Associate Validation Specialist

Job Description:Job Title: Associate Validation SpecialistDepartment: Technical ServicesLocation: Fort Dodge, IowaAt Fort Dodge Animal Health, a division of Wyeth, we are dedicated to our vision of leading the way to a healthier world for animals. Recognized for our breakthroughs in veterinary medicine and innovative product development, our reputation in the animal-care industry precedes us. More than 3,500 employees keep our reputation strong by bringing us a full range of talent. Wyeth, a Fortune 500 Company and global leader in pharmaceuticals, consumer healthcare, and animal healthcare products, we know that it is our employees 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.RESPONSIBILITIES:· Work with applicable department personnel to gather necessary information for protocol preparation.· Develop assigned validation protocols and prepare all necessary documentation.· Prepare validation packets that include all necessary documentation for protocol execution.· Conduct employee training sessions for applicable personnel prior to protocol execution.· Track validation documentation during protocol execution to ensure all is completed and returned to Technical Services.· Prepare assigned PSRs following complete execution of protocols and receipt of all necessary documentation.· Assist with and/or perform protocol execution when necessary.· Operate necessary test equipment.· Perform analysis of data obtained during protocol execution.· Assist with the completion of assignments to meet major department objectives.· Perform duties as assigned by the Manager(s) or Associate Director of Technical Services.BASIC QUALIFICATIONS:· Bachelor of Science degree in Chemistry, Microbiology or Engineering, or equivalent experience in related field, or a minimum of two years experience in validation.· Must possess basic knowledge pertaining to cGMPs and regulatory validation requirements (e.g. FDA, USDA, EU, etc.).· Ability to travel domestically and internationally (valid passport and driver’s license required).ADDITIONAL QUALIFICATIONS:· Familiarity with pharmaceutical and biological production processes, equipment and utilities.· Excellent verbal and written communication skills.· Ability to learn technical information quickly and communicate that information in a clear, concise way to a broad audience.· Knowledge in areas of validation, which may include:· Process validation· Cleaning validation· Equipment qualifications (IQs, OQs, PQs)· Utility validations · Facility validations· Autoclave and oven validations· Biological processes and equipment (e.g. bioreactors, fermentors, etc.)· Aseptic process validation (e.g. Sterile Media Fills and associated clean room validations and processes)· Validation Master Planning· 21 CFR Part 11: Electronic Records; Electronic Signatures· Ability to adapt quickly to changing project priorities.· Ability to interview content knowledge experts for information pertinent to validation activities and documentation.· Critical thinking and critical analysis.· Ability to effectively train personnel.· Proficient with Microsoft Word, Microsoft Excel and Visio Professional software.Fort Dodge Animal Health, a division of 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, visit our website at http://www.wyeth.com Equal Opportunity Employer, M/F/D/V. Search Firm Representatives: Please Read Carefully. Wyeth, including all of its divisions, 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. Expected Travel Time: None       www.wyeth.com/careers Wyeth is an equal opportunity employer that shares the vision of a diverse workplace. 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.