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Validation Engineer

Validation Engineer

Leiters IncEnglewood, CO, US
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Job Description

Job Description

Validation Engineer

The Validation Engineer reports directly to the Validation Manager. The role is responsible for acting as a SME for the Commissioning, Qualification, and Validation (CQV) processes for the site. This includes commissioning and qualification of the equipment, process validation, facilities qualification, utilities qualification, shipping validation, and program maintenance. The Validation Engineer will work closely with Quality, Engineering, and Operations teams to ensure processes, equipment, and systems are compliant, reliable, and inspection-ready. This role ensures all systems operate under regulations to ensure the production of quality products for the Company’s 503B cGMP manufacturing facility.

Why Join Leiters Health?

Are you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further – Leiters Health is seeking talented individuals like you to join our dynamic team!

At Leiters Health, we're not just another pharmaceutical company – we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do.

  • Innovative Culture : Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement.
  • Meaningful Work : Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positively impact patients' lives.
  • Professional Development : Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry.
  • Cutting-Edge Technology : Work with state-of-the-art facilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing.
  • Collaborative Environment : Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration.

Who We're Looking For :

We're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today!

Essential Functions :

  • Works on projects / matters in a supporting capacity. Communication may be directed towards the project team and direct management, or the audience may be a wider cross-functional group.
  • Utilizes Project Management skills to plan and coordinate efforts with a cross-functional team.
  • Completes tasks in a timely fashion and communicates task status to management and / or project team.
  • Adheres to GDP / GMP guidelines to author, review, or support technical documents including but not limited to change controls, and CAPAs.
  • Coordination of Validation activities with stakeholders.
  • Supports in writing and executing protocols for Validation work.
  • Identifies and resolves non- conformances / discrepancies encountered during IQ / OQ / PQ execution and work with cross function team to implement mitigation solutions.
  • Generates reports and summarizes results, including confirming the document is suitable to be shared with regulatory agencies.
  • Supports creation or revision of Validation templates for protocols and reports.
  • Supports creation and review of Engineering Documentation (URS, FS, SAT, FAT).
  • Supports project work as a specialist on complex technical matters.

    • Supervisory Responsibilities :

  • N / A

    • Experience and Necessary Competencies :

  • Bachelors degree in STEM field required; i.e. engineering, chemistry, or relevant industry experience.
  • 4+ Years of validation experience preferably in a highly regulated environment.
  • Experience in project management preferred
  • Demonstrated ability to conduct statistical analysis using software (JMP, MiniTab, Saas, etc.)
  • Strong curiosity and willingness to learn, along with the tenacity and drive to see projects through.
  • Willingness to support tasks outside normal job description, as needed. Can-do attitude!
  • Ability to create technical and professional documents.
  • Strong attention to detail and accuracy.
  • Ability to multi-task, with strong organization and time-management.
  • Ability to work under pressure and independently with the ability to make decisions according to established guidelines and accomplish tasks accurately and on a timely basis.
  • Understanding of 503B regulatory requirements, cGMP standards, and USP guidelines is a plus!
  • Proficient written, verbal and oral English communication skills are required.
  • Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel.

    • Physical Requirements :

  • Ability to stand or sit for extended periods of time.
  • Ability to lift, push and pull up to 50 pounds periodically.
  • Ability to maintain a gowning qualification and adhere to aseptic practices.

    • Benefits :

  • 100% employer paid medical plan.
  • Dental & Vision insurance options including FSA & HSA
  • Employer Paid Life Insurance & Employee Assistance Program
  • Short Term & Long-Term Disability Insurance
  • Up to 4% 401K Matching (100% vested on day one!)
  • Generous Paid Time Off Options – vacation, sick, paid leave and holidays!
  • $5,250 Annual Tuition Reimbursement after 6 months
  • $1,000 Referral Bonus Program with no limit
  • Eligible for annual bonus program

    • Timeline :  We will be accepting applications on an ongoing basis until position is filled.

    We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

  • Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.
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    Validation Engineer • Englewood, CO, US