VALIDATION ENGINEER at Centennial

Job Description

Validation Engineer

AlloSource is a non-profit organization founded in 1994 on a promise to honor and respect the gift of donation by responsibly developing, processing and distributing life-saving and life-enhancing allografts for our communities. Today, AlloSource is one of the largest, most respected tissue banks in the United States. Through our growth weve remained committed to the wishes of donor families, the needs of our surgeon customers, and the hopes of our patient recipients. Our promise of "doing more with life" reflects our unwavering focus on integrity, quality, safety, and respect - today, and into the future.

Summary
Complete the validation activities required to meet company-wide validation requirements and ensure compliance to regulations. These activities include, but are not limited to: validation plan/protocol development, protocol execution, deviation resolution, and validation reports.

Essential Duties and Responsibilities:
1. Writes validation project plans for new processes, equipment, analytical methods and designs.
2. Executes and writes validation plans and protocols to support projects.
3. Support new product development and operational excellence.
4. Ensures stability protocols are completed.
5. Schedules and maintains schedule for the validations needed for projects.
6. Reviews validation work performed by the Validation Associate.
7. Works closely with internal and external customers to communicate validation deliverables and expectations.
8. Reviews work orders for validation needs.
9. Leads Failure Investigations, Nonconformances, Corrective/Preventative Actions and Failure Modes and Effects Analysis (FMEAs).
10. Adhere to and promote proper practices and techniques which are consistent with current operating procedures, training requirements, safety practices and company policies.

Requirements:
2+ years of validation experience.
5+ years of regulatory/quality experience in an FDA regulated environment (21 CFR 1271, 820 or 210/211).
Advanced proficiency in Microsoft Excel, Project and Statistical software.
A Bachelor of Science in engineering or scientific field.
Must have a high degree of initiative, have good judgment and know when to elevate decisions to management.
Advanced computer skills including: Microsoft Office, Project, Excel, Statistical Software.
This position requires a high degree of discretion and judgment in carrying out the job tasks and responsibilities. The incumbent is expected to make decisions based upon knowledge and experience, with safety of customers and the integrity of AlloSource always at the forefront of considerations.
Requires the ability to develop solutions to technical problems of moderate to advanced complexity.

Preferred Experience:
5+ years of validation experience.
7+ years of regulatory/quality experience in an FDA regulated industry (21 CFR 1271, 820 and 210/211).
1+ years of analytical method validation.
ISO 9001 and ISO 13485

AlloSource offers equal opportunity employment to all qualified employees and applicants for employment without regard to race, creed, color, sex, national origin, age, disability or veteran status. Most of our employment opportunities are posted internally for employees consideration. AA EOE

NOTE: For consideration you must submit a resume and meet the minimum requirements. All offers are contingent upon a background check, drug/alcohol screen and specified positions will require a physical evaluation. If you require special accommodations, please contact Recruiting at 720-873-4700.

Job Requirements

Please refer to the Job Description for the qualifications.
Country: USA, State: Colorado, City: Centennial, Company: AlloSource.