Manufacturing Process Technologist

Alkermes • Wilmington, OH

16h

About The Position

Support preventive action, development, engineering, and ongoing manufacturing efforts regarding quality and efficiency. Responsibilities Monitor active manufacturing batches, process trends, and floor activities to ensure safe, compliant, and efficient fill/finish operations. Provide real-time technical support and troubleshooting of batch issues, equipment concerns, and process deviations. Lead and support continuous improvement initiatives and change control activities. Support and/or lead non-routine on-the-floor activities including engineering studies, proof-of-concept runs, equipment testing, and safety improvements. Act as a manufacturing liaison with project Planning, Engineering and Technical teams. Develop and maintain process monitoring and trending tools; perform periodic review of data to identify opportunities to improve performance and efficiency Identify unfavorable trends, investigate root causes, and support the development and implementation of corrective and preventive actions. Provides leadership and manufacturing support in investigations, as assigned. Support process and equipment risk assessments to identify risks and weaknesses in new and existing fill/finish processes. Champion projects as they transition into and through the manufacturing areas and provide regular status updates to Manufacturing management. Develop, revise, and implement SOPs and manufacturing documentation in support of new and changed processes. Support Management in authoring and revising GMP documentation, including Master Production Records and operational procedures. Provide technical and administrative support in the authoring and review of engineering and validation documentation. Support Preventive Maintenance activities PM work orders and equipment inspections. Core Competencies Strong knowledge of fill/finish and aseptic manufacturing operations Working knowledge of cGMP regulations Strong troubleshooting, documentation, and communication skills Ability to work cross-functionally in a regulated manufacturing environment Qualifications Qualifications Experienced manufacturing, process development, or engineering in a pharmaceutical setting Needs to have a blend of both technical and operational know-how in a cGMP setting. Dependable, well-organized, efficient worker with good communication skills Experience supporting investigations, deviations, change controls, and GMP documentation systems preferred. Basic Requirements BS Degree preferred or equivalent experience 1-2 years in manufacturing, process development, or engineering in a pharmaceutical setting Physical Requirements Ability to support cleanroom and manufacturing floor operations, including prolonged standing and walking, aseptic gowning, use of PPE, and occasional lifting up to 50 lbs. Must be able to operate manufacturing equipment and meet required medical and vision qualifications.

Requirements

• Strong knowledge of fill/finish and aseptic manufacturing operations
• Working knowledge of cGMP regulations
• Strong troubleshooting, documentation, and communication skills
• Ability to work cross-functionally in a regulated manufacturing environment
• Experienced manufacturing, process development, or engineering in a pharmaceutical setting
• Needs to have a blend of both technical and operational know-how in a cGMP setting.
• Dependable, well-organized, efficient worker with good communication skills
• BS Degree preferred or equivalent experience
• 1-2 years in manufacturing, process development, or engineering in a pharmaceutical setting
• Ability to support cleanroom and manufacturing floor operations, including prolonged standing and walking, aseptic gowning, use of PPE, and occasional lifting up to 50 lbs.
• Must be able to operate manufacturing equipment and meet required medical and vision qualifications.

Nice To Haves

• Experience supporting investigations, deviations, change controls, and GMP documentation systems preferred.

Responsibilities

• Monitor active manufacturing batches, process trends, and floor activities to ensure safe, compliant, and efficient fill/finish operations.
• Provide real-time technical support and troubleshooting of batch issues, equipment concerns, and process deviations.
• Lead and support continuous improvement initiatives and change control activities.
• Support and/or lead non-routine on-the-floor activities including engineering studies, proof-of-concept runs, equipment testing, and safety improvements.
• Act as a manufacturing liaison with project Planning, Engineering and Technical teams.
• Develop and maintain process monitoring and trending tools; perform periodic review of data to identify opportunities to improve performance and efficiency
• Identify unfavorable trends, investigate root causes, and support the development and implementation of corrective and preventive actions.
• Provides leadership and manufacturing support in investigations, as assigned.
• Support process and equipment risk assessments to identify risks and weaknesses in new and existing fill/finish processes.
• Champion projects as they transition into and through the manufacturing areas and provide regular status updates to Manufacturing management.
• Develop, revise, and implement SOPs and manufacturing documentation in support of new and changed processes.
• Support Management in authoring and revising GMP documentation, including Master Production Records and operational procedures.
• Provide technical and administrative support in the authoring and review of engineering and validation documentation.
• Support Preventive Maintenance activities PM work orders and equipment inspections.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level