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Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) 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

Join Thermo Fisher Scientific to contribute to meaningful projects like curing cancer and ensuring food safety.

Fisher Clinical Services excels in global clinical supply chain with outstanding dedication to quality and expertise.

Location/Division Specific Information

Our services span project management, packaging, distribution, transportation, and clinical supply optimization.

How will you make an impact?

Joining our distributed team means your actions play a crucial role in furthering our mission to help customers improve the health, cleanliness, and safety of the world.

What will you do?

Focus on continuous improvement by collaborating with Engineering and Operations Staff. Recommend efficiency improvements and cost-saving initiatives aligned with business objectives and lead project assignments.

How will you get here?

Engineering Responsibilities:

+ Applies Good Manufacturing Principles in all areas of responsibility

+ Demonstrates and promotes the company vision of the 4 I’s: Integrity, Intensity, Innovation, and involvement

+ Conducts all activities in a safe and efficient manner

+ Conducts Tech Transfer activities to onboard new and existing clients in accordance with project timeline deliverables

+ Capable of guiding and coordinating multiple project tasks from inception to completion with reliable project management approaches

+ Establishes a solid focus on long-term continuous improvement activities through interaction with the entire Engineering and Operations Staff. Recommend and lead methods for improving efficiency and reducing waste through PPI initiatives

+ Completes deviation investigations, change controls, and corrective/preventative actions

+ Evaluates and standardizes machine setups to improve both run speed and quality

+ Provides and maintains other supporting documentation for designs and projects

+ Requires ability to learn and master all internal systems associated with projects (i.e. Tracelink, Codesoft, Trackwise, eDMS)

+ Other duties may be assigned to meet business needs

Serialization-Specific Responsibilities

+ Assist in tech transfer onboarding and connectivity activities for new and existing partners, including client master data coordination

+ Develop Optel recipes for production, including integration of client master data and label layouts

+ Craft and approve serialization labels using Codesoft labeling software

+ Lead testing for serialization equipment and system connectivity

+ Maintain and update SOPs related to serialization to align with global and local compliance frameworks

+ Be responsible for the setup and ongoing production of serialization equipment and collaborate with Tracelink or other EPCIS providers

Preferred Qualifications

+ 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

Knowledge, Skills, Abilities

+ Proficient in process improvement and industrial design applications relevant to a job shop setting. Previous experience with mechanical and process equipment required. Skilled in mentoring and training others.

+ Must have a baseline level of mechanical skill established by testing

+ Must have strong analytical skills

+ Must have strong technical writing skills with experience writing Change Controls, Requirement Specifications (Design, Functional, User), FMEAs, Commissioning Protocols, SOPs, and Work Instructions

+ Must be able to multitask and respond to shifting priorities

+ Must be proficient with computer software (MS Office) and have expertise with spreadsheets

+ Must have strong and effective communication with the ability to effectively present information and respond to serialization questions from groups of managers and clients

+ Experience in Lean Manufacturing, Six Sigma, and PPI

+ Proficiency in skills required to read, understand, and adhere to the SOPs and policies of a GMP environment

Education:

A four-year, Bachelor of Science degree from an accredited college and/or university in Packaging, Mechanical, Electrical Engineering or related field with 1-3 years of equivalent experience or 7-10 years in relevant GMP, pharmaceutical or food industry.

Physical Requirements

+ Capable of lifting up to 10 lbs occasionally and/or a negligible amount frequently to move objects. Involves sitting with occasional walking or standing.

Join us and contribute to our unusual mission—enabling our customers to make the world healthier, cleaner, and safer.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

We provide accommodations for individuals with disabilities during the application, interview, work tasks, and employment benefits. Contact us for assistance.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.