Engineering Specialist: Parts Coordination, Drug Product-Cook Pharmica - Cook Medical (Bloomington)

Engineering Specialist: Parts Coordination, Drug Product - Cook Pharmica Job Title: Engineering Specialist: Parts Coordination, Drug Product - Cook Pharmica Job Type: Full-Time Location: Bloomington, IN Minimum Experience Required: 02 Job Description: PRIMARY FUNCTION: • Supports Drug Product manufacturing lines' equipment/parts coordination - including obtaining vendor parts and service quotes, generating purchase requests, creating MES item masters/orders/work flow, monitoring/maintaining parts inventories, and receiving, inspecting, storing, and releasing parts per GMP procedures. ESSENTIAL JOB FUNCTIONS/DUTIES: • Support parts coordination, maintain parts inventories, as required. • Obtain quotes/proposals for parts and equipment. • Receive, inspect, store, and release parts per GMP procedures. • Etch and passivate product-contact and client-owned parts, as required. • Collect associated data (equipment certs, passivation documents, model numbers, as-built drawings, etc.). • Create new part MES Item Masters, orders, and associated workflow. • Assist in generation of CMMS/Maximo asset load sheets. • Support Factory and Site Acceptance Tests (FAT/SAT), as needed. • Assist coordinating equipment/system installations. • Support the CMMS/Maximo (CM/CMR/ADMIN) workflow. • Create, manage and timely close change controls, CAPAs, Deviations. • Create Calibration Specification sheets for new instruments. • Create/Revise Preventive Maintenance checklists, as needed. • Support Failure Mode and Effects Analysis and Root Cause Analysis activities. • Analyze maintenance work order activities and provide recommendations for improving the maintenance program. • Must work and interact effectively with and for others to achieve company goals. • Must meet company attendance requirements. • Must maintain company quality and quantity standards. • Must have effective oral and written communications throughout various levels of the organization. • Ability to work in collaborative and independent work situations and environments with minimal supervision. • Ability to remain calm and receptive in fast paced situations. MINIMUM WORK EXPERIENCE/EDUCATION REQUIRED: • Knowledge of pharmaceutical processes and equipment is strongly desired • Working knowledge of applicable regulatory standards (FDA, CFR, OSHA, EPA, ISME-BPE etc.) • Demonstrated excellent verbal and written communication skills, including technical writing skills • Engineering Technology degree or related discipline or equivalent work experience • 2-4 years of experience with drug product manufacturing unit operations in the pharmaceutical industry preferred • Required to sign a confidentiality and non compete agreement PHYSICAL REQUIREMENTS/WORK ENVIRONMENT: • Must be able to lift/push/pull up to 50 pounds on a consistent basis • Capable of standing for a minimum of 6 hours, stooping, kneeling, climbing • Potential limited exposure to hazardous chemicals • Must strictly adhere to safety requirements. • Must be able to work in an environment that can affect an electronic implant device (i.e. pacemaker, auto injector, etc.) • 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 EMPLOYEE REQUIREMENTS: Sign the non competition and confidentiality agreements. Compliance with all policies of the company including without limitation the Cook Employee Manual, Cook Code of Conduct, Cook Electronic Information Policy, and Cook Pharmica Quality Manual This job description in no way states or implies that these are the only duties to be performed. This position is expected to follow other job related instructions and duties.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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