Leads the design, validation and implementation of packaging materials, packaging equipment and systems. Generates and executes experimental plans to characterize, develop and qualify materials and processes. Contributes as technical packaging resource in multi-disciplined project teams.
- Collaborate internally and with vendors to evaluate, select and validate cost effective primary, secondary, and tertiary packaging materials, equipment and machines that meet industry standards for sterile-barrier packaging systems and other packaging systems.
- Technical support for cost reduction or process efficiency and quality improvements through standardization, automation, and risk mitigation.
- Performs project activities consistent with department and corporate goals.
- Tests packaging materials, develops and validates packaging processes to support regulatory approval and introduction of new products to market.
- Requires interaction with multiple departments internally, external material and equipment and laboratory vendors and coordination of multidisciplinary tasks.
- Drafts operating procedures and specifications for equipment and processes.
- Drafts packaging material master part specifications and/or artwork specifications.
- Performs process/product risk assessments and prepares reports according to company procedures.
- Prepares packaging and labeling equipment (IQ, OQ, PQ) and process validation (PV) protocols and performs and coordinates execution and drafts final reports
- Effectively supports Packaging Department to resolve problems with machines, materials, and processes.
Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques, and evaluation criteria for obtaining results. Networks with key contacts outside own area of expertise. Determines methods and procedures on new assignments and may coordinate activities of other personnel (Team Lead).
- Bachelor’s degree in Packaging Technology, Mechanical Engineering, Chemical Engineering, or Biomedical Engineering
- 3-8 years of experience as a Packaging, Labeling, or Validation Engineer in a cGMP regulated environment.
- Experience with packaging and labeling equipment and processes
- Demonstrated experience with material, equipment, and process design and implementation
Desired Experience, Knowledge, and Skills:
- Experience in a cGMP regulated environment
- Experience with medical device or pharma packaging and labeling equipment, processes, and regulations standards and such as UDI labeling FDA, MDR, GS1, ISO
- Experience with sterile barrier packaging system designs from parenteral primary packaging such as sterile syringes, sterile pouch, and thermoformed tray packaging.
- Sterilization packaging processes such as aseptic filling and packaging for terminal sterilization using autoclave, VHP, EtO, Gamma, etc.
- Experience with Package Design Verification and Validation including Packaging Usability, Design Verification and Validation, Transportation and Handling testing, Package quality including sterile barrier testing.
- Demonstrated experience with material, equipment, and process validation according to medical device and pharmaceutical industry standards
- Master’s Degree in Chemical or Packaging Technology / Engineering
- Experience with a Thermoforming, Heat Sealing, Impulse Sealing, Vacuum Flush Pouching. Cartoning, Vision Inspection Systems, and on-line barcode printing and verification and coding,
- Experience with Lean, Six Sigma
- Experienced in Project planning and management
- Effectively plans and manages time and deliver results on schedule.
- Excellent communication skills, both written and verbal; adapts written and verbal communication to the audience; influences the team to achieve goals. Presents information effectively to cross-functional teams of varying expertise and experience.
- Excellent follow-through both with daily workload and long-term projects, operating following general or detailed instructions depending on project scope.
- Possess the ability to be actively involved in trouble-shooting packaging and process problems, coordinating with internal and external teams and resources.
- Track record of increased / diversified knowledge and experiences; demonstrated ambition and learning agility thru stretch roles or assignments
- Initiative to take leadership, ownership and accountability. Drives for results
We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.