Description
This position will support Production Operational Units (OSD, OMO, Parenteral, and Gliadel), and PAR&D by providing the experience, technical expertise, leadership, and project management skills required to evaluate, select, procure, integrate, and validate any equipment needed for the current or future production needs of any Production Operations Unit or partner. This position will also support any of it's packaging partners in the prompt evaluation of any issue with equipment or process that does not perform to expectations and provide the expertise to make necessary recommendations resolve the issue.20%: Manage Packaging Equipment Engineering in the installation, testing, qualification, and validation of any required Production Operational Unit equipment. To ensure that all production equipment purchased is installed and validated to meet set production criteria and cGMP standards.
20%: Manage Packaging Equipment Engineering in all aspects of the assessment, evaluation, specification, and procurement of any required Production Operational Unit equipment. To ensure that the best equipment is selected to meet specific production goals, new product initiatives, or marketing objectives for any Production Operations Unit.
20%: Support Production Operation Units and PAR&D by the prompt evaluation and trouble-shooting of any issue or problem with existing Contract manufacturer or packager's equipment, components. To ensure quick resolution to production issues and to improve the efficiency of any Production Operations Unit or any of our Contracting partners both locally and internationally.
20%: Control all aspects of major project management inclusive of contract development, budgeting, planning, scheduling, and execution. To ensure that all aspects of major Production Operational Unit projects are managed and executed within the stated time-line and appropriated budget.
20%: Supervise Packaging Equipment Engineering staff in the execution of project management, production support, and validation activities to meet specific goals and maintain all safety and compliance guidelines. Ensure that tasks of the Packaging Equipment Engineering staff are performed efficiently, effectively, and in a manner that is in alignment with Company Vision.
MUST Have Requirements:
1. A Mechanical or Electrical Engineering Degree
2. 8 to 10 years experience with Pharmaceutical Production Operations, or a high school diploma with advanced technical training and 16 to 20 years experience with Pharmaceutical Production Operations, production processes, and cGMP's.
3.Oral Solid Dose Packaging equipment knowledge to include Bottle Filling, Capping, Labeling, Cartoning and Case Picking.
4.Project Management Experience
5. Computer Skills to include Lotus Notes, Word, Excel, CADD
6. Ability to write Operational and Preventative Maintenance Procedures
7. Detail oriented personality with Pharmaceutical Validation (IQ/OQ/PQ) experience and knowledge.
To find out more about Real please visit www.realstaffing.com