Equipment Lead: Prep/Fill, Drug Product (2nd shift) - Cook Pharmica
Cook Medical 43 reviews - Bloomington, IN

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To coordinate the correct technical execution of daily operations and cGMP procedures for one line in the parenteral manufacturing area and to provide leadership to ensure equipment and associated production systems operate in a safe, efficient, and quality-oriented manner.

Essential Functions:
Coordinate and provide direct support to equipment set-up, operation, changeover, and troubleshooting activities (vial or syringe filler, isolator, debagger, E-beam, lid removal system, depyrogenation tunnel, equipment washer, autoclave, terminal sterilizer, lyophilizer)
Collaborate with Team Lead to execute line start-up and clearance activities
Ensure proper documentation of equipment activities in the BR and logbooks
Maintain outstanding technical knowledge of packaging-related equipment
Actively monitor machine/line downtime and efficiency information to respond to operational needs
Provide recommendations and implement solutions to resolve equipment and or process problems in a timely manner
Communicate with management throughout operations to remove roadblocks
Collaborate with Team Lead to execute start-up and clearance activities for the line, equipment, and auxiliary equipment
Communicate end of shift status and equipment issues to incoming shift and management for smooth operations transition; ensure consistency in operation from shift to shift
Continuously review batch records and log sheets during production for error or deviation; facilitate corrections; ensure complete documentation at the end of shift

Additional Responsibilities:
Provide on the floor training and other training resources to support formalized technical, safety, and GMP training
Work with Equipment Specialist and Team Lead to improve line performance (quality, efficiency, and uptime)
Assist with the development and improvement of training methods/materials
Provide continuous coaching to develop motivational and team building atmosphere
Identify and facilitate opportunities for team members to learn new competencies
Identify and participate in process improvements for continued success in efficiency and quality; solicit improvement ideas

Address safety issues immediately
Ensure documentation of equipment problems and deviations that occur in the production process
Communicate and provide continuous feedback to associates on efficiency and quality goals
Ensure equipment related SOPs and BRs are understood and followed
Work with management to respond to associates’ performance issues as they arise
Communicate deviations if they arise; work with Quality to investigate and resolve reports; implement corrective actions
Write, review and revise SOPs as required
Identify and report potential hazards either safety or ergonomic

2-year degree in life sciences, engineering, related technical field, or equivalent work experience
2+ years in automated machine operation in a production/manufacturing environment
Will require flexible schedule, to work 12 hour shifts day or night, weekends or holidays
Required to sign a confidentiality agreement

Pharmaceutical or biopharmaceutical equipment experience (operations, maintenance, or engineering) – preferred
Previous leadership experience - preferred
Very strong mechanical skills with solid information technology background
Excellent communication, teamwork and technical writing skills
Proficient with various/common computer software platforms
Ability to work independently and in teams
Ability to analyze and solve complex problems using both standard problem solving and process improvement tools

Responsible for the manufacture and or packaging of quality products in a timely manner
Responsible for compliance to federal cGMP requirements
Responsible for compliance of Corporate Code of Conduct
Responsible for compliance to company’s Quality Policy Manual
Responsible for compliance with company’s safety policies
Responsible for knowing and adhering to policies and procedures in the company’s Employee Handbook
Responsible for training compliance on all job related SOP’s

Must be able to lift/push/pull up to 50 pounds on a consistent basis
Work with hazardous chemicals on a daily basis
Perform CIP/SIP/sanitization procedures
Majority of day spent in clean rooms requiring gowning
Personal protective equipment including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes may be required in areas associated with this position
Ability to stand for long periods
Must be able to work in an environment that can affect an electronic implant device (i.e. pacemaker, auto injector, etc.)

We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing.

About this company
43 reviews
Belonging to the Cook Medical division of the Cook Group, Cook Incorporated makes thousands of medical devices and related items. Its...