Packaging Engineer - Cook Pharmica
Cook Medical - Bloomington, IN

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PURPOSE, OBJECTIVES, FUNCTIONS:
• To support the technical transfer process, batch record generation, investigation, and process improvement for cGMP inspection and packaging of parenteral products.
• To partner with internal groups and external clients to design and implement inspection, label printing, and packaging processes.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Essential Functions:
• Technically support cGMP packaging activities for parenteral products, both ongoing and transferring in new products, including inspection, labeling, and secondary packaging of vials and syringes
• Investigate and recommend corrective/preventive actions for ongoing manufacturing processes
• Plan and participate in manufacturing site audits (cGMP and/or technical) as required
• Generate batch records in coordination with internal and external experts
• Lead/facilitate process improvement activities

Additional Responsibilities:
• Provide on-the-floor technical support to manufacturing
• Manage multiple projects and client interactions with minimal supervision
• Assist with training and implementation of changes to manufacturing processes

AUTHORITIES:
• Identify potential hazards, either safety or ergonomic
• Initiate deviations, work with Quality to investigate and resolve reports, implement corrective actions
• Identify, suggest, and test process improvements

EMPLOYMENT REQUIREMENTS:
• 3-6 years experience in pharmaceutical packaging and thermoforming or a commensurate level of experience with related processes
• BA/BS/MS in package engineering or related discipline or equivalent industry experience
• Requires signing a confidentiality agreement and a non-compete agreement

POSITION QUALIFICATIONS:
• Knowledge of biopharmaceutical regulatory and cGMP requirements
• Excellent problem solving, investigational, and organizational skills
• Knowledge of computer systems including CADD, electronic records, data trending, and evaluation
• Demonstrated ability to work cross-functionally
• Self-motivated and able to work independently
• Possess strong oral and written communication skills

ACCOUNTABILITY:
• Responsible for compliance with the company safety policies
• Responsible for technical transfer of manufacturing process resulting in quality products in a timely manner
• Responsible for compliance with the Corporate Code of Conduct
• Responsible for compliance with cGMP requirements
• Responsible for compliance with the company Quality Policy Manual
• Responsible for knowing and adhering to policies and procedures in the company Employee Handbook
• Responsible for continuous improvement of processes and business practices

PHYSICAL REQUIREMENTS AND ENVIRONMENTAL CONDITIONS:
• Able to work at a computer/in an office setting
• Able to work in classified manufacturing areas
• Potential limited exposure to hazardous chemicals while in manufacturing environment, wearing appropriate personal protective equipment
• Personal protective equipment including safety glasses, lab coat, gloves, specialized clothing including uniform scrubs (pants and shirt) and appropriate shoes may be required in areas associated with this position
• Must be able to lift/push/pull up to 25 pounds
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.

Cook Medical - 19 months ago - save job - block
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About this company
18 reviews
Belonging to the Cook Medical division of the Cook Group, Cook Incorporated makes thousands of medical devices and related items. Its...