Serialization Engineer II
Thermo Fisher Scientific

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed

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.

Location/Division Specific Information

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 adopt 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.

A day in the Life:

• Support serialization projects as the serialization domain authority.
• Offer mentorship on serialization onboarding, client master data, and connectivity activities with current and future partners.
• Develop Optel recipes for production inclusive of recipe entry on the serialization packaging equipment based on provided master data, label layouts and client requirements.
• Develop serialization labels via Codesoft label development software.
• Attend regular meetings with the site and global serialization teams.
• Participate in engineering and validation testing for serialization connectivity activities.
• Complete and handle updates to serialization system SOP's
• Apply Good Manufacturing Practices (GMP) in all areas of responsibility.

Keys to Success:

Education

• Bachelor's degree in computer science, engineering, or related subject area.
• Equivalent combinations of education, training, and meaningful work experience may be considered.

Experience

• 2+ years of engineering experience; computer or electrical engineering preferred.
• Computer savvy
• Requires understanding and proficient use of SOPs required by company Quality standards.
• Requires excellent organizational, planning, verbal, written and numerical skills with the ability to analyze and define solutions and balance multiple tasks to meet timelines.
• Requires strong and effective communication with the ability to effectively present information and respond to serialization questions from groups of managers and clients.
• Requires ability to develop strong customer management skills; proactively anticipates, understands, and responds to the needs of clients to meet or exceed their expectations.
• Requires ability to learn and master all internal systems associated with projects (i.e. Tracelink, Codesoft, Trackwise, eDMS).

Knowledge, Skills, Abilities

• Experience with DSCSA (Drug Supply Chain Security Act), HDA (Healthcare Distribution Alliance) compliance (GS1 and FDA guideline support) and other serialized market regulations.
• Experience with Tracelink or equivalent EPCIS providers.
• Experience with serialization equipment / system setup and equipment validation.
• Experience with label design in Codesoft or equivalent software program.

Physical Requirements

• Stand continuously (95%-100%)
• - Walk frequently (50% - 79%)
• Sit (up to 49%)
• Lift and/or carry up to 50 pounds frequently (50%-79%)
• Bend frequently (50%-79%)
• Squat (up to 49%)
• Reach above shoulder level frequently (80%-94%)
• Use both right and left hand for repetitive action, simple grasping, pushing and pulling and fine manipulation frequently (80%-94%)
• Use both right and left foot for repetitive action occasionally (up to 49%)
• You must have clear close and distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus for this role.

BENEFITS:

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

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