Specialist, Engineering
Merck
June 24, 2026
On-site
West Point, PA
Operations
Tasks:
- Participate in or manage Quality Notification investigations and change management activities.
- Order process consumables used in GMP manufacturing activities.
- Submit supply chain requests to Third Party Quality Management.
- Research and manage supplier notifications at direction of supplier notification lead.
- Prepare, review, and update GMP documentation (SOPs, Bills of Materials, Batch Records).
- Serve as content expert and trainer for select procedures.
- Perform data entry and electronic log creation/management.
- Support PAS-X administrative work (PVL updates, Change Controls, Manufacturing Order creation, coordinating QA approval).
- Assist with warehouse coordination (scheduling sampling, risk release management, deliveries, SAP management).
- Assist with equipment troubleshooting and calibration coordination.
- Support continuous improvement initiatives.
- Support safety, compliance, and GMP initiatives (area walkthroughs; managing/closing observations).
- Developmental role with opportunity to build toward a front-line manager position; some overtime/weekends/occasional second shift and on-call phone required.
Experience/Skills:
- Comprehension of GMP regulatory guidelines; work collaboratively with raw material release, facility operations, equipment engineering, process operations, safety, manufacturing, and quality teams.
Education:
- BS/BA in Biological Sciences, Chemistry, Engineering, or equivalent combination of education and experience.
Qualifications:
- Knowledge of current GMP regulations; independent and team work.
- Ability to manage multiple priorities; problem-solving and technical communication skills.
- Proficiency with Microsoft Office (including SharePoint and Power Platform).
Preferred:
- PAS-X, SAP/Ariba, Electronic Supplier Transparency Request, ETQ Reliance.
- Union environment experience; relevant manufacturing/processing (aseptic/sterile, bulk, solid oral dosage, packaging).
Required Skills (keywords):
- Biological Sciences, cGMP Guidelines, GMP Compliance, Personal Initiative, Pilot Plant Operations, Process Engineering/Operations/Optimization, Product Formulation, Regulatory Compliance, SOP Writing, Sterile Manufacturing, Therapeutic Proteins.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline listed on posting.
- Participate in or manage Quality Notification investigations and change management activities.
- Order process consumables used in GMP manufacturing activities.
- Submit supply chain requests to Third Party Quality Management.
- Research and manage supplier notifications at direction of supplier notification lead.
- Prepare, review, and update GMP documentation (SOPs, Bills of Materials, Batch Records).
- Serve as content expert and trainer for select procedures.
- Perform data entry and electronic log creation/management.
- Support PAS-X administrative work (PVL updates, Change Controls, Manufacturing Order creation, coordinating QA approval).
- Assist with warehouse coordination (scheduling sampling, risk release management, deliveries, SAP management).
- Assist with equipment troubleshooting and calibration coordination.
- Support continuous improvement initiatives.
- Support safety, compliance, and GMP initiatives (area walkthroughs; managing/closing observations).
- Developmental role with opportunity to build toward a front-line manager position; some overtime/weekends/occasional second shift and on-call phone required.
Experience/Skills:
- Comprehension of GMP regulatory guidelines; work collaboratively with raw material release, facility operations, equipment engineering, process operations, safety, manufacturing, and quality teams.
Education:
- BS/BA in Biological Sciences, Chemistry, Engineering, or equivalent combination of education and experience.
Qualifications:
- Knowledge of current GMP regulations; independent and team work.
- Ability to manage multiple priorities; problem-solving and technical communication skills.
- Proficiency with Microsoft Office (including SharePoint and Power Platform).
Preferred:
- PAS-X, SAP/Ariba, Electronic Supplier Transparency Request, ETQ Reliance.
- Union environment experience; relevant manufacturing/processing (aseptic/sterile, bulk, solid oral dosage, packaging).
Required Skills (keywords):
- Biological Sciences, cGMP Guidelines, GMP Compliance, Personal Initiative, Pilot Plant Operations, Process Engineering/Operations/Optimization, Product Formulation, Regulatory Compliance, SOP Writing, Sterile Manufacturing, Therapeutic Proteins.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline listed on posting.