M
Process Technician
medpharm
Durham · NC · us
15h ago
70%
Strong
Job description
Position SummaryThe 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: NoIndirect Reports: NoKey Relationships (examples: Depts or Individual positions that this position will be working closely with):Quality ControlQuality AssuranceProcess Development/ Formulation R&DFacilitiesTravel requirements:· NoEducation and Experience:A.A.S. in a scientific discipline, or equivalent experience preferred2-4 years’ experience in a cGMP biopharmaceutical manufacturing environment requiredPrevious experience as subject matter expert and training othersExisting knowledge of equipment in a manufacturing/production environmentKnowledge, Skills, and Abilities:Must be able to work within and adapt to electronic systemsAble to function, with guidance, in a rapidly changing environment while balancing multiple priorities simultaneouslyMust be able to be PAPR and Respirator qualifiedAble to work independently and as part of a teamMust be able to read, write and converse in EnglishMust 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, & hearingRequires occasional sittingRequires constant carrying & lifting; frequently under 20 LBS, 20-60 LBS, & occasionally over 60 lbsRequires frequent bending, twisting, gripping, & reachingRequires frequent pushing & pulling under 20 LBS, 20-60 LBS, & occasionally over 60 LBSOther Duties:You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.