Manufacturing Associate II (Sunday to Wednesday, 4:00pm - 2:30am)
About The Position
Under some supervision, the Manufacturing Associate II manages Production projects, including introducing new projects and technology into Production and implementing manufacturing improvements. The role works with peers in other departments to meet project timelines and tracks the transfer, implementation, and monitoring of projects. It uses SAP, LIMS, PI, and other systems, programs, and databases to enter, verify, monitor, and analyze relevant data. The position supports Production initiatives and applies technical knowledge to execute systems and procedures efficiently and compliantly, evaluate opportunities for improvement, and strengthen Good Manufacturing Practices (GMP) compliance. Work involves moderately complex problems requiring consideration of multiple factors. The employee works under general supervision, follows established procedures, and has decisions reviewed for technical soundness. The role coordinates subgroup activities, works with other subgroups, and provides technical direction and training to less senior personnel. It also interacts frequently with subordinates and peer groups, including gaining cooperation and presenting technical information about projects and schedules.
Requirements
- Bachelor’s degree or equivalent.
- At least 5 years of experience in all aspects of manufacturing or production processes.
- Good writing skills.
- Computer and scheduling proficiency.
- Working knowledge of safety, quality systems, and current Good Manufacturing Practices as applied to equipment and process steps in the area of responsibility.
- Familiarity with pertinent regulatory filings.
- Proficiency with the tech transfer process and familiarity with equipment and facilities validation.
- Ability to handle multiple tasks and pressure professionally, work effectively in a team environment, maintain energy and professionalism, and build effective working relationships with customers, coworkers, cross-functional groups, and management.
Nice To Haves
- Knowledge of media/buffer preparation, cell culture, or purification of biological drugs is required for specific biologics sites.
Responsibilities
- Transfer methods into Production instructions to support successful scheduled campaigns.
- Schedule work tasks, with limited assistance, to support project and campaign timelines.
- Draft documents of varying scope and complexity; circulate them for review, respond to comments and questions, and manage review and approval to meet timelines.
- Direct changeover activities with assistance.
- Track ongoing problems, gather information for analysis, analyze data to develop solutions to general-level problems, present potential solutions to management or senior personnel, and help create implementation plans.
- Support Production initiatives and execute systems and procedures efficiently and compliantly.
- Evaluate systems for improvement potential and work within established systems to improve GMP compliance.
- Coordinate subgroup activities and work with other subgroups.
- Provide technical direction and training to less senior personnel.
- Present technical information concerning projects and schedules and work to gain cooperation from subordinates and functional peer groups.
- Use SAP, LIMS, PI, and other systems, programs, and databases to input, verify, monitor, and analyze pertinent data.
Benefits
- Paid time off, including vacation, holidays, and sick leave.
- Medical, dental, and vision insurance.
- 401(k).
- Eligible to participate in short-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
