We are seeking an experienced Manufacturing Engineer – Controls with a focus on automation equipment development, implementation, and validation to join our Mobius Engineering Automation Team in Danvers, MA. Mobius Engineering is focused on the production of single-use biopharmaceuticals assemblies.

This will include supplier development, calibration, internal auditing, NCMR, CAPA, quality engineering, production support efforts including validation/testing. Represent Quality/Regulatory for new and existing product improvements; support regulatory change assessments, validation protocols, procedures and specification development.

Write or review and approve equipment IQ/OQ and assay Verification/Validation studies in collaboration with cross-functional teams. ASQ certified Quality Auditor and/or Quality Engineer - CQE, CRE, PE, CRA and/or Lean Six Sigma Certifications are highly desirable.

Working knowledge of APQP control plans and PPAP validation plans is strongly desired. These product offerings include adhesives, sealants, coatings, lubricants, additives, and cleaners for Transportation, Electronics, automotive aftermarket, MRO, Industrial Cleaning and Lubrication, New Energy, and Marine industry customers with unique needs.

Operate Ion Implant equipment and Simulator system to perform hardware and software validation, and utilizing various test methodologies, tools, and applications. Knowledge reading electrical schematic, and mechanical assembly drawing to perform installation and validation.

Coordinates the process validation of both thermoplastic and silicone injection molds working with Process Engineering/Quality – responsible for final validation of product. Interfaces with customers and suppliers on project matters, mold and fixture design, validation, and product quality issues.

In close collaboration with Hardware Engineering, Supply Chain, Manufacturing, Operations, Finance and Reliability and Maintenance (RME) partners, this role will own retrofit projects from ideation through execution and validation.

Coordinate commissioning and validation activities on-site with commissioning agents and site automation engineers. Schedule commissioning and validation activities with the Validation Engineering Team.

Initiates, plans and provides staff education, and performs competency and skills validation for care team staff, such as LPN's, HHA's and RN visit staff. Completes documentation timely, accurately, and at the point of care, according to industry standards, conventions and guidelines, including OASIS assessments, SOC/Admissions, Recertifications, ABNs, subsequent visits, physician orders, care coordination etc.

Ensures timeliness of MA DPH Validation visits and adherence to mandated standards. Stays updated on national trends in stroke care and ensures that Salem Hospital remains in compliance with MA DPH and AHA criteria.

Partner with budget managers on financial administration for monthly invoice validation, budget oversight, and verification of services rendered. Building on the quality, nonprofit heritage of our founding organizations, Tufts Health Plan and Harvard Pilgrim Health Care, we leverage our experience and expertise to help people find their version of healthier living through a broad range of health plans and tools that make navigating health and wellbeing easier.

Compile study, validation, and qualification records and paperwork, as well as facility and equipment records. Will support analytical chemistry team where hires will provide quality control review of raw analytical data/instrument output (LC/MS/MS and GC/MS) such as calibrations, sample data, laboratory records, and final data before delivery to clients.

You will work on a talented team of diverse engineers to design and develop propulsion systems through the complete product life cycle from initial requirements through validation. About FGC PlasmaFGC Plasma Solutions is a nine-year-old startup company founded in 2013 to commercialize research performed at Case Western Reserve University on plasma-assisted combustion.

May assist engineering or manufacturing technicians with validation of processes, product and tooling. Understanding of manufacturing work environment, quality standards and use of hand toolsKnowledge of material handling and proper use including labelingPrefer knowledge of microscope functionalityThe Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion.

Lead analysis of defective components in Incoming Inspection and work with vendors to resolveManage supplier process validation activities by applying a risk based approachImplement continuous improvement within supply chain Required.