**Why Us?** We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life. **Job Description Summary** The Validation Engineer I evaluates and performs specified validations leading to the accurate and reliable validation of products, processes, equipment, facilities, and systems; assists/performs development of studies/cycles for new processes; helps troubleshoot product problems related to validation; performs testing and documents results for review by site, corporate and government review. Further responsible for providing supporting protocol rationales/justifications for the chosen validation methodology/approach. Participates in programs to achieve departmental objectives. Records and reports results. Notes unusual results and notifies management for evaluation. Assists with writing validation documents. In partnership with the site leaders, sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations. **Job Description** + Generates commissioning and validation protocols, and summarizes studies to ensure consistency of data production and compliance with manufacturer and Rochester site specifications, with current Good Manufacturing Practices, and national standards + Develop and execute protocols (IQ/OQ/PQ) for equipment, utilities, facilities and computer systems (e.g., HVAC, water systems, autoclaves, environmental control units, sterile fill/finish and, inspection/packaging equipment, Grade A-D areas). + Analyze validation data and prepare summary reports for internal and regulatory review. + Performs sterilization process validations for equipment utilized in the manufacturing of sterile products. + Prepare and maintain Validation Master Plans, traceability matrices, and validation documentation. + Conduct risk assessments and GMP criticality evaluations for systems and processes. + Performs Periodic Reviews and Requalification testing of qualified GMP equipment, facilities, utilities, computer systems and sterilization processes. + Ensure validation activities comply with Good Documentation Practices (GDP) and current Good Manufacturing Practices (cGMP). + Responsible for confirming all communicated validation plans to applicable management + Provides technical assistance in the form of rationales or validation studies to support acceptability of the manufacture of products + Helps to determine process capability of new equipment through execution of approved protocols and assures that defined parameters are incorporated into respective operating procedures + Responsible for effectively adopting modern validation techniques, current industry practices, risk management principles, science-based approaches and a strong understanding of processes and equipment. + Troubleshoots and resolves issues as needed Qualifications Education & Experience _Minimal acceptable level of education, work experience and certifications required for the job_ + Bachelor of Science in Engineering or Science discipline preferred + Zero (0) to three (3) years of combined experience in pharmaceutical (i.e. Validation/QA or R&D), medical device, biotechnology industries or equivalent combination of education and experience Knowledge _Proficiency in a body of information required for the job_ _e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc._ + Proficient in Microsoft Word, Excel, Power Point, Project and other software relevant to the performance of the Job Skills & Abilities _Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing_ _etc._ + Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics. + Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings. + Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information. + Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed. + Diversity - Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; educates others on the value of diversity; promotes a harassment-free environment; Builds a diverse workforce. + Ethics - Treats people with respect; Keeps commitments; inspires the trust of others; Works with integrity and ethically; Upholds organizational values. + Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity. + Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments. + Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality. + Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly. + Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly. + Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time. + Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals. Completes tasks on time or notifies appropriate person with an alternate plan. + Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed. Physical Requirements _Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc._ + Stand + Walk + Sit + Lift + Talk or hear + Work Environment + Wet or Humid + Work near moving mechanical parts + Fumes or airborne particles **_Disclaimer:_** _The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required._ **EEO Statement:** We firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.