Senior Validation Engineer
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POST DATE 9/9/2016
END DATE 10/8/2016
JOB DESCRIPTIONValidation Engineer
Alcami is a leading provider of services that encompass the entire process of pharmaceutical drug development from discovery through commercialization. We specialize in analytical chemistry, formulation development, clinical packaging, oral drug delivery and contract manufacturing. The company has experienced significant growth and we have continued to attract the most highly skilled professionals in the industry.
With nearly 800 employees operating out of seven sites in the US and Europe, our combined capabilities include API development and manufacturing are worldly recognized. Come join our team!
ABOUT ALCAMI CORPORATION:
Located in Germantown, Wisconsin, Alcami Corporation is part of the growing southeast Wisconsin biotech/pharma cluster. The area boasts global market leaders in contract pharmaceutical services, and a rapidly growing number of academic incubators. A short drive from Chicago, Madison and Milwaukee, Germantown offers residents a small town quality of life with convenient access to major Midwest cities. Residents enjoy an excellent school district and many local recreation attractions, in addition to national sports teams (Green Bay Packers and Milwaukee Brewers and Bucks), and a vibrant waterfront park community that includes world class art museums and children's museums.
The Validation Engineer establishes validation policies and procedures ensuring compliance with global regulations and company standards.
KEY RESPONSIBLITIES AND DUTIES:
* Works with leaders to schedule and execute validation activities.
* Identifies/resolves validation issues and designs validation test plans.
* Authors and follows up on closure documentation for IQ, OQ and PQ.
* Creates and reviews SOPs and related manufacturing process documentation.
* Performs duties related to Corrective and Preventative Action (CAPA) plans, deviations and Change Control (CC).
* Provides validation, facilities and utilities support for new or modified equipment used to manufacture new active pharmaceutical ingredients.
* Prepares summary, deficiency and discrepancy reports, gap analysis, risk analysis, FMEA and traceability matrices.
* Assists with development of validation master plans, CSV, SDS, URS and design specifications.
We require a Bachelor's degree in Chemical Engineering or related disciple, with coursework in quality and chemistry. Also required is a minimum of four years demonstrated experience in the validation of processing equipment, facilities and support utility systems used to manufacture pharmaceutical products. Must have previous experience with validation of computer automated systems and training in GMP, GLP and GAMP. We also require five years of experience in pharmaceutical equipment, facility, HVAC systems and utility validations. Must be able to design, execute and close validation protocols. Must be knowledgeable with 21 CR Part 11 validation requirements.
Preferred applicants will have previous leadership and/or project management experience. Knowledge in Lean Six Sigma and statistical analysis is beneficial.
Alcami Corporation is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.