Title: Manufacturing Associate
Location: Exton, PA
Schedule: Full Time M-F
Target Start Date: ASAP
Performance of all critical manufacturing steps in support of all GMP operations in the Support Operations group. The Manufacturing Associate will execute the preparation of media/buffer solutions utilizing disposable mixing technology, raw material sampling and submission, and preparation of process equipment using a washer and autoclave.
- Provide hands-on support in the operation of equipment to support commercial manufacturing.
- Perform review and revision of SOPs and master batch record instructions to improve operational accuracy and efficiency.
- Execute SAP transactions in a commercial environment.
- Support in troubleshooting product and equipment issues and deviations. Assist in providing timely reporting, investigation, and resolution of manufacturing deviations, change control, and corrective/preventive actions.
- Interact cross-functionally with Downstream Operations, Upstream Operations, Facilities, R&D, Quality Assurance, Quality Control, Validation, and other internal and external functions to support successful commercial manufacturing campaigns.
- Ensure adherence of operations to cGMP, ICH, EMA and JP Guidelines as well as industry safety standards and OSHA guidelines.
- Minimum of 1-3 years’ experience in buffer/media support operations at a pharmaceutical or biotechnology company
- Knowledgeable in weigh, dispense, and sampling procedures for controlled raw materials
- Knowledgeable in the operation of all area specific production equipment such as washers, autoclaves, and disposable mixing technology for media and buffer solutions.
- Knowledge of SAP Process systems as used in a regulated manufacturing environment (not IT SAP role)
- Ability to identify, investigate, and resolve basic process and equipment problems.
- Knowledge of international (21CFR, EMEA, and JP) cGMP regulations.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.