Packaging Engineer-Cook Pharmica - Cook Medical (Bloomington)

Packaging Engineer - Cook Pharmica Job Title: Packaging Engineer - Cook Pharmica Job Type: Full-Time Location: Bloomington, IN Minimum Experience Required: 03 Job Description: 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.

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