Posted on: May 15, 2022
Job SummaryThe Quality 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 Avantor as part of the Global Compliance
Team.LOCATION: This position will be Onsite in Solon, OHMAJOR JOB
DUTIES AND RESPONSIBILITIES
- Responsible for crafting, 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 company Quality
Management System, along with providing technical expertise within
those functional areas.
- Responsible for developing and implementing 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.
- Designs, authors, and aids in the execution of validation
protocols. Authors process validation protocols and report, along
with developing and maintaining validation metrics.
- Responsible 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. Maintain
Revalidation Plan and all manufacturing, while ensuring all
revalidation is performed and reported.
- 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.
- Work with Design Engineering on Impact Assessments, GAMP and DQ
assessments for all equipment with appropriate guidance from the
Users and Quality Assurance.
- Make proposals and implement actions as part of the continuous
- Lead all aspects of Production Operators and QC analysts during
validation studies and present to Regulatory and Customer
- B.A. or B.S. degree, preferably in life sciences field
- 8+ years applicable experience preferably in a pharmaceutical,
biopharmaceutical or IVD industry
- 3+ years leadership experience, with project management
experienceKNOWLEDGE SKILLS AND ABILITIES
- Knowledge of cGMPs or equivalent regulations
- Ability to make sound decisions about scheduling, allocation of
resources, and balancing priorities
- Strong digital literacy required: shown understanding of
Minitab; functional knowledge of Microsoft Outlook, Word, and
- Proven 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 craft, implement and analyze manufacturing process
- Ability to implement the Validation Plans for medical device
and related product manufacturing equipment and
facilities.ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT
- Typically works in an office environment with adequate lighting
and ventilation and a normal range oftemperature and noise level.
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.
- Work assignments are diversified. Examples of past precedent
are used to resolve work problems. New alternatives may be
developed to resolve problems.
- 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.
- While performing the duties of this Job, the employee is
occasionally exposed to fumes or airborne particles and toxic or
- Health care insurance (health, dental, vision, and prescription
- Spending and savings accounts: Healthcare savings, flexible
spending & limited purpose flexible spending
- A generous amount of paid time off and paid vacations
- Short and long-term disability coverage
- Paid parental leave, 401k, stock purchase options
- And so much more!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/province, 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 equal
employment opportunity protections, please view the Equal
Employment Opportunity is THE LAW Poster, EEO is the Law Poster
Supplement, and Pay Transparency Non-Discrimination Provision using
the links below.3rd Party Non-Solicitation Policy:By submitting
candidates without having been formally assigned on and contracted
for a specific job requisition by Avantor, or by failing to comply
with the Avantor recruitment process, you forfeit any fee on the
submitted candidates, regardless of your usual terms and
conditions. Avantor works with a preferred supplier list and will
take the initiative to engage with recruitment agencies based on
its needs and will not be accepting any form of solicitation.
Keywords: Avantor, Akron , Validation Manager, Executive , Ashland, Ohio
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