Indianapolis, Indiana
10 days ago
Equipment Engineer

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We are seeking a skilled Equipment Engineer to join our client's operations team. This role is critical for implementing process improvements, maintaining equipment performance, and supporting continuous improvement initiatives in a highly regulated environment.

The ideal candidate will have experience in pharmaceuticals and/or biologics, GMP manufacturing, and knowledge of aseptic filling, sterile processing, and labeling.

Essential Functions

Resolve issues that arise in day to day running of operation and providing timely responses and solutionsFunction closely with operations personnel to understand their interaction with equipment and resolve issues they faceImplement solutions in collaboration with cross-functional technical teams and site leadership teamSupport filling equipment, formulation process, visual inspection equipment, and/or labeling process.Evaluate and improve efficiency of manufacturing instruments, equipment, and toolsEvaluate and implement new changesSupport operations through standard operating procedure revisionParticipate and/or support process FMEAs to understand process and product risksProvide technical support to manufacturing activitiesWork flexible hours to ensure production facility coverageMust maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA,EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

Minimum Education and Experience:

Bachelor's degree in the engineering field or bachelor's degree in life sciences with 3+ years of relevant work experienceOr High School Diploma/GED 8+ years of relevant work experience

Additional Preferences:

Lean Six Sigma CertificationPractical expertise with cGMP manufacturing and regulatory requirements for pharmaceuticals and devicesDemonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing (fill and finish), visual inspection, and labeling LSNJN1425354AJ_1767711085 To Apply for this Job Click Here

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