Spclst, Engineering

MSD•Upper Gwynedd Township, PA

1d•Hybrid

About The Position

Seeking candidates for a Specialist position within our company's research laboratories Biologics Pilot Plant (BPP) Equipment Engineering Team. This person will perform various activities regarding equipment maintenance and engineering supporting pilot-scale campaigns for the Good Manufacturing Practice (GMP) manufacture of bulk vaccine clinical supplies. The candidate will participate in a wide range of activities including, but not limited to: Providing maintenance staff with support for all scheduled work associated with designated equipment Scheduling equipment calibrations and preventative maintenance Conducting equipment Lock Out / Tag Out Managing qualified equipment inventories Supporting equipment validation activities Authoring, reviewing, and approving change management documentation Providing engineering guidance for equipment upsets and events Ensuring GMP status of equipment and facilities Conducting Equipment Qualification Periodic Review for designated equipment Creating equipment and facility work notifications for corrective maintenance Maintaining/managing equipment parts lists for designated equipment, ordering special parts when needed. Managing small parts/accessories for equipment Leading small capital projects Evaluating new technologies and equipment for potential use in the area Supporting environmental and safety initiatives A good understanding of the regulatory guidelines governing GMP operations is important. Candidate is expected to work in a team atmosphere in close collaboration with plant personnel, EM&U, Quality, environmental, and safety groups. Some overtime (including weekends) will be required as well as occasionally supporting off-hour manufacturing.

Requirements

Previous experience supporting equipment and/or GMP manufacturing facilities, or laboratory areas
Strong teamwork and collaboration
Extensive knowledge of cGMP, Quality Systems, and equipment safety
Highly self-motivated with the ability to work in a fast-paced and dynamic setting
Adaptability
Adaptability
Analytical Instrumentation
Asset Inventory Management
Automation Systems
Bioprocessing
Calibration Management Software
Capital Projects
cGMP Compliance
Change Control Processes
Computerized Maintenance Management Systems (CMMS)
Data Analysis
Detail-Oriented
Electrical Systems
Environmental Health And Safety
Equipment Maintenance
GMP Compliance
Maintenance Processes
Maintenance Supervision
Manufacturing
Mechanical Handling
Mechanical Systems
Process Control
Regulatory Compliance
Small Business Management

Nice To Haves

Excellent organizational, problem-solving, and project management skills
Strong technical background on pharmaceutical production equipment
Experience working on teams in a matrixed organization

Responsibilities

Providing maintenance staff with support for all scheduled work associated with designated equipment
Scheduling equipment calibrations and preventative maintenance
Conducting equipment Lock Out / Tag Out
Managing qualified equipment inventories
Supporting equipment validation activities
Authoring, reviewing, and approving change management documentation
Providing engineering guidance for equipment upsets and events
Ensuring GMP status of equipment and facilities
Conducting Equipment Qualification Periodic Review for designated equipment
Creating equipment and facility work notifications for corrective maintenance
Maintaining/managing equipment parts lists for designated equipment, ordering special parts when needed.
Managing small parts/accessories for equipment
Leading small capital projects
Evaluating new technologies and equipment for potential use in the area
Supporting environmental and safety initiatives