Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (
GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
The Manufacturing Sciences & Technology (MSAT) Documentation Scientist is responsible for strengthening operational excellence by developing and maintaining GMP documentation, coordinating training programs, and driving continuous improvement initiatives. This role partners with cross-functional teams to implement documentation and training strategies, ensure regulatory compliance, support audits and inspections, and enhance workforce readiness through effective knowledge management and process improvement in a regulated pharmaceutical manufacturing environment.
How will you make an impact?
- Technically supports day-to-day Operations and Manufacturing Sciences and Technology in the Manufacturing, Filling, Freeze Drying, and/or Packaging areas of the Steriles business unit.
- 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, Batch Records, Protocols, training documents, etc. Author Change Controls, 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. Associate degree is preferred. Other Education and time in industry can be considered.
- 0-2 years of progressive scientific experience and/or coursework
- 2-4 years of scientific experience (preferred), preferably in the pharmaceutical industry. Education and time in the industry can be considered.
- Experience with technical writing is a plus
- Equivalency: 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.