Validation Engineer – Validation (R-VAEI)
Location: Rochester, Michigan
Description: In partnership with the site leaders sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations. Assists in validation of equipment; assists in the development of cycles for new processes or equipment; performs testing and documents results for review by site, corporate and governmental review; pursues increased familiarity with equipment in order to authoritatively explain their function and design.
- Establishes and Maintains Effective cross functional relationships.
- Assists with development of validation protocols, performs testing and writes validation reports for various equipment manufacturing processes, and products. Primarily responsible for protocol execution of various types of basic processing equipment and process under the direction of the Validation Manager.
- Analyze data, generate memos and reports concerning above projects.
- Helps to determine process capability of new equipment though execution of approved protocols and assures defined parameters are incorporated into respective operating procedures and batch card records.
- Performs special projects as assigned by department manager.
- Adheres to all company and GMP procedures, along with safety regulations within the plant.
- Provides validation input at new product/process team meetings.
- Assists with validation activities performed by outside validation companies; assures that department and company policies are adhered to.
- Responsible for effectively adopting modern validation techniques, current industry practice, risk management principles, science-based approaches, and a strong process understanding.
Education / Experience Desired:
Bachelor Degree or advance degree in any of the professional engineering disciplines, pharmacy or science related field with a minimum of two years’ experience in pharmaceutical/medical device; or equivalent combination of education and experience.
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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