Communication Skills, Continuous Improvement, Current Good Manufacturing Practice (cGMP), Documentation, Documentation Standards, English Language, Equipment Maintenance/Repair, Equipment Validation, Identify Issues, Maintain Compliance, Manufacturing, Manufacturing Equipment, Manufacturing Equipment Maintenance, Microsoft Excel, Microsoft Office, Microsoft Outlook, Microsoft Word, Multitasking, Organizational Skills, Physical Demands, Process Development, Production Systems, Quality Assurance, Quality Control, Regulations, Regulatory Compliance, Research & Development (R&D), Safety Process, Safety Standards, Safety/Work Safety, Standard Operating Procedures (SOP), Team Player, Time Management, Validation Plan, Willing to Travel
Position Summary
The Manufacturing Operator is responsible for executing a wide range of operations in a cGMP-compliant biopharmaceutical manufacturing environment. This role involves operating, maintaining, and troubleshooting production equipment, performing and documenting complex and critical processes, and supporting equipment validation activities. The operator ensures compliance with standard operating procedures, safety regulations, and documentation standards while contributing to continuous improvement initiatives. Ideal candidates will have an A.A.S. in scientific discipline or equivalent experience, along with 2-4 years of hands-on manufacturing experience. The role also requires strong communication skills, proficiency with MS Office and electronic systems, and the ability to adapt in a dynamic team environment while meeting strict quality and safety standards.
Essential Functions:
- 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.
- 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.
Supervisory responsibilities:
- Direct Reports: No
- Indirect Reports: No
Key Relationships (examples: Depts or Individual positions that this position will be working closely with):
- Quality Control
- Quality Assurance
- Process Development/ Formulation R&D
- Facilities
Travel requirements:
· No
Education and Experience:
- A.A.S. in a scientific discipline, or equivalent experience preferred
- 2-4 years’ experience in a cGMP biopharmaceutical manufacturing environment required
- Previous experience as subject matter expert and training others
- Existing knowledge of equipment in a manufacturing/production environment
Knowledge, Skills, and Abilities:
- Must be able to work within and adapt to electronic systems
- Able to function, with guidance, in a rapidly changing environment while balancing multiple priorities simultaneously
- Must be able to be PAPR and Respirator qualified
- 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)
Physical Demands and Work Environment:
While performing the duties of this job, there may be certain physical demands required for the position.
- Requires constant standing, walking, seeing, & hearing
- Requires occasional sitting
- Requires constant carrying & lifting; frequently under 20 LBS, 20-60 LBS, & occasionally over 60 lbs
- Requires frequent bending, twisting, gripping, & reaching
- Requires frequent pushing & pulling under 20 LBS, 20-60 LBS, & occasionally over 60 LBS
Other Duties:
You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.
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