The Role
The Lead Operator is responsible for operating manufacturing equipment, ensuring process equipment is maintained, troubleshooting issues, executing protocols, drafting standard operating procedures, and supporting continuous improvement initiatives. The role requires effective communication, maintaining a safe work environment, and training staff while completing operations in compliance with cGMP requirements.
Summary Generated by Built In
Summary of Key Responsibilities:
- Operate manufacturing equipment and instruments.
- Complete assigned tasks in a timely manner.
- Conduct daily activities in an organized, efficient manner.
- Perform simple, routine, complex, and critical operations.
- Troubleshoot equipment issues, when necessary.
- Ensure process equipment is appropriately maintained for operation.
- Perform and document operations in accordance with cGMP’s.
- Execute equipment qualification protocols and validation protocols.
- Routinely draft and revise standard operating procedures and master batch records.
- Recognize and initiate process deviations.
- Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved.
- Communicate effectively, both in written and verbal formats.
- Maintain training compliance.
- Ensure a safe working environment for all staff.
Required Qualifications and Skills:
- A.A.S. in a scientific discipline, or equivalent experience preferred.
- 3-5 years’ experience in a cGMP biopharmaceutical manufacturing environment required.
- Experience training/mentoring staff is a MUST! No direct reports.
- Must be able to work within and adapt to electronic systems.
- Able to work in an intense, fast-paced work environment.
- Able to function, with guidance, in a rapidly changing environment while balancing multiple priorities simultaneously.
- Able to work independently and as part of a team.
- Must be able to read, write and converse in English.
- Must have a good working knowledge of MS Office (Outlook, Word and Excel).
The Company
What We Do
MedPharm is a world-leading contract provider of topical and transdermal product design and development services. Our delivery of robust and innovative research has commanded recognition from regulators and investors alike. We utilise our unique cost-effective performance testing models to mitigate risk and accelerate development times.