Manufacturing Engineer
Modis Engineering is currently recruiting for a Direct Hire Manufacturing Engineer job in Braintree, MA. To be considered for this position you must have at of 1-3 years of manufacturing engineering experience, in a Pharmaceutical environment.
Responsibilities:
- Creating, maintaining, and improving controlled technical documents such as prints, procedures, bill of materials, routers and life cycle documentation including Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), Commissioning documents, Validation documents (IQ, OQ, PQ, and PV), Functional Requirements and User Requirement Specifications (FRS/URS), technology transfer documents, Operation Project Plans (OPPs), and Validation Master Plans (VMPs)
- Supporting a wide variety of processing applications such as CIP/SIP, Depyrogenation, semi-automated vial washing, Formulation, Filling, sterilization (steam, gamma irradiation), labelling, packaging (tyvek tray sealing, foil pouch sealing, and deionization / sealing), centrifugation, lyophilization, automated parts washing, blending, auto-sieving, and milling in both drug and device manufacturing environments
- Supporting cGMP utilities such as boilers, process chillers, multi-effect stills, RO/DI pre-treatment, USP Purified Water, pH neutralization, clean steam, filtered compressed air, and WFI systems, located in ISO7/8 clean rooms supporting drug / device manufacturing
- Conducting feasibility study to estimate product cost and analyze capital equipment, capacity, and capability requirements
- Evaluating multiple options to select the most appropriate processes and machining methods, including design, performing engineering calculations, and technical reporting
- Skilled and knowledgeable in manufacturing and new product processing
- Competence with drafting standards and geometric dimensioning and tolerancing
- Ability to balance marketing, manufacturing, and design requirements to meet customer requirements
- Ability to lead and prioritize multiple medium complexity project assignments and complete work in a timely manner
- Ability to effectively work within a cross-functional team to complete critical project tasks
- Proficient with Statistical Process Control concepts, process development, CNC programming terminology, and tooling design concepts
Requirements:
- B.S. in engineering with a minimum of -1-3 years of manufacturing engineering experience, preference on Pharmaceutical industry
- Must have a degree in Chemical/Manufacturing/Mechanical Engineering