Work ScheduleStandard (Mon-Fri)
Environmental ConditionsAble 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 DescriptionPosition SummaryThermo 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 skills.
- Ability to manage multiple assignments and priorities within established timelines.
- Ability to work effectively both independently and within cross-functional teams.
- Strong written and verbal communication skills.
- Proficiency with Microsoft Office applications, including Excel, Word, Outlook, and PowerPoint.
- Ability to work onsite in a manufacturing environment and comply with applicable PPE, gowning, and cleanroom requirements.
Knowledge and Skills- Understanding of manufacturing and process engineering principles.
- Familiarity with Lean manufacturing and continuous improvement methodologies.
- Familiarity with structured problem-solving and risk-management tools such as root cause analysis, FMEA, and risk analysis.
- Understanding of equipment and manufacturing process lifecycle principles, from design and implementation through sustainment and obsolescence.
- Ability to interpret engineering drawings, specifications, process documentation, and manufacturing requirements.
- Strong technical writing and documentation practices.
- Strong analytical and troubleshooting capabilities.
- Effective written and verbal communication skills.
- Strong attention to detail and commitment to quality, safety, and continuous improvement.
Preferred Qualifications- Manufacturing engineering experience within medical device, diagnostics, biotechnology, pharmaceutical, or another regulated manufacturing environment.
- Working knowledge of cGMP, FDA requirements, ISO 13485, and regulated quality systems.
- Experience supporting diagnostic reagent formulation, filling, labeling, packaging, or comparable manufacturing processes.
- Experience with process validation and equipment qualification, including IQ/OQ/PQ and/or CQV activities.
- Experience applying statistical analysis or statistical process control methods to manufacturing performance and process improvement.
- Experience with CAD software, equipment/tooling design, manufacturing automation, controls, and/or manufacturing data systems.
- Experience designing or improving fixtures, tooling, or production equipment.
- Experience with engineering change control, CAPA, deviations/nonconformances, and regulated documentation.
- Knowledge of aseptic processing or controlled-environment manufacturing.
- Experience leading continuous improvement initiatives or cross-functional engineering projects.
- Lean Six Sigma Green Belt, Black Belt, or comparable continuous improvement certification is a plus.
Core Competencies- Analytical thinking and structured problem solving.
- Proactive, continuous improvement mindset.
- Effective cross-functional collaboration.
- Clear technical communication.
- Strong organization and project execution.
- Attention to detail and commitment to quality.
- Ability to prioritize competing manufacturing needs in a dynamic production environment.
- Ability to communicate technical concepts and provide appropriate training or guidance to manufacturing personnel.
Compensation and BenefitsThe salary range estimated for this position based in Virginia is $66,000.00-$99,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
- A choice of national medical and dental plans, and a national vision plan, including health incentive programs
- Employee assistance and family support programs, including commuter benefits and tuition reimbursement
- At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
- Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
- Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
