Manufacturing Scientist II

JOB DESCRIPTION

Work Schedule

First Shift (Days)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Fluctuating Temps hot/cold, Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Rapid flashing lights, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.)

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.

How will you make an impact?

• Technically supports day-to-day Manufacturing Sciences and Technology in the Manufacturing, Filling, Freeze Drying, and/or Packaging areas of the Steriles business unit.

• Investigates, creates, and validates scientific methodologies used to control raw materials, production intermediates, and final products on a complex scope of processes, products, and projects.

• May be involved in pre-clinical, clinical, and/or post-marketing stages of drug development.

• Works on technical/scientific process/product/project activities to execute strategies and technical solutions that meet client needs and expectations.

• 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.

What will you do?

• Author and improve procedures including SOPs, B atch R ecords, P rotocols, training documents, etc. Author Change Controls, etc. in electronic Quality Management System and Document Management System.

• Leads cross functional investigation teams in CAPA closure .

• Present recommendations internally.

• Leads assignments , including managing project timelines and deliverables.

• Liaises with internal Quality, Operations, Engineering, Validation, and other functional areas to meet team objectives.

• Guides and advises documentation and training strategies during implementation of new methodologies and processes.

• Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices and Safety guidelines.

• Maintains the necessary compliance status required by company and facility standards.

How will you get here?

Qualifications

• Bachelor of Science in any Science or STEM degree preferred. Other Education and time in industry can be considered.

• 2-4 years of scientific experience (preferred), preferably in the pharmaceutical industry. Education , time in the industry , and other applicable experience can be considered.

• Experience with technical writing is a plus

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

Knowledge, Skills, Abilities

• Thorough knowledge of Good Manufacturing Practices.

• Strong proficiency in Microsoft Office Suite (including 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.

• 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.