✦ Luna Orbit — Engineering (Non-Software)

Process Engineer, Sterile/Liquids Pilot Plant

at Merck

📍 USA - Pennsylvania - West Point Hybrid 💰 $87K – $137K USD / year Posted April 15, 2026
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Position Details

Salary $87K – $137K USD / year
Type Not Specified
Experience entry
Exp. Years 1.5+ years
Education Bachelors of Science in Chemical Engineering, Chemistry, Biology or related Scientific Field
Category Engineering (Non-Software)

About this role

The Process Engineer supports the Sterile/Liquids Pilot Plant (SLP) at West Point, PA by providing GMP and technical expertise to ensure clinical and development batches are manufactured on time. The engineer authors batch records, supports shopfloor execution, and leads quality processes including change control and deviations with RCA and CAPA.

Key Responsibilities

  • Provide technical input on sterile processes and GMP expertise
  • Author the batch record and coordinate transfer and receipt of batch inputs
  • Provide shopfloor support during batch manufacture and manage sample & batch delivery
  • Own relevant change control and lead deviations with impact assessment, root cause analysis, and CAPA identification
  • Implement new technologies and support process improvement projects

Technical Overview

The role focuses on sterile liquid clinical and developmental batch manufacturing within a pilot plant environment, including batch planning and execution tracking against program timelines. It includes strong GMP execution, batch record authoring, shopfloor support, and quality system execution through change control, deviation leadership, impact assessment, root cause analysis, and CAPA identification.

Ideal Candidate

The ideal candidate is an early-career Process Engineer with a BS in Chemical Engineering, Chemistry, Biology, or a related scientific field and at least 1.5 years of relevant experience. They have hands-on GMP experience supporting sterile/liquids pilot plant batch manufacturing, including batch record authoring and shopfloor support. They are also strong in quality systems, owning change control and leading deviations with impact assessment, root cause analysis, and CAPA identification.

Must-Have Skills

Sterile/Liquids Pilot Plant Process Engineer (PE) responsibilities including GMP expertiseAuthoring the batch recordOwn relevant change control and lead deviationsPerform impact assessmentroot cause analysisand CAPA identificationMinimum education: Bachelors of Science in Chemical EngineeringChemistryBiology or related Scientific FieldMinimum 1.5 years experience (exact text truncated but indicates minimum 1.5 years)

Required Skills

sterile processesGMP expertisebatch planningbatch executionmanufacturing project management oversightauthoring the batch recordcoordinating transfer and receipt of batch inputsshopfloor support during batch manufacturesample & batch deliverychange controlimpact assessmentroot cause analysisCAPA identificationdeviation leadershipprocess improvement projectsimplementation of new technologiesquality and compliance requirements adherenceteam meetings facilitationagenda creationfollow-up to ensure deliverables

Hard Skills

sterile processesGMP expertisebatch planningbatch executionmanufacturing project management oversightauthoring the batch recordcoordinating transfer and receipt of batch inputsshopfloor support during batch manufacturesample and batch deliverybatch record authoringchange controlimpact assessmentroot cause analysisCAPAdeviation managementprocess improvement projectsimplementation of new technologiescreating agendas for team meetingsfollowing up to ensure deliverablesquality and compliance requirements adherence

Soft Skills

proactive obstacle identification and escalationrelationship buildingnetwork leverageteam dynamics improvementteam collaborationmeeting facilitationcommunicationcross-functional collaborationleadership with guidance from senior team members

Industry & Role

Industry Manufacturing
Job Function Deliver GMP-compliant sterile process engineering support for pilot plant batch manufacturing of clinical supplies and development batches.
Role Subtype Process Engineer

Keywords for Your Resume

Process EngineerSterile/Liquids Pilot PlantSterile/Liquids Pilot Plants (SLP)pilot plantWest PointPAsterile processesGMPGood Manufacturing Practicebatch planningbatch executionmanufacturing project management oversightbatch recordshopfloor supportsample & batch deliverychange controlimpact assessmentdeviationsroot cause analysisCAPACorrective and Preventive Actionprocess improvement projectsnew technologiesquality and complianceteam meetingsagendas

Deal Breakers

Bachelor of Science in Chemical Engineering, Chemistry, Biology or related Scientific Field, Minimum 1.5 years experience (as stated), Demonstrated GMP expertise in batch manufacturing for sterile processes, Ability to own change control and lead deviations including impact assessment, root cause analysis, and CAPA identification

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