Associate Director, Validations

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, enabling our customers to make the world healthier, cleaner and safer. With annual revenues of $10 billion, we have more than 30,000 employees and serve over 350,000 customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as environmental and industrial process control settings. Serving customers through two premier brands, Thermo Scientific and Fisher Scientific, we help solve analytical challenges from routine testing to complex research and discovery. Thermo Scientific offers customers a complete range of high-end analytical instruments as well as laboratory equipment, software, services, consumables and reagents to enable integrated laboratory workflow solutions. Fisher Scientific provides a complete portfolio of laboratory equipment, chemicals, supplies and services used in healthcare, scientific research, safety and education. Together, we offer the most convenient purchasing options to customers and continuously advance our technologies to accelerate the pace of scientific discovery, enhance value for customers and fuel growth for shareholders and employees alike. All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer. If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific. Thermo Fisher Scientific is an Equal Employment Opportunity and Affirmative Action employer. Job Description Associate Director, Validations Position Summary:  This is a management level position for someone with expertise in validation of equipment, processes and computer systems.  Experience in developing, reviewing, and executing validation protocols is must.  Expertise in validation of equipment and systems related to cold chain management is a plus.   This position requires management skills to organize a team of validation specialists and implement systems to improve efficiency and productivity.   In addition to a technical knowledge base, the ideal candidate must have exceptional interpersonal, managerial and negotiation skills, be highly self-motivated, well organized, and able to develop alternative solutions to validation issues.  Working knowledge of FDA regulations and international validation standards in the FDA regulated industry is essential for this position. Team building, critical analysis skills, conflict resolution, and proven leadership skills are required.   Key Responsibilities: Please list 5-7 key responsibilities of the position.   %1.Manages and supervises a validation and metrology team.  Motivates and provide guidance to employees to effectively and efficiently perform their duties.  20%2.Manages the development, implementation and execution for validation protocols and procedures to ensure equipment and software systems meet appropriate domestic international regulatory agency validation requirements, internal company standards, and client requirements. 15%3.Establishes operational systems to ensure that software and equipment validations are performed in a timely manner.  10%4.Participates in business development activities by reviewing client proposals and identifying validation needs and requirements.10%5.Oversees and reviews validation area processes and procedures, making recommendations for changes and/or improvements.10%6.Trains and coaches employees to excel in the area of expertise.  Evaluates performance and identifies improvement areas, including any training needs. 15%7.Responsible for developing and managing calibration and certification programs.  10%8.Responsible for managing, generating and approving qualification and validation protocols and final reports, change control requests and deviation resolution associated with computer systems, equipment, and utilities.10%  100% Minimum Requirements/Qualifications:  Education/Training –   BS with equivalent experience in FDA regulated industry.  MS or MBA would be a plus. Training in managing validation operations.  Business Experience –   5-7 years of experience in managing validation activities in GMP related industry. 5-7 years of experience in management and supervisory roles Experience in performing equipment, process, utilities, and computer system validations. Experience in cold chain management activities would be a plus.  Knowledge/Skills –   Must have a working knowledge of FDA regulations and industry standards, including 21 CFR 211, 21 CFR 820, 21 CFR 127, and 21 CFR Part 11.   Experience in developing and executing validation protocols such as IQ/OQ/PQ for mechanical, automated, and computer based systems.   Excellent interpersonal skills, problem solving, planning/organization skills, and customer focus. Working Conditions – General      Non-Negotiable Hiring Criteria: (List 3-5 key attributes, skills, or requirements that the candidate must have to be considered for this position)  ·  Experience in developing, executing, monitoring, and managing validation activities in GMP regulated industry.·  Proficient in cGMP requirements as they relate to holding, storing and distributing finished pharmaceuticals and biological specimens.·  Proficiency in application of 21 CFR Parts 11, 210, 211, 820, and 1271.  ·  Proficient with personal computer skills, specifically Microsoft Office applications, with the ability to learn new computer systems quickly.·  Excellent written and oral communication skills.·  Extremely adept in attention to detail/follow up.·  Excellent interpersonal skills, problem solving skills, planning/organization skills, and customer focus.·  Experience in validation of computer controlled systems.  Education: BachelorsJob Level: Director