Engineer II, Manufacturing Engineering

About this role

Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every day by enabling our customers to make the world healthier, cleaner and safer. We provide our global teams with resources to support individual career goals while advancing science and developing solutions for some of the world’s toughest challenges.

Position Summary Thermo Fisher Scientific’s Clinical Diagnostic Reagents (CDR) group is seeking a Manufacturing Engineer II to provide engineering support for clinical diagnostic reagent manufacturing within a cGMP, FDA-regulated, and ISO 13485 environment.

This role will support the performance, reliability, optimization, and lifecycle management of high-volume, high-mix manufacturing operations, including formulation, filling, labeling, packaging, and associated manufacturing equipment and automation .

The Manufacturing Engineer II will provide day-to-day technical support to production while leading or supporting engineering initiatives that improve Overall Equipment Effectiveness (OEE), First Pass Yield (FPY), scrap, cycle time, changeover time, throughput, and equipment uptime . The engineer will troubleshoot manufacturing processes and equipment, implement tooling and equipment improvements, support automation initiatives, and use manufacturing data and structured problem-solving methods to drive sustainable improvements.

Working cross-functionally with Operations, Quality, R&D, Validation, Regulatory, and other partners, the Manufacturing Engineer II will support engineering projects throughout the manufacturing lifecycle—from scope and feasibility through implementation, qualification, sustainment, and eventual equipment or process obsolescence.

Location: Middletown, Virginia (fully onsite) Relocation: Relocation assistance is not provided.

Key Responsibilities • Provide day-to-day engineering support for manufacturing operations to improve product quality, yield, throughput, equipment reliability, and overall production performance. • Support the development, optimization, implementation, and sustainment of manufacturing processes used in diagnostic reagent production, including formulation, filling, labeling, and packaging operations . • Troubleshoot manufacturing equipment and process issues using structured problem-solving methods and implement sustainable corrective actions. • Monitor manufacturing performance and analyze production data to identify trends, constraints, sources of variation, and improvement opportunities. • Lead or support continuous improvement initiatives targeting OEE, FPY, scrap reduction, cycle time, changeover, throughput, and equipment uptime . • Develop and implement equipment, fixture, tooling, and manufacturing process improvements to enhance safety, ergonomics, quality, reliability, and productivity. • Identify and support opportunities for appropriate manufacturing automation and controls improvements . • Lead or support structured root cause investigations involving deviations, nonconformances, recurring process issues, and equipment failures. • Support CAPA development, implementation, and effectiveness activities in partnership with Quality and Operations. • Support equipment qualification, commissioning, and process validation activities, including applicable IQ/OQ/PQ and CQV activities . • Author, review, and revise controlled documentation, including SOPs, manufacturing work instructions, batch records, engineering specifications, and validation protocols/reports. • Support engineering change control and applicable Management of Change (MOC) activities. • Conduct or participate in risk assessments, including FMEA and other risk-analysis methodologies . • Partner with Operations, Quality, R&D, Validation, Regulatory, and other cross-functional stakeholders to support applicable cGMP, FDA, and ISO 13485 requirements. • Maintain accurate and complete engineering and manufacturing documentation consistent with applicable data-integrity requirements, including ALCOA+ principles . • Lead or support engineering projects from scope definition and feasibility assessment through implementation, qualification, sustainment, and lifecycle management. • Provide technical guidance and training to manufacturing personnel on new or modified processes, equipment, tooling, and work methods. • Support internal and external audits and regulatory inspections, as needed. • Manage multiple engineering priorities and projects within established production and project timelines.

Minimum Qualifications • Bachelor’s degree in Mechanical Engineering, Industrial Engineering, Chemical Engineering, Biomedical/Biochemical Engineering, Manufacturing Engineering , or a related engineering or technical discipline. • 2+ years of relevant manufacturing, industrial, process, equipment, or related engineering experience . • Experience supporting manufacturing processes and/or production equipment in a manufacturing or similarly technical environment. • Demonstrated ability to troubleshoot manufacturing processes or equipment using structured problem-solving methods. • Experience developing, reviewing, or maintaining engineering and/or manufacturing documentation. • Ability to analyze manufacturing data and use results to identify and implement process improvements. • Strong analytical, technical, and problem-solving sk

Similar jobs

• Engineer II-Manufacturing — Gtweed · Selma, TX
• Manufacturing Engineer II — Andersen · Bayport, MN
• Manufacturing Engineer II — Nordson · Clinton, South Carolina, United States
• Manufacturing Engineer II — Nordson · Norwich, Connecticut, United States
• Manufacturing Engineer II — Jbtm · US - Kingston, NY
• Manufacturing Engineer II — Donaldson · Stevens Point, WI (USA)
• Manufacturing Engineer II — Sierra Space · Louisville, CO
• Manufacturing Engineer II — Terex · US-WA Redmond