Packaging Engineer II – Quality Search – Colorado, USA
The Packaging Engineer II will, under limited supervision, develop the packaging components and packaging system requirements for new and existing products/markets. He, or she will maintain, monitor, and support 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:
- Support the packaging equipment selection process for new or existing products and processes.
- Work with outside vendors on the development of new packaging components/labeling.
- 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.
- Proactively lead and propose changes that will result in measureable improvement (Quality, Efficiency, Safety) on existing products/processes/equipment
- 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 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.
- Compile annual budgets for assigned products/projects to be reviewed by Packaging Engineer Supervisor/Manager.
- Support the initiation/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.
- Lead the management of development activities, communication, and project requirements with packaging component, packaging equipment, and labeling vendors.
- Draft comprehensive qualification documentation supporting both equipment, and process validations (URS, DQ, IQ/OQ, PQ) from both an execution and reporting standpoint.
- Provide support and guidance to other Package Engineering colleagues (Level I & II) for various projects as required.
- Provide support and guidance to other Package Engineering colleagues (Level II) in writing and reviewing container closure sections of INDs, NDAs, ANDAs and associated supplements.
- Proactively initiate and lead a formal cost saving(s) project demonstrating a proven “Return on Investment” (ROI) for a current commercial package or process.
- Support Quality audits of external suppliers as necessary.
- Perform other duties as assigned.
REQUIREMENTS – BACKGROUIND:
Education: Requires a Bachelor’s degree in Packaging or equivalent.
Experience: Requires 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, 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:
- Knowledge of packaging equipment/processes and packaging component vendors equipment/processes.
- Extensive 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.
- Extensive 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.
- Extensive working knowledge of various Tertiary packaging systems: Shippers specifically, those used in the pharmaceutical, medical device, or health care industry
- Extensive working knowledge of various logistical impacts (i.e. Palletization, Cold Chain Management, Serialization) of the packaging engineering function.
- Demonstrated skill in successfully coordinating project team members across various departments.
- Excellent 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.