Technical Specialist – Manufacturing (R-TSMF)
Department: Sterile Filling
Location: Rochester, Michigan
Responsible for facilitating and monitoring product transfer and new technology efforts in the Sterile Manufacturing Operations. This position will work across all four departments in Sterile Manufacturing (Sterile Filling, Bulk D&C, Prep Services and Sanitation). Specific areas of focus in Sterile Manufacturing will be monitoring and reporting departmental operating performance, supporting new technology integration, supporting new product assessment and line trials. This position will both utilize existing systems and create new methods to report departmental operating performance for Sterile Manufacturing. These new methods developed by this position will become efficient tools which can be transferred to and used by supervisory and managerial colleagues. In partnership with the site leaders this position will support a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations.
- Develops strong awareness of departmental operating performance metrics and related support systems (QAD, PAT, shift reports, etc.).
- Enhance existing/develop new mechanisms for assessing and reporting departmental operating performance. Transfers this information/mechanism to Sterile Manufacturing supervision for use in operational optimization activities.
- Develop and cultivate strong relationships with relevant Supply Chain/Logistics colleagues to facilitate flow of timely operating performance information.
- Surveys industry to maintain an awareness of new technology. Initiates and facilitates integration of new technology in operating areas.
- Participates in and facilitates new product assessments. This facilitation to be a single point of contact for Sterile Manufacturing in new product introduction assessments.
- Develop and cultivate strong relationships with relevant Pharm Tech, Business Development and Maintenance and Engineering colleagues to facilitate flow of timely information to support new products.
- Coordinates and facilitates line trials as needed to support new technology and new products.
- Participates in meeting, seminars, programs and other activities designed to have a positive effect on employees, company, and department objectives and responsibilities.
- Collaborates with peers and support groups to obtain maximum quality and efficiency of Sterile Manufacturing.
- Prepares a variety of reports including operating performance, technology assessments, new product assessments/line trials, etc. and submits on a timely basis.
- Keeps Sterile Manufacturing Director informed of all operations.
- Establishes and Maintains Effective cross functional relationships.
Required Education / Experience:
A BS/BA in engineering, or other discipline related to the work area and two years of experience in a manufacturing, laboratory, or other related environment, OR, an equivalent combination of education and experience.
Desired Education / Experience:
Experience in a sterile manufacturing facility, knowledge of equipment, familiarity with manufacturing processes, mechanical aptitude, knowledge of cGMPs and knowledge of OSHA regulations.
If you possess the required background and are interested in being a member of this growing company, submit your resume and cover letter by mail or apply online:
MCP Pharmaceuticals LLC HR Department, Job Code SAS 870 Parkdale Road Rochester, Michigan 48307
To apply for this position, please Apply Online
About MCP Pharmaceuticals, LLC:
MCP Pharmaceuticals is an integrated specialty healthcare company that specializes in sterile injectable products. MCP manufactures and sells brand aseptic injectable pharmaceuticals in hospital and clinical settings and provides contract manufacturing services for global pharmaceutical companies. MCP’s own product portfolio includes leading diagnostic, women’s health and anesthesia products. All products have a long track record of “gold standard” service and are at or near the front line of treatment in their therapeutic indications. Contract manufactured products include some of the leading global biologic products which involve liquid, lyophilized and suspension presentations.
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