Manufacturing Projects Coordinator
Company: United Therapeutics Corporation (UTC)
Location: US - MD - Silver Spring
Description
Provide support for manufacturing-related administrative systems, including but not limited to SAP, WISDOM, TrackWise, and contract/vendor handling.
Support SAP transaction requirements for contract manufacturing tracking
Provide subject-matter-expert support for SAP
Provide support for regulatory filing initiatives in the WISDOM software environment
Provide support for contract generation, approval, and PO generation
Operation of process equipment under strict adherence to cGMP, OSHA, and United Therapeutics policies and regulations
Maintain personal cGMP training to ensure compliance
Other related responsibilities as assigned
Interacts with quality assurance, quality control, validation, process development, facilities, regulatory, and manufacturing management at all levels
Responsible for complex interactions with vendors
REQUIREMENTS:
Bachelors degree in science/engineering and/or equivalent experience
7+ years of pharmaceutical or biotechnology experience
Must be a capable user of Word and Excel applications. Experience with on-line cGMP/regulatory documentation systems is desirable.
Some travel is required
Advanced working knowledge of biotechnology/pharmaceutical production systems
Ability to manage complex projects from start to finish
Ability to lead resolution of equipment issues as required, including but not limited to investigations and process optimization
Excellent communication, analytical and organizational skills
Experience with regulatory requirements, audit responses
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer m/f/d/v EO 13201
