Senior Validation Specialist I

Job Category: Biotech/R&D/Science Job Description:At Wyeth, we have a vision of leading the way to a healthier world. We've committed ourselves to achieving this vision by making quality, integrity and excellence the hallmarks of our business. A Fortune 500 company and global leader in pharmaceuticals, consumer healthcare, and animal healthcare products, we know that our employees are who keep us on the cutting edge of innovative discoveries and superior customer service. To sustain and enhance our leadership position in the pharmaceutical industry, we continue to recruit, develop and motivate individuals whose skills, values, and work ethic will grow and improve our business. Job SummaryWith proven ability to accomplish projects independently, provides validation engineering of cGMP equipment systems and processes. Based on engineering specifications, performs validation projects that includes authoring protocols, executing validation protocols and writing reports of validation results. Leads the validation activities for large capital projects. Ensures timely resolution of all deviations and changes that occur during the execution phase. Assists in developing validation standards, procedures, and guidelines for the utilization within the Validation department. Will represent the Validation department on cross-functional site teams. Provides guidance to more junior members of the Validation Engineering staff. Job Responsibilities*Leads projects by developing Validation master plans, schedules, resource loading, and other project deliverables as required. Based on engineering specifications, validates large capital and technically complex projects on equipment or processes that includes authoring protocols, executing validation protocols, and writing reports of validation results. *Represent the Validation engineering department to provide Validation Master Planning on primarily large capital projects. Provide technical leadership on cross-functional investigation teams. Assists in writing Regulatory filings and represents Validation in Regulatory audits/inspections. *Leads a cross-functional team in developing Validation best practices, standards, and guidelines, which includes exploring new techniques, methods, and other industry practices. *Review and approve Validation protocols and summary reports generated by Validation staff against standard procedures and policies. Provide guidance to Validation staff writing protocols and final reports. Basic Qualifications*Minimum of a BS degree in a scientific or engineering field. *GMP, Validation Practices/Technical, and Safety.*Minimum of 8 plus years of relevant Validation Engineering experience with a BS Engineering degree and 10 plus with a BS Non-Engineering degree. *Minimum of 6 plus years of relevant Validation Engineering experience with a MS Engineering degree and 8 plus with a MS Non-Engineering degree. Relocation is not available for this position. Wyeth offers competitive compensation and benefits programs, including child-care subsidies, flex-time, business casual attire, educational assistance and professional development programs. For more information and to apply online, please visit us at: www.wyeth.com/careers Wyeth is an Equal Opportunity Employer, M/F/D/V. Search Firm Representatives: Please Read Carefully. Wyeth is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at Wyeth via-email, the Internet or directly to hiring managers at Wyeth in any form without a valid written search agreement in place for that position will be deemed the sole property of Wyeth, and no fee will be paid in the event the candidate is hired by Wyeth as a result of the referral or through other means. Note: Any search agreement entered into with Wyeth prior to January 2004 is hereinafter void. Search firms are essential to the recruitment and staffing efforts at Wyeth and we value the partnerships we have built with our preferred vendors. For this reason, Wyeth has established and regularly maintains a preferred vendor list. Please note that even preferred vendors need to have a written search agreement signed by the Vice President, Strategic Staffing at Wyeth in place for the specific position in order for a fee to be paid for any candidate referrals.Job Experience:See above.Expected Travel Time: None Zip Code :US-NY-Pearl River Leading the way to a healthier world.