Validation Cleaning Engineer (R-VCER)
Validation Cleaning Engineer (R-VCER)
Department: Validation
Location: Rochester, Michigan
Position Summary:
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 department management with various Validation Technology responsibilities, such as validation project planning, protocol development and execution, process/equipment modification evaluations, contract customer work, and troubleshooting equipment. Works independently, completing project activities with little or no supervision. Performs the role of the validation project leader.
Plan, write, execute and document validation qualification protocols and final reports. Adhere to and promote current Good Manufacturing Practices (cGMP). Provide technical expertise as necessary to support plant goals. Collaborates with peers. Provides consultation and interface between various departments, as needed. Working knowledge of computer system validations and Part 11 compliance requirements.
Be a part of the Quality / Validation group consisting of 11 professionals supporting an aseptic, sterile pharmaceutical plant of around 300 people. This position is for a Sr. technical person, who has the right technical skills in cleaning/product/process validation and also has the leadership skills to deal with high level management people. This person will have 2 Jr. Validation people reporting.
Validation project manager to design, develop, and effectively implement projects, master plans, and testing studies for product/ process validation and cleaning validation in an aseptic manufacturing environment. Self-motivation, efficiency and accuracy are essential to success in this job. 60% Manage Multiple Validation Projects for Product/Process and Cleaning validation activities.
20% Supervise and Mentor Jr. Validation people working under this position.
20% Internal interface with peer groups such as manufacturing, engineering, IT, Quality, automation, etc.
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Manage multiple validation projects.
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Support various regulatory filing activities – NDA, ANDA and Regulatory Responses.
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Provide technical expertise to cross functional teams in regards to validation of cleaning and process associated with aseptic operations.
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Coordinate new programmatic initiatives in support of projects that result in cost/schedule savings, increased performance or regulatory compliance of manufacturing and quality operations.
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Write validation master plans, protocols, and reports. Participate in validation execution, review and compile resultant data, write and compile validation reports and maintain re-validation oversight.
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Create, review, and track validation and re-qualification activities.
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Apply scientific principles, theories, and risk management concepts in daily validation responsibilities.
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Conduct research into generally accepted industry standards, FDA regulations and guidance and international standard organizations.
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Act as a key member of teams which determine most effective validation approaches, strategies, and acceptance criterion.
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Interact in a team environment with other individuals representing Manufacturing, Engineering, QA, Pharmaceutical Technology, RA, and Project Management.
Minimum Requirements: Education / Qualifications / Certifications:
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Minimum 10 years of experience in cGMP/FDA regulated industry
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Minimum 5 years hands on experience with cleaning/process validation.
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Minimum 2 year of Project Management experience with complete Validation life cycle. Ability to develop master plans, for the Co and work on multiple projects.
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Strong understanding of FDA regulations 21 CFR, Parts 210 & 211 (cGMP), Part 820 (Quality System Regulation).
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Experience presenting/defending validation work during FDA or similar regulatory agencies audits.
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Excellent people and communication skills to work in cross-functional teams.
Preferred:
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Masters or PhD degree
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Broad equipment validation experience for any unit operations such as autoclaves, sterilizers, freeze dryers, filling, packaging, etc.
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Additional validation experience with facilities, utilities, computers, etc.
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Experience in sterile liquid manufacturing plant.
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:
By Mail MCP Pharmaceuticals LLC HR Department (Job Code SAS) 870 Parkdale Road Rochester, Michigan 48307
Apply Online 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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