Manufacturing Associate III - TekWissen LLC
North Chicago, IL
About the Job
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. This Client's mission is to discover and deliver innovation medicines and solutions that address complex health issues and enhance people's lives.
Position: Manufacturing Associate III
Location: North Chicago, IL, 60064
Duration: 13+ Months
Job Type: Contract
Work Type: Onsite
Job Description:
- Under some supervision manages Production projects including the introduction of new projects and technology into Production, and Manufacturing Improvement.
- Works in concert with peers in other departments to meet project timelines.
- Responsible for tracking the transfer, implementation and monitoring of projects.
- Uses SAP, LIMS, PI, and other systems, programs, and databases to input, verify, monitor and analyse pertinent data.
Responsibilities:
- List up to 10 main responsibilities for the job. Include information about the accountability and scope.
- Transfers methods into Production instructions to allow for successful performance of scheduled campaigns.
- Schedules work tasks, with limited assistance, to support project/campaign timelines.
- Drafts diverse scope and complexity documents.
- Circulates documents to reviewers with limited assistance, responds to comments and questions.
- Manages document review and approval to meet project timelines.
- Directs changeover activities with assistance.
- Exercises judgment within generally defined procedures and practices to determine appropriate action.
- Tracks ongoing problems and gathers information for analysis.
- Analyse 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 on problems of moderate complexity, where analysis of situations requires evaluation of several factors.
- Works under general supervision.
- Follows established procedures.
- Decisions are reviewed for soundness of technical judgment.
- Coordinates activities of sub group 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.
Qualifications:
- List required and preferred qualifications (up to 10).
- Include education, skills and experience.
- 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.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Source : TekWissen LLC
