dt~4mo ago

Associate Process Development Scientist/Engineer 1

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Job Title: Associate Process Development Scientist/Engineer 1
Department: Process Development & Technical Operations
Reports to: Manager, Product & Process Development & Quality Control
Location: Bloomington, IN (Onsite)
Position Type: Full-time, 40 hours/week, Exempt

General Responsibilities:
1. Support the Product and Process Development department as a technical writer on parenteral drug product manufacturing projects.
2. Stays current with bodies of knowledge, identifying best practices, regulatory requirements, industry standards and trends.
3. Share knowledge gained with client employees.
4. Support planning and implementation of process improvements.
5. Execute procedures and protocols.
6. Assist in authoring Batch Records and Specification sheets for Formulation, Filling, Inspection and Finishing.
7. Collaborate in writing and responding to deviations, investigations, and corrective actions.
8. Maintains knowledge of and performs functions in compliance with laws and regulations including but not limited to Company’s policies and standard operating procedures, FDA and similar regulatory authorities.
9. Positive Attitude and willingness to work as part of a diverse team to achieve overall goals of the company.
10. Comply with quality and safety management systems including requirements for documentation, training, system use, SOPs, processes, and procedures. Ensure procedures are followed and changed if no longer applicable.
11. General support required of a company where everyone is expected to perform multiple tasks both inside and outside their department to meet the needs of the business.
12. Operational knowledge of Cytiva/Vanrx SA25 or other robotic filling isolator is a plus.

Skills and Physical Activity Requirements:
1. Able to support the client team in organizing and leading meetings and driving projects to meet operational deliverables.
2. Proficient with electronic systems, including but not limited to enterprise resource planning (ERP), and Microsoft Office applications, particularly Word, Excel, PowerPoint and Project.
3. Trustworthiness and personal integrity – able to maintain a high degree of confidentiality
4. Strong verbal, listening and written communication skills.
5. Good time management and organizational skills.
6. Positive attitude and good judgment.
7. Customer focused both to internal staff and external clients.
8. Proficient math and chemistry skills required including knowledge of manufacturing methods.

Education Requirements:
1. Bachelor’s degree in a scientific discipline
2. Minimum of 1 year pharmaceutical and/or life science experience preferred
Or
3. Associates degree in a scientific discipline and 6+ years’ experience in a pharma industry, formulation and aseptic manufacturing experience required

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