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Leiters Health · 1 hour ago

Validation Engineer

Denver Metropolitan Area

Full-time

Onsite

Mid Level

4+ years exp

Leiters Health is a pioneering pharmaceutical company dedicated to delivering high-quality compounded sterile products and outsourced solutions. The Validation Engineer will act as a subject matter expert for the Commissioning, Qualification, and Validation processes, ensuring compliance and reliability of equipment and systems within the company's cGMP manufacturing facility.

Pharmaceutical

H1B Sponsor Likely

Responsibilities

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

Qualification

Validation experienceStatistical analysisProject managementMicrosoft 365CGMP standardsTechnical documentationAttention to detailTime managementCommunication skillsAdaptability

Required

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

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

Proficient written, verbal and oral English communication skills are required

Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel

Understanding of 503B regulatory requirements, cGMP standards, and USP guidelines is a plus!

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

Preferred

Experience in project management preferred

Benefits

Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!)

Flexible Spending & Health Savings Accounts (FSA & HSA) available

Dental & Vision insurance

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

Company

Leiters Health

Leiters Health is a trusted FDA-registered 503B outsourcing provider of high-quality compounded sterile preparations and pharmacy services.

Founded in 1926

Englewood, Colorado, USA

201-500 employees

https://leiters.com/

H1B Sponsorship

Leiters Health has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2024 (1)