ThermoFisher Scientific Hiring for Engineer III for Sterile Operations and Automation at Greenville, North Carolina Full Time

Job Description

TITLE: Engineer III for Sterile Operations and Automation

LOCATION: Greenville NC

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals!

DISCOVER IMPACTFUL WORK

As a R&D/Mfg Engineer, you will provide technical support to Capital Projects Group with planning, authorization, and closing of capital projects with an emphasis on engineering and automation. In addition, the position will serve as a liaison between the Capital Project and Manufacturing / Operation personnel. Works on technical/scientific process/product/project activities to execute strategies and technical solutions that meet client needs and expectations. Participates in technical discussions with clients with a high level of technical proficiency. Engages in creation of processes and equipment design for clinical, scale up, and/or registration batches, including technology transfer of projects to and from clients. Evaluates and contributes to the design of manufacturing processes and supports problem solving as necessary with independent judgment. Makes decisions that require developing new options to solve complex problems. Focus will be on implementation of capital projects for targeted Steriles customers or Thermo Fisher future expansions. Travel required for project initiation and completion.

A DAY IN THE LIFE

• Assist in design of graded spaces for Sterile Product Division

• Assist in the User Requirement Specifications reviewing process

• Support vendor Factory Acceptance Testing and help generate punch-list items. Support Site Acceptance Testing and help confirm FAT punch-list items are addressed and generate new punch-list items (if required)

• Assist in the equipment qualification process (IOQ and PQ)

• Review Basis of Designs, Drawings and Project specs

• Initiate and responsible person for Change Controls

• Review and approve Validation protocols/summaries as qualified area person or technical resource

• Subject matter expert and resource for design and implementation of disposable technologies

• Direct customer interactions as technical subject matter expert

• Design and author Technical Protocols, Forms, Manufacturing Work Orders and Filling Work Orders for new processes.

• Oversee Mfg. and Filling during media fills

• Participate and/or Lead Sterile Product related Risk Assessments and Failure Mode and Effects Analysis

• Assist in the Equipment Risk Assessments

• Perform FMEA which must be reviewed & approved/signed by all parties after Media fills and provided to site QA

• Perform/Lead with QA Contamination Control Risk Assessments

• Own/Manage DIRs that may occur during media fills/CTM batches as designated by Ops/Tech Management

• Assist with product transfer activities as capital project technical resource

• Perform related tasks as required

KEYS TO SUCCESS.

Education:

• Bachelor’s of Science in Chemistry, Biochemistry, Biology, related physical science or Engineering. Advanced degree preferred.

Experience:

• Typically requires 5+ years of progressive scientific experience, including 3+ years in a related life sciences field. If related Master’s degree, typically requires 3+ years of related experience. If related PhD, typically requires 1+ years of experience. Experience working directly with clients.

Equivalency :

• Equivalent combinations of education, training, and relevant work experience may be considered.

Competencies:

• Advanced knowledge of varied aspects or a specialized aspect of a discipline and working knowledge of principles and concepts in other relevant disciplines.

• Excellent knowledge of scientific methodology and development as related to the pharmaceutical industry. Thorough knowledge of Good Manufacturing Practices.

• Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).

• Excellent critical and logical thinking skills. Effective written, interpersonal, and presentation skills, including managing technical discussions with internal and external clients.

• Ability to work on multiple projects simultaneously. Ability to develop knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures. Ability to keep current with scientific literature and industry trends relating to process technologies. Ability to develop technical solutions.

Physical Requirements:

• Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand and walk; ability to lift and/or carry light objects of up to 25 lbs. for brief periods.

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.