Be an early applicantLess than 25 applicants

This job has closed.

Company

Original Job Post

Merck · 1 week ago

Specialist - MACS Process/Facility Engineer

Rahway, NJ

Full-time

Hybrid

Mid Level

$83K/yr - $131K/yr

3+ years exp

Wonder how qualified you are to the job?

BiotechnologyHealth Care

Actively Hiring

Comp. & Benefits

Insider Connection @Merck

Discover valuable connections within the company who might provide insights and potential referrals, giving your job application an inside edge.

Responsibilities

Serve as a process team member supporting the Modality Agnostic Chemistry Scaleup (MACS) Center.

Contribute to equipment and facility design, system commissioning/qualification, and critical activity workstreams for facility startup.

Collaborate with development engineers & chemists, compliance representatives, and other team members to ensure quality and safe delivery of clinical supplies.

Support compliance investigations/change management, author GMP documentation, and manage/lead engineers in enabling facilities.

Provide direct support to areas such as Small Scale Organics Pilot Plant (SSO) and Prep Lab Area.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

GMP ExperienceFacility DesignEquipment Start-UpProcess DevelopmentCompliance SupportRegulatory FamiliarityProcess ConversionSOP PreparationCGMP DocumentsProblem-SolvingInterpersonal CommunicationOrganizational SkillsDesire to LearnLeadershipProcess Hazard AnalysisLevel of Protection AnalysisTechnical MentorshipPotent Compound ProcessingQuality SystemsProcess Utility System ManagementAutomation SystemMaintenance Coordination

Required

Bachelor’s degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or related scientific field with minimum of 3 years relevant experience, or a Master’s degree with 1 year of relevant experience.

Experience working in a GMP clinical or manufacturing supply facility.

Experience with GMP facility design, equipment start-up and/or qualification.

Experience with small molecule drug substance and/or biologics process development.

Experience in supporting compliance investigations and change management.

Familiarity with US and EU GMP and Safety compliance regulations

Ability to convert new drug substance process needs to an executable series of steps and procedures to enable acceptable product manufacture.

Ability to prepare Standard Operating Procedures (SOP) and cGMP documents.

Effective interpersonal and communication skills, both verbal and written.

Excellent organizational skills to multi-task.

Desire and willingness to learn, contribute and lead.

Track-record of independent problem-solving.

Preferred

Experience operating/maintaining pilot scale or prep lab scale equipment.

Experience in Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA)

Experience providing technical mentorship.

Experience with Potent Compound processing and containment systems (e.g., isolators).

Experience with Quality systems

Experience interacting with or overseeing the management of process utility system associated with a large drug substance pilot plant including WFI generation/distribution, Process Chillers, Vacuum Systems, etc.

Experience working in an environment with an Automation System (DeltaV, PLC, etc.).

Experience with coordinating maintenance activities around processing activities to support reliable facility operation.