Production Manager

Job Duties:

 

• Oversees hourly operators in execution of daily work; assures technicians comply with validated parameters and standard operating procedures.
• Develops daily/weekly department work schedules, set priorities and verifies availability of resources.
• Responsible for schedule adherence; participates in scheduling meetings with the objectives of increased resource utilization.
• Responsive to changes in daily workflow and schedule; determines needs and redeploys resources and/or overtime to achieve delivery and customer service commitments; adapts to ebb/flow of production process including changes due to unplanned maintenance or events requiring investigation.
• Ensures all equipment is working properly.
• Reviews and releases batch record documentation. Ensures people and processes comply with Good Manufacturing Practice (GMP)s, company procedures as per ISO 13485.
• Initiates, and/or reviews department standard operating procedures to support business and quality objectives.
• Completes in-process, set up checks and verification of manufactured product with Standard Operating Procedures.
• Understands and adheres to good documentation practices (GDP).
• Executes Quality Management System assignments (CAPA, Deviation, Change Control, Standard Operating Procedures etc.) to on-time closure.
• Obtains knowledge and executes assignments in QMS areas: deviation management and/or change control.
• Conducts investigations for cause, determines corrective action, and impact; writes reports and assures timely closure.
• Initiates and executes change control assignments in support of continuous improvement initiatives for equipment, documentation, or processes.
• Initiates work orders for equipment repairs or modifications.
• Creates, reviews and conducts technician training programs and assures training is conducted on SOPs, cGMP, and safety.
• Assure and assist classroom and hands on training for batch records, SOP's, and cGMP's, and maintain proper documentation to ensure compliance.
• Follow and comply with company Safety policies and OSHA Regulations.
• Participates in development & maintenance of a safe manufacturing environment. Establishes methods in compliance with regulatory, plant, and corporate policies. Participates in safety meetings, investigates accidents, and takes appropriate corrective action to eliminate hazardous conditions.
• Reports production updates and progress to team and supervisor during meetings.
• Assures hourly technicians comply with all procedures, GMP regulations, safety, and provides constructive feedback.
• Keeps supervisors informed of operations; elevates as needed.
• Reviews operational performance; drives improvement opportunities.
• Counsels, trains, and develops technicians for efficient performance; creates an atmosphere of team effort & open communication.
• Consistently communicate, follow and enforce SOP's and company policies and guidelines.
• Troubleshoots or resolves issues impeding department daily/weekly objectives/deliverables; proactively demonstrates the ownership to achieve.
• Conducts/supports customer audits or regulatory agency inspections.
• Establishes and maintains cooperative cross-functional relationships with peers and leadership in Quality, Operations, Sales, and Supply Chain to meet plant objectives.

 

Job Requirements:

 

Bachelor’s or equivalent degree in Biomedical Engineering, Technology Management, Production Engineering or related technical field and 3 years of relevant manufacturing experience or Master’s or equivalent degree in Biomedical Engineering, Technology Management, Production Engineering or related technical field and 1 year of relevant manufacturing experience.  Experience must include: 

 

• Medical/pharmaceutical manufacturing
• Current Good Manufacturing Practice (cGMP) Regulations for medical/pharmaceutical manufacturing
• FDA 21 CFR Part 820 and ISO 13485 guidelines for medical/pharmaceutical manufacturing

 

Ability to travel up to 15% domestically.