Engineer II, Manufacturing Engineering at Thermo Fisher… · Middletown

Engineer II, Manufacturing Engineering Location: Middletown, Virginia, USA 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 single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. DESCRIPTION: Thermo Fisher Scientific’s Clinical Diagnostic Reagents (CDR) group is seeking a Manufacturing / Industrial / Process Engineer to support manufacturing and process development activities for clinical diagnostic reagents. This role will contribute to the design, optimization, validation, and lifecycle support of reagent manufacturing processes within a cGMP, FDA, and ISO 13485 regulated environment. This position will help drive end-to-end performance of multiple high-volume and high-mix manufacturing lines with a variety of equipment with various levels of automation.  They will help lead cross-functional execution of engineering projects and deliver measurable gains in OEE, FPY, scrap, cycle time, changeover, and equipment uptime. They will also help drive engineering improvement initiatives, including tooling and equipment design and automation, and must be able to manage multiple projects simultaneously from scope and feasibility assessment through sustainment and end of life obsolescence. Location: Middletown, VA. Relocation assistance is NOT provided. KEY RESPONSIBILITIES: Support daily manufacturing operations to ensure consistent product quality, yield, and throughput Assist in developing, validating, and optimizing manufacturing processes for diagnostic reagent production including formulation, filling, labeling and packaging processes Author, review, and revise controlled documents including SOPs, batch records, work instructions, and validation protocols/reports Participate in process validation activities (IQ/OQ/PQ) and equipment CQV activities Investigate deviations, nonconformances, and CAPAs; lead root cause analysis investigations and implementation of corrective actions Monitor process performance using statistical tools and identify opportunities for improvement Collaborate with Quality, R&D, Regulatory, and Operations teams to ensure compliance with cGMP, FDA, and ISO 13485 requirements Assist with change control activities (MOC), risk assessments, and failure mode analyses Maintain accurate documentation in compliance with data integrity standards (ALCOA+) Support internal and external audits and regulatory inspections as needed Develop equipment tooling design improvements and/or advance levels of equipment automation REQUIREMENTS/QUALIFICATIONS: Bachelor's Degree in Mechanical Engineering, Industrial Engineering, Biomedical/Biochemical Engineering, Chemical Engineering, or related technical discipline 2-3 years of experience with manufacturing, industrial, or process engineering (within a regulated industry such as Medical Device or Pharmaceutical preferred) Strong mechanical design aptitude and familiarity with equipment and process design lifecycle components from conception through end of line obsolescence Relevant technical certifications or apprenticeships are valued Strong knowledge of cGMP, ISO standards, and regulatory standards Experience with lean manufacturing principles and continuous improvement methodologies Proficient in statistical analysis, root cause investigation, and problem-solving techniques Expertise with CAD software, manufacturing systems, and data analysis tools Experience with engineering documentation, specifications, and change control processes Experience with automation, controls, and equipment/tooling design preferred Knowledge of equipment qualification and process validation Lean Six Sigma Green/Black belt certification a plus Knowledge of aseptic processing or reagent formulation a plus Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. Core Competencies Excellent written and verbal communication skills Attention to detail and commitment to quality Proactive mindset with continuous improvement focus Strong project management abilities and experience leading cross-functional initiatives Ability to work in cleanroom environments and comply with required PPE/gowning procedures Proficiency with Microsoft Office suite software Strong analytical and troubleshooting capabilities Ability to mentor and train manufacturing personnel Must be able to occasionally lift up to 50 lbs with assistance