Performs activities for the design, validation and implementation of packaging materials, packaging equipment and systems. Contributes as technical packaging resource in multi-disciplined project teams
- Support projects to implement and evaluate package material changes through coordinating and performing testing and process trials and other qualification tasks.
- Implement cost reduction and efficiency improvement and quality improvement projects, drafting process procedures, materials specifications, test specification documents and training production personnel.
- Performs project activities consistent with department and corporate goals.
- Requires interaction with multiple departments internally, external material and equipment vendors
- Creates and manages in-line imprinting and labeling specifications and printing machine setups and software and creates and routes Artwork Master Labels (AML) specifications for approval for implementation
- Implements and manages label inspection vision systems
- 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 problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive internal/external working relationships.
- Bachelor’s degree in in Packaging Technology / Engineering or related field with related experience
- 2-5 years of experience as a Packaging Engineer in a regulated environment.
- Experience with packaging and labeling equipment and processes
- Packaging Engineering experience in a manufacturing environment
Desired Experience, Knowledge, and Skills:
- Experience in a cGMP regulated environment or other highly regulated environment.
- Experience with medical device or pharma packaging and labeling equipment and processes
- 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
- Previous experience with sterile barrier packaging systems
- Experience with a Thermoforming, heat sealing, cartoning, vision systems and on-line barcode printing and verification and coding, UDI labeling
- Excellent equipment and process troubleshooting skills
- Effectively manage time and deliver results on time
- 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.
- Demonstrated excellent follow-through both with daily workload and long-term projects, operating following general or detailed instructions depending on project scope.
- Plans own work setting realistic timelines and expectations.
- Possess the ability to be actively involved in trouble-shooting packaging and production process concerns by interacting with internal and external teams.
- Track record of increased / diversified knowledge and experiences; demonstrated ambition and learning agility thru stretch roles or assignments.
- Demonstrates initiative to take leadership, ownership, and accountability for difficult or complex challenges. 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.