Sr. QA Validation Engineer
Company: Tolmar, Inc.
Location: Fort Collins
Posted on: February 22, 2021
This position has the overall responsibility for performing the
Quality Assurance review and approval of all aspects for
commissioning, qualification, and validation (CQV) of facility,
utilities, manufacturing and packaging equipment, cleaning
validation, and process validation for Tolmar's product
manufacturing sites. The position assures that validation
activities associated with remediation, technology transfers, and
product launches are supported in a timely manner and in compliance
with Tolmar policies and procedures and per the guidance and
requirements of the CFR, ISO and international regulations.--
Essential Duties and Responsibilities
- Provide Subject Matter Expert (SME) support in a fast-paced
production environment with high quality and regulatory
- Provide technical direction for commissioning, qualification
and validation activities of aseptic and semi-solid manufacturing
to ensure compliance with internal policies and procedures, current
industry standards, cGMPs and current regulatory requirements.
- Support, create, write and update validation guidelines,
policies and procedures.
- Develop and update Validation Master Plans for the
manufacturing sites on an as-needed basis.
- Work with Manufacturing Science and Technology (MS&T),
Production, Engineering, Maintenance, and Development departments
to assure that all required documentation is appropriately
developed to support process, cleaning, facilities, aseptic,
- Provide guidance and technical expertise in cycle development
initiatives and activities.
- Provide QA validation support to Dermatology and Aseptic
manufacturing, assess impact to product quality and determine
- Participate in audits and follow up on corrective actions.
- Review and approve validation test protocols, test plans, and
final reports, ensuring that they are in alignment with regulatory
- Conduct and participate in investigative meetings relating to
validation manufacturing test failures. Assess impact of production
- Maintain up-to-date knowledge of cGMP regulatory issues,
particularly pertaining to validation, and ensure that company
validation policies and procedures are updated accordingly.
- Coordinate activities with different cross-functional team
members and execute projects to ensure compliance and maintain
systems in a validated state in a timely manner.
- Perform other related duties as assigned. --Knowledge, Skills &
- Ability to work independently with minimal supervision.
- Organized and able to meet project deadlines.
- Ability to assist in the development of validation
- Thorough knowledge of FDA validation guidelines and industry
best practices, cGMPs, ISO, and EU standards for aseptic
processing, clean rooms and semi-solids manufacturing.
- Knowledge and understanding of aseptic and semisolids
- Ability to work well with employees at all levels.
- Experience in creating and modifying SOP, protocols, reports,
and other GMP supporting documents.
- Computer literacy in Microsoft Office programs, including
Outlook, Word and Excel.
- Effective troubleshooting and problem solving skills.
- Ability to clearly communicate (oral and/or written).
- A valid driver's license and acceptable Motor Vehicle record
may be required. Core Values
- The Sr. QA Validation Engineer is expected to operate within
the framework of Tolmar's Core Values:
- Consistently operate with the highest standards of ethics and
- Take ownership of your actions, success and setbacks.
- Respect each other and understand that honest collaboration is
at the heart of our company success.
- Go the extra mile to make things happen.
- Be committed to all we do and the patients we serve.
- Embrace change with enthusiasm.
- Strive to learn about and understand the needs of customers and
patients, and take action with great speed and efficiency no matter
the task. Education & Experience
- Bachelor's Degree in scientific or engineering discipline
- Eight or more years of experience in the pharmaceutical or
- Six or more years of validation experience, with at least 5
years performing pharmaceutical validation activities.
- Operational knowledge of process, cleaning, aseptic,
semi-solid, and filling/packaging required.
- Includes general office environment conditions, work may
require occasional weekend and/or evening work.
- Includes occasional work in a manufacturing type of
environment, requires gowning to Tolmar Standard Operating
Procedure requirements in addition to aseptic (clean room) gowning.
Qualifications Education Required Bachelors or better in Chemistry
or related field. Bachelors or better in Engineering or related
field. Equal Opportunity Employer/Protected Veterans/Individuals
with Disabilities The contractor will not discharge or in any other
manner discriminate against employees or applicants because they
have inquired about, discussed, or disclosed their own pay or the
pay of another employee or applicant. However, employees who have
access to the compensation information of other employees or
applicants as a part of their essential job functions cannot
disclose the pay of other employees or applicants to individuals
who do not otherwise have access to compensation information,
unless the disclosure is (a) in response to a formal complaint or
charge, (b) in furtherance of an investigation, proceeding,
hearing, or action, including an investigation conducted by the
employer, or (c) consistent with the contractor's legal duty to
furnish information. 41 CFR 60-1.35(c)
Keywords: Tolmar, Inc., Fort Collins , Sr. QA Validation Engineer, Engineering , Fort Collins, Colorado
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