Kelly Services Director - Aseptic Manufacturing in Shakopee, Minnesota

Director - Aseptic Manufacturing / Shakopee, MN Area - DIRECT HIRE!!!

Kelly Engineering is currently recruiting for a Director of Aseptic Manufacturing in the Shakopee, MN area. This position is responsible for directing and managing all Aseptic Manufacturing activities. They will ensure aseptic products are manufactured in accordance with applicable regulations, policies and industry standards. Individual will be responsible for the following:

•Direct all Aseptic Manufacturing activities. This includes production scheduling, maintaining trained staff and basic budgeting responsibilities.

•Train personnel and complete timely performance evaluations.

•Final manufacturing responsibility for all related documentation.

•Ensure Design Control criteria are met for all manufacturing processes and products.

•Review processes for conformance to regulatory requirements.

•Ensure existing manufacturing systems are compliant and meet demands of production forecast.

•Identify and implement process improvements: decrease human error potential, increase efficiency, and keep up to date on current technology.

•Interpret and apply regulatory and industry standards to processes and products.

•Establish consistent processes for reproducible system control.

•Owner of Change Control for manufacturing process documentation.

•Train personnel on processes.

•Maintain a safe and healthy work environment.

•Demonstrate continuous improvement and promote a progressive quality culture.

•Successfully attain performance period account-abilities established by the employee and their supervisor.

•Successfully attain budget/business objectives.

•Comply with the corporate policies and procedures.

•Comply with regulatory and industry standards.

•Communicate and advocate goals and policies.

•Structure, lead, train, and develop staff for maximum effectiveness.

•Carry out supervisory responsibilities in accordance with the company’s policies and applicable laws. Responsibilities include but are not limited to: planning, assigning and directing work, communicating and appraising performance on an ongoing basis, completion of timely performance reviews, rewarding and disciplining employees, addressing complaints and resolving problems.

•Responsible for compliance to key internal controls (Sarbanes-Oxley Act).

NOTE: This company does not offer H-1B or other work authorization visa sponsorship for this position. Candidates must be legally authorized to work in the United States at the time of hire and maintain work authorization throughout the employment term

Qualified candidates will have the following education/experience to be considered:

Education

•B.S. in Engineering, Science or Business.

•5 + years manufacturing experience in pharmaceutical/medical device preferred

•Minimum 5 years supervisory experience.

•In depth understanding of medical and/or pharmaceutical formulation, filtration, and aseptic filling.

•In depth knowledge and understanding of Current Good Manufacturing Practices (GMP) for drug and device manufacturing.

•Participation in regulatory site inspections.

•Demonstrated technical writing skills (Protocols, Operating Procedures, Preventative Maintenance Procedures, etc…).

•Experience with clean room operations.

•Experience with process systems validation.

•Basic understanding of environmental control (viable and non viable, other particle concerns).

•Proven organizational skills.

•Good technical writing skills.

•Attention to detail.

•Demonstrated ability to maintain proper documentation.

•Knowledge of applicable Drug and Device GMP regulations.

•Knowledge of controlled environments.

•Proven capability in identification and resolution of process problems and opportunities.

•Project Management skills.

NOTE: This company does not offer H-1B or other work authorization visa sponsorship for this position. Candidates must be legally authorized to work in the United States at the time of hire and maintain work authorization throughout the employment term