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, Batch Records, Protocols, 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.