site but support of and routine travel to the Rahway, NJ site may be required. Primary responsibility will be to provide ongoing commissioning/qualification/validation related to changes and new equipment purchases within our Research & Development Division's Clinical Supply. This will require routine interaction with business areas across the site such as Vaccine Process Research & Development, Global Clinical Supply, and Analytical Research & Development, facilities/engineering partner groups such as Engineering, Maintenance, and Utilities (EMU), and Original Equipment Manufacturers (OEM). Provide commissioning, qualification, and validation support, ensuring facilities, utilities and equipment are qualified and are suitable for both GMP and developmental use. Author, execute and review/approve GMP documentation, with an emphasis on Qualification and Validation plans around equipment, critical utilities and computer systems. Prepare and approve qualification protocols and summary reports. Execute qualifications, commissioning and decommissioning activities. Prepare Validation plans and annual reports around critical equipment and systems. Maintain GMP documentation. Facilitate and/or participate in Quality Notification (QN) reporting, investigations and any related corrective action/preventive action (CAPA). Support equipment/system changes, execute periodic reviews and support Quality Management System (QMS) activities. 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.

Requirements

• Bachelor's Degree in Engineering or Science.
• Minimum of 3 years of related qualification/validation experience.
• Knowledge of commissioning, qualification/validation processes including periodic review.
• Familiarity with Quality, cGMP, Safety & Environmental Policies and Procedures.
• Familiarity with Computerized Maintenance and Management Systems (CMMS).
• Troubleshooting ability (mechanical/electrical/automation).
• Effective organizational skills.
• Effective communication skills.
• Strong computer skills.

Nice To Haves

• Experience with Kneat - Paperless electronic validation system.
• Experience with SAP Plant Maintenance.
• Experience with ProCal as a Computerized Calibration Maintenance System (CCMS).
• Ability to work independently and lead or facilitate tasks successfully.

Responsibilities

• Provide ongoing commissioning/qualification/validation related to changes and new equipment purchases.
• Interact with business areas such as Vaccine Process Research & Development, Global Clinical Supply, and Analytical Research & Development.
• Ensure facilities, utilities, and equipment are qualified for GMP and developmental use.
• Author, execute, and review/approve GMP documentation.
• Prepare and approve qualification protocols and summary reports.
• Execute qualifications, commissioning, and decommissioning activities.
• Prepare Validation plans and annual reports around critical equipment and systems.
• Maintain GMP documentation.
• Facilitate and/or participate in Quality Notification (QN) reporting and investigations.
• Support equipment/system changes and execute periodic reviews.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree