Production Manager Position Available In Capitol Planning Region, Connecticut

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 and 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 and 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:

Bachelors or equivalent degree in Biomedical Engineering, Technology Management, Production Engineering or related technical field and 3 years of relevant manufacturing experience or Masters 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 manufacturingCurrent Good Manufacturing Practice (cGMP) Regulations for medical/pharmaceutical manufacturing

FDA 21 CFR

Part 820 and

ISO 13485

guidelines for medical/pharmaceutical manufacturingAbility to travel up to 15% domestically.

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