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Manager Validation Engineering - Solon

Company: Avantorinc-ch
Location: Solon
Posted on: June 21, 2019

Job Description:

Job Summary The Validation Manager has responsibility for designing and maintaining the validation system and ensuring the appropriate validation policies and procedures are in place within the Quality Management System. The Validation Manager is responsible for ensuring the equipment, manufacturing and testing facilities and utilities serving the facilities are validated and any revalidation studies are performed. The Validation Manager has responsibility for authoring and maintaining the Validation Master Plan for the Production and Quality Control areas of the site and support areas. As part of these responsibilities, the Validation Manager may author and execute validation protocols and validation reports or will review and approve the protocols and reports that are prepared by the validation team. In addition, the Validation Manager may be expected to support global manufacturing and distribution sites within VWR as part of the Global Compliance Team. MAJOR JOB DUTIES AND RESPONSIBILITIES (List in order of importance)

  • Responsibility for designing, maintaining and continually improving the validation system in line with current national and international standards.
  • Responsible for implementation and ongoing improvement of validation policies and procedures within the AMRESCO, LLC Quality Management System.?
  • Provide technical expertise and guidance on validation policies and procedures and the implementation of those within the Operations and Quality Control (QC) functional areas.
  • Designs, authors and aids in the execution of validation protocols.
  • Responsible for developing and executing matrix type validations where applicable for processes and equipment with adequate supporting rationales.
  • Responsible for oversight and execution of validations for production, manufacturing and cleaning processes. Authors process validation protocols and reports.
  • Responsibility for ensuring validation studies of the operations and quality control facilities, the utilities serving the facilities and manufacturing/operations areas, and testing equipment are completed to the required cGMP standards.
  • Summarizes studies and authors validation reports in compliance with the AMRESCO, LLC Quality System and cGMP standards.
  • Prepare and maintain Validation Master Plans for the facility, utility, and equipment to ensure they are all adequately validated for cGMP projects undertaken within the facility.?
  • Manage team members.
  • Maintain the Revalidation Plan for the manufacturing and quality control facilities, the utilities serving the facilities and all manufacturing and testing equipment and ensures all revalidation is performed and reported.
  • Work with Design Engineering on Impact Assessments, GAMP and DQ assessments for all equipment with appropriate input from the Users and Quality Assurance.
  • Make proposals and implement actions as part of the continuous improvement program to improve validation policies and procedures.
  • Supervise Production Operators and QC analysts during validation studies as required.
  • Present the validation policies and procedures and validation studies to Regulatory and Customer auditors as required.
  • Responsible for development and maintenance of department/validation metrics.
  • Designs, authors and executes validation protocols in compliance with the AMRESCO, LLC Quality System and cGMP standards.
  • Performs other duties as assigned QUALIFICATIONS (Education/Training, Experience and Certifications)
  • B.A. or B.S. degree (preferably in Life Science)
  • 8+ years applicable experience preferably in a pharmaceutical, biopharmaceutical or IVD industry
  • 3+ years leadership experience
  • Project management experience KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently)
  • Knowledge of cGMPs or equivalent regulations
  • Ability to interpret and relate Quality standards for implementation and review
  • Ability to make sound decisions about scheduling, allocation of resources, and managing priorities
  • Strong written and oral communication skills
  • Strong computer skills required: working knowledge of Minitab; functional knowledge of Microsoft Outlook, Word, and Excel.
  • Demonstrated knowledge and experience with software systems and integration with the quality system.
  • Ability to analyze, investigate and propose approaches to technical and regulatory issues.
  • Ability to design, execute and analyze manufacturing process validation studies.
  • Ability to manage multiple concurrent tasks/studies.
  • Ability to execute the Validation Plans for medical device and related product manufacturing equipment and facilities. ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions) Typically works in an office environment with adequate lighting and ventilation and a normal range of temperature and noise level. Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems. A frequent volume of work and deadlines impose strain on routine basis.? Minimal physical effort is required. Work is mostly sedentary but does require walking, standing, bending, reaching, lifting or carrying objects that typically weigh less than 10 lbs.? Although the associate primarily works in an office environment, while performing the duties of this job, the associate is exposed to a production environment. The associate may work near moving mechanical machinery and/or vehicles and the noise level in the work environment can be loud. While performing the duties of this Job, the employee is occasionally exposed to fumes or airborne particles and toxic or caustic chemicals. DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer. EEO Statement We are an Equal Employment/Affirmative Action employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state, or local law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. For more information about our commitment to equal employment opportunity, please Privacy Policy (Links to (1) EEO is the Law poster and any supplements, (2) pay transparency nondiscrimination statement, and (3) if desired, Company EEO/AA Statement

Keywords: Avantorinc-ch, Cuyahoga Falls , Manager Validation Engineering - Solon, Executive , Solon, Ohio

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