Lead Operator

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).