Safety Standards, Cleanroom:

no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description Title:

Engineer II, Manufacturing Engineering 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. Division/Site Specific Information Role reports to the Allentown, PA site and reports to the Clinical Trials Division (CTD). CTD partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time - a concept that we internally embrace as \"There is a Patient Waiting.\" Our outstanding blend of services includes project management, packaging, distribution, transportation management and specialty logistics, ancillary supply management, clinical supply optimization, bio-repository storage and much more. Our more than 3000 employees in over 15 countries work hard every day knowing that what they do matters.

Discover Impactful Work:

You will participate in new product introductions, process improvements, and equipment optimization initiatives. Using data-driven approaches and lean methodologies, you'll identify opportunities to enhance efficiency, reduce costs, and maintain the highest quality standards. Work closely with operations, quality, maintenance, R D, and other teams to implement sustainable solutions that drive manufacturing excellence. A Day in the

Life:

Support continuous improvement initiatives by working with Engineering and Operations to identify opportunities to improve safety, quality, productivity, and cost. Collaborate with Production to identify and help resolve workflow barriers that improve throughput and operational efficiency. Participate in daily production support activities to identify process issues and assist in implementing corrective actions. Support engineering projects focused on improving equipment performance, reducing waste, increasing productivity, and enhancing product quality. Participate in deviation investigations, change controls, corrective and preventive actions (CAPA), and root cause analysis under the guidance of senior engineers. Develop proficiency in reading, understanding, and following GMP documentation, SOPs, and company policies. Conduct all activities in a safe, compliant, and efficient manner. Perform other duties as assigned to support business needs. Demonstrate and promote the company vision of the 4

I's:

Integrity, Intensity, Innovation, and Involvement. Keys to

Success:

Education A four-year Bachelor of Science degree from an accredited college or university in Packaging, Mechanical, Industrial, or related Engineering discipline highly preferred. High school diploma or equivalent required. Experience 0-2 years of relevant engineering experience, or an equivalent combination of technical certification and applicable GMP, pharmaceutical, food, or manufacturing experience. Experience with engineering documentation, specifications, and change control processes. Experience with CAD software, manufacturing systems, and data analysis tools preferred. Experience with automation, controls, and process validation preferred. Experience with equipment qualification and calibration processes preferred. Knowledge, Skills, Abilities Apply Good Manufacturing Practices (GMP) in all areas of responsibility. Strong knowledge of

GMP, ISO

standards, and regulatory requirements Knowledge with lean manufacturing principles and continuous improvement methodologies Ability to work in cleanroom environments and comply with required PPE/gowning procedures Available to work flexible hours and provide on-call support as needed Proficiency with Microsoft Office suite and manufacturing software systems Strong analytical and troubleshooting capabilities Ability to mentor and train manufacturing personnel Must be able to occasionally lift up to 50 lbs with assistance Effective written and verbal communication skills and the ability to work collaboratively across functional teams. Benefits We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. 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