Manager Validation Engineering - Solon
Posted on: June 21, 2019
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
- Responsible for implementation and ongoing improvement of
validation policies and procedures within the AMRESCO, LLC Quality
- 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
- 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
- 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
- Designs, authors and executes validation protocols in
compliance with the AMRESCO, LLC Quality System and cGMP
- 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
- 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 email@example.com 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
the Law poster and any supplements, (2) pay transparency
nondiscrimination statement, and (3) if desired, Company EEO/AA
Keywords: Avantorinc-ch, Cuyahoga Falls , Manager Validation Engineering - Solon, Executive , Solon, Ohio
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