Senior Validation Engineer

Saint Charles, IL - USA

Monthly Salary: Not Disclosed

Posted on: 17 hours ago

Vacancies: 1 Vacancy

Job Summary

Job: Senior Validation Engineer

Location: St. Louis MO. This role is not a remote position and will be working on the construction site.

Build Your Future with GBA/Compli

Compli LLC was founded in 2001 to provide Commissioning Validation and Regulatory Support Services to the Life Sciences industry.

We serve pharmaceutical companies across the United States offering a vast array of services that assist companies with exceeding their goals and todays world its never been more important to understand regulations and quality assurance activities as they relate to operations vendors engineering construction and 2020 Compli LLC became a wholly owned subsidiary of George Butler Associates Inc. This acquisition allowed Compli LLC to become part of an integrated network of services where clients have more options to engage an impressive suite of in-house services. Compli is full services Commissioning Qualification Regulatory Compliance and On Demand services firm.

What Youll Do:

Support Client commissioning / validation for facility utility equipment cleaning and process validation projects
Prepare and execute commissioning / validation lifecycle documents
Participate in any stage of clinical or commercial production including green field construction facility renovation new product development product launch or product/process upgrade
Write summary reports for validation and qualification protocols
Support project milestones priorities and deadlines
Write operating procedures for technical equipment and practices and procedures
Perform system and process risk assessments and analyses
Schedule and coordinate protocol execution with other departments including manufacturing facilities and project management
Develop project specific validation plans and strategy
Able to manage and execute multiple projects to meet clients priorities
Provide a practical approach to problem solving
Individuals must represent Compli at client sites and interact confidently with clients contractors management and peers.
Other duties as assigned.

What Youll Bring

Bachelors degree in a related life sciences or requisite industry training and experience
7 years GMP experience
Ability to converse about scientific matters
Ability to work independently or in collaboration with others
In depth understanding and application of validation principles concepts practices and standards
Considered a Subject Matter Expert (SME) in one area of validation

Technical Skills & Abilities:

Proficient in current Good Manufacturing Practices and other applicable regulations
Experienced with all pertinent industry best practices (e.g. ISPE) including development and execution of all applicable system life cycle deliverables (e.g. URS SRS FRS DDS RTM Unit Integration User Acceptance testing FAT SAT Validation Planning IQ OQ PQ Final Validation Summary Report
Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g. EMEA GCP GLP GMP QSR) and internal requirements employing regulatory guidance and industry standards
Excellent written communication skills with emphasis in technical writing
Proficient in Microsoft Word Excel Power Point and Project

Physical Requirements:

Ability to work in on-site/field environments.
Ability to sit stand climb and work on active construction sites for extended periods
Ability to lift up to 25 pounds
Working outdoors in a broad range of climate conditions
Working around construction machinery

Travel: Working on site in St. Louis MO

Join Our Team

If youre a motivated Senior Validation Engineer who takes pride in contributing to safe high-quality projects wed love to hear from you.

Its More Than Just A Job

At GBA we are not your average engineering firm. We are about innovative people who want to solve problems. Were known for our technical excellence but we bring so much more to the table. We strive to create remarkable solutions for a higher quality of life. And we are changing the industry by integrating the design and construction process with use of new technology.

Our people are ambitious passionate and committed to creating high quality imaginative projects. Weve created an environment where we celebrate our teams eagerness to learn and grow. From birthdays and BBQs to protecting the environment and helping families in need GBA employees celebrate and support one another and the communities where we live work and play. Joining our team means youll have rewarding opportunities that challenge and inspire you.

Apply today and build your future with GBA.

At GBA we are an Equal Employment Opportunity Employer promoting diversity in our workforce by including all individuals regardless of age race religion color sex national origin marital status genetic information sexual orientation gender identity gender expression disability veteran status pregnancy status or any other status protected by law.

Required Experience:

Senior IC

Job: Senior Validation EngineerLocation: St. Louis MO. This role is not a remote position and will be working on the construction site.Build Your Future with GBA/CompliCompli LLC was founded in 2001 to provide Commissioning Validation and Regulatory Support Services to the Life Sciences industry.We ...