Packaging Engineer II – TOLMAR Inc. – Fort Collins, CO, USA
Maintains, monitors, and supports the Quality, Safety, Manufacturability, Regulations, Validation, and Testing (i.e. Functional, and Analytical) impacting/influencing the selection of these packaging components: Primary, (i.e. Tube, Syringe, Vial, Bottle, Pump), Secondary (i.e. Carton, Insert, Tray), and Tertiary (i.e. Shippers) and their use for both developmental, and commercial applications.
Essential Duties & Responsibilities
- Work with project team to identify, select, and test primary, secondary, and tertiary packaging components.
- Write technical inspection specifications for packaging components.
- Author/edit Standard Operating Procedures/Work Instructions for various packaging equipment, and processes.
- Coordinate packaging related testing activities, including Physical (i.e. Shipping Studies, Dimensional Testing, Container Integrity) and Analytical (i.e. Extractable/Leachable, USP, FTIR, Sterility) in support of packaging component development.
- Author/edit manufacturing batch records (as they relate to packaging processes).
- Train operations personnel on packaging equipment and processes.
- Author/route/execute/close-out validation protocols and reports on all assigned packaging equipment and processes.
- Support and lead investigations, customer complaints, and related corrective and preventative actions (CAPA).
- Support packaging equipment selection for new or existing products and processes.
- Support retrofit requirements for packaging equipment, and manage related validation requirements for necessary changes.
- Conduct factory acceptance testing (FAT) on new packaging equipment.
- Assist in the research/selection of new packaging equipment.
- Work with outside vendors on the development of new packaging components/labeling.
- Compile annual budgets for assigned products/projects to be reviewed by Packaging Engineer Supervisor/Manager.
- Support in organization/routing of Capital Expenditure Approvals (CEA), Purchase Requisitions and Inventory Requisitions required for assigned products/projects.
- Demonstrate sound and effective technical development and evaluation skills for packaging components, equipment, and processes.
- Develop and communicate requirements with packaging component, packaging equipment, and labeling vendors.
- Drive improvement (Quality, Efficiency, Safety) on existing products/processes.
- Draft comprehensive qualification documentation supporting both equipment and process validations (URS, DQ, IQ/OQ, PQ) from both an execution and reporting standpoint.
- Provide support to other Package Engineering colleagues (Level I, II & III) for various projects as required.
- Provide support to other Package Engineering colleagues (Level II & III) in writing and reviewing container closure sections of IND’s, NDA’s, ANDA’s and associated supplements.
- Support a formal cost saving(s) project demonstrating a proven “Return on Investment” (ROI) for a current commercial package or process.
- Provide support to Quality departments auditing of external suppliers as necessary.
- Special projects and other duties as assigned.
Education & Experience
- BS degree in Packaging Engineering or related field.
- A minimum of three years of experience working with primary, secondary, and tertiary packaging materials, equipment, vendors, and regulations, specifically those used in the pharmaceutical (parenteral), medical device or health care industry. A combination of Corporate and Manufacturing level experience preferred.
- Understanding of requirements (GMP, Validation, CFR, etc.) of working within an FDA regulated industry.
Knowledge, Skills & Abilities
- Working knowledge in auto injector devices or Track and Trace – Serialization is a plus.
- Working knowledge of various Primary packaging systems: Bottles, Closures, Jars, Tubes (Aluminum, Laminate), Vials, Syringes, and Pumps specifically those used in the pharmaceutical, medical device or health care industry.
- Working knowledge of various Secondary packaging systems: Labels, Cartons, Inserts, Tray Packs, and Pouches specifically those used in the pharmaceutical, medical device or health care industry.
- Working knowledge of various Tertiary packaging systems: Shippers specifically those used in the pharmaceutical, medical device or health care industry.
- Working knowledge of various logistical impacts (i.e. Palletization, Cold Chain Management, Serialization) of the packaging engineering function.
- Working knowledge of packaging equipment/processes and packaging component vendors equipment/processes.
- Demonstrated skill in successfully coordinating project team members across various departments.
- Effective written and oral communication skills.
- Ability to handle and effectively manage multiple projects of both low and high priority simultaneously.
- Ability to be self-motivated and work effectively both independently and in a team setting.
- Ability to handle ambiguity; does not become ineffective during periods of uncertainty and change.
- Working conditions are in an office, laboratory and manufacturing environment. Occasional weekend and/or evening work may be required.
- Must be capable of lifting up to 35lbs.
- Must posses a valid driver’s license and an acceptable MVR.
- Travel up to 10% of time may be required. (International & Domestic)