The Packaging Engineering Manager leads the development, qualification and maintenance of innovative, compliant and cost-effective packaging designs and packaging processes for the manufacture of new and existing products. This position works cross functionally with R&D, Marketing, Regulatory, Supply Chain, Manufacturing, Packaging and Labeling teams.
- Manages packaging engineering projects including developing budget, assessing resource requirements, working cross functionally to define user requirements, managing activities and schedules and reporting progress versus plan.
- Identifies critical process parameters and input (raw) material attributes that must be controlled to achieve critical material (quality) attributes; uses Risk assessments to prioritize process parameters and material attributes for experimental verification
- Establishes control strategies for the entire packaging process that may include input material controls, process controls and final product tests
- Utilizes Design of experiments (DOE), risk assessment, and process analytical technology (PAT) as tools in the development, qualification and production processes when appropriate
- Generates packaging stability and transportation simulation data according to ISO guidelines that demonstrates packaging and product meet quality attributes in line with user requirements and product shelf life
- Coordinates required reports, specifications and technical documentation for Regulatory submission packets
- Works with manufacturing and packaging to evaluate existing packaging and labeling processes; recommends, designs, and implements process improvements to achieve cost reductions, improved product quality, and increased capacity
- Prepares specifications for new equipment and automation technology, prepares draft-operating procedures and supports validation to coordinate start-up and validation activities
- Responsible for the hiring, professional development and management of staff within the Packaging Engineering function
- Perform other duties as assigned
Works on problems of diverse and highly technical scope requiring critical thinking and interaction with internal and external technical professionals. Exercises broad judgment within defined practices and policies. Requires interaction with multiple departments and coordination of multidisciplinary tasks.
Role may include managing engineers, vendors, contractor and consultants as required. Must be able to lead and influence multi-disciplined project teams.
- Bachelor’s Degree in Packaging, Chemical, Biomedical Engineering or related science / engineering field. Master’s degree can be substituted for up to 2 years’ experience
- 8+ years of packaging engineering experience with demonstrated growth and people management skills
- A thorough understanding of design and qualifications requirements for terminally sterilized sterile barrier packaging according to ISO 11607 and related regulations
- Excellent data analysis skills, and proficient in the use of statistical tools in problem solving
- Working knowledge of Design Controls from concept feasibility through technology transfer and maintenance stages
- Detailed knowledge of equipment and process validation requirements
- Knowledge of quality systems Drug and Device (21 CFR 820 and 21 CFR 210/211)
- Experience with Medical Device Regulation ISO 13485
- Experience identifying and implementing automation with packaging and labeling processes.
Desired Experience, Knowledge, and Skills:
- Comprehensive knowledge of packaging and labeling equipment in medical device and pharmaceutical industry
- Demonstrated proficiency in handling large sets of data including statistical analysis using software packages such as Minitab, JMP, SIMCA, etc.
- Detailed knowledge of multivariate analysis and DoE approaches
- Strong interpersonal and leadership skills
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.