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INCOG BioPharma Services · 1 day ago

Manufacturing Engineering Technician, 2nd shift

Fishers, Indiana

Full-time

Onsite

Senior Level

5+ years exp

INCOG BioPharma Services is a leading CDMO focused on parenteral injectable drugs. They are seeking a Manufacturing Engineering Technician to ensure data integrity, implement digital technologies, and support process engineering and operations in a highly regulated manufacturing environment.

BiopharmaBiotechnologyManufacturingPharmaceutical

Responsibilities

Resolve issues that arise in day-to-day running of operations, providing timely responses and solutions

Implement solutions in collaboration with cross-functional technical teams and site leadership team

SME for filling equipment and supporting systems

Evaluate and improve efficiency of manufacturing instruments, equipment, and tools

Evaluate and implement new changes

Participate and/or support process FMEAs to understand process and product risks as a pre-requisite for process validation

Provide technical support to manufacturing activities

Apply Good Engineering Practices (GEP) to drive site engineering and operational excellence

Partner with vendors and suppliers to define requirements and understand functional specifications

Work flexible hours to ensure production facility coverage

Qualification

CGMP manufacturingAseptic fillingProcess engineeringLean Six Sigma CertificationBiotechnology productsProblem solvingTeam collaborationLeadership skills

Required

Bachelor's degree in engineering field, or life sciences with 5+ years of relevant work experience

Or 10+ years of relevant work experience

Ability to become a SME for aseptic filling, inspection and packaging equipment

Preferred

Lean Six Sigma Certification

Practical expertise with cGMP manufacturing and regulatory requirements for pharmaceuticals and devices

Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing (fill and finish), and process development

Company

INCOG BioPharma Services

Our services include injectable drug product formulation development, analytical method development, process scale up, and formulation & filling of vials, syringes and cartridges.

Founded in 2020

Fishers, Indiana, USA

201-500 employees