Leads diverse process improvement and new manufacturing and packaging process development projects. Acts as technical lead in multi-disciplined project teams. Works on problems of diverse scope where analysis of data is utilized to make timely and effective decisions. Performs design, purchase, validation and implementation of equipment and system used in manufacturing and packaging of medical devices and drug products.
Specific Tactical Responsibilities:
- Identifies opportunities for cost reduction or process efficiency improvements through standardization and automation.
- Collaborate with suppliers to evaluate, select, and validate cost effective raw materials that meet industry standards.
- Develops and manages projects consistent with department and corporate goals.
- Tests equipment and materials, develops and validates processes to support regulatory approval and introduction of new products to market.
- Requires interaction with multiple departments internally, external material and equipment vendors and coordination of multidisciplinary tasks.
- Prepares draft-operating procedures for new equipment and processes and works with Document Control to ensure final processes are implemented through the document mastering process
- Develops/edits material master part specifications and/or artwork specification to meet requirements
- Performs process/product risk assessments and prepares reports according to company procedures
- Prepares equipment (IOQ, PQ) and process validation (PV) protocols
- Works with the manufacturing and packaging departments to perform/coordinate the execution of equipment and process validations according to approved protocols.
Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise.
None; must be able to participate in and lead multi-disciplined project teams.
- Bachelor’s degree in Chemical Engineering, Mechanical Engineering or related field.
- 5-8 years’ experience in a cGMP regulated environment
- Experience with medical device manufacturing / packaging equipment and processes
- Demonstrated experience with material, equipment, and process validation according to medical device and pharmaceutical industry standards
Desired Experience, Knowledge, and Skills:
- Master’s Degree in Chemical, Mechanical Engineering or related field
- Excellent equipment and process troubleshooting skills
- Effectively manage time and deliver results on time
- Excellent communication skills, both written and verbal, with the ability to educate colleagues and customers of change justification, improvement opportunities, and best practices. This includes being comfortable presenting to large groups and management.
- Experience with formulation and filling processes for viscous solutions
- Previous experience with container closure and sterile barrier packaging systems
- Experience with a heat sealing, cartoning, vision systems and on-line barcode printing and coding
- Demonstrated excellent follow-through both with daily workload and long-term projects, operating autonomously with minimal guidance.
- Possess and understanding of workload and be able to self-prioritize.
- Possess the ability to be actively involved in trouble-shooting manufacturing and packaging process concerns by interacting with internal and external teams.
- Strong personal values including honesty, integrity, people development, and drive 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.