Manufacturing Associate II – Operations New Production Introduction Engineer

Under some supervision manages Production projects as Operations New Production Introduction (NPI) Engineer. Responsibilities include the introduction of new projects and technology into Production, manufacturing improvement initiatives, suite, and equipment readiness. Works in concert with peers in other departments to meet project timelines and continues production success through the life cycles of a process.

Responsibilities:

• Works with cross functional team to facilitate NPI process fit; including batch record review, assistance with area engineer to ensure process fit within BU3 manufacturing suites, work with Tech transfer to produce standardized and efficient clinical batch record. Supports established project campaigns as needed.
• Supports BU3 metrics and help establish meaningful KPIs to identify and enable continuous improvement in tech transfer and new product introduction.
• Schedules work tasks, with limited assistance, to support project/campaign timelines.
• Reviews documents with diverse scope and complexity. Manages document review and approval for the operations group to meet project timelines.
• Exercises judgment within generally defined procedures and practices to determine appropriate action. Tracks ongoing problems and gathers information for analysis. Analyze data to develop solutions to general-level problems. Presents a potential solution to management/senior personnel and with assistance creates an implementation plan.
• Applies knowledge, experience, and technical skills to understand specific site objectives, to provide support to Production initiatives, to execute systems and procedures efficiently and compliantly, evaluates systems for improvement potential. Works, within established systems to improve Good Manufacturing Practices (GMP) compliance.
• Works under general supervision. Follows established procedures. Decisions are reviewed for soundness of technical judgment.
• Coordinates activities of subgroup and actively works under other sub-groups. Provides technical direction and training to less senior personnel.
• Frequently interacts with subordinates and functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects, schedules, etc.

•Bachelor’s Degree or equivalent required.
•At least 5 years’ experience in all aspects of manufacturing/production processes with good writing skills.
•Knowledge of media/buffer preparation, cell culture or purification of biological drugs is required for specific biologics sites.
•Computer and scheduling proficiency.
•A working knowledge of safety, quality systems, and current Good Manufacturing Practices as applied to equipment and process steps in area of responsibility is required. Familiarity with pertinent regulatory filings. Proficiency with tech transfer process and familiarity with equipment and facilities validation.
•Must be flexible to handle multiple tasks including ability to handle pressure in a professional manner. Effectively work in a team environment. Maintain high level of energy and professionalism on the job. Build effective working relationships with customers, co-workers, cross-functioned groups, and management.