Senior Validation Engineer

3 weeks ago

New York, United States Millstone Medical Full time

***Relocation assistance and visa sponsorship is not available for this position*** Come join Millstone Medical and become part of a high growth company where you will have the opportunity to learn and grow in an employee-centric culture and see the importance of your work Millstone is a fast growing, fast paced medical service provider for the top Orthopedic companies in the industry. Millstone’s business focus is sterile and non-sterile packaging of medical devices. Millstone also engages in other activities, such as mechanical inspection and assembly, which are designed to meet the outsourcing requirements of medical device manufacturers seeking to reduce costs while maintaining high levels of quality, accuracy, and timeliness. We are FDA and ISO registered and employ a detailed internal quality system to ensure ISO compliance. What's in it for you? A company committed to quality, growth, career pathing. At Millstone, we want you to be your best at work and at home. In addition to competitive compensation, we have designed our Total Rewards Benefits Program to support the physical and emotional well-being of our employees and their families. Total Rewards Benefits Program: Medical - Starting on the 1st day of employment Dental - Starting on the 1st day of employment Vision - Starting on the 1st day of employment Supplemental Benefits - Life, Disability, Critical Illness Paid Time Off Tuition Reimbursement Career Pathing 401(k) with match 1 remote workday per week To learn more about Millstone Medical Outsourcing, please visit us online at www.millstonemedical.com. Responsibilities Include: Document and execute equipment and process validations (IQ, OQ, PQ) on various types of manufacturing equipment and end-of-line processes Creation of manufacturing work instructions Interface with customers on technical issues, project timeline, and validation support Actively participate on cross functional teams to determine the root cause and corrective actions for problems associated with investigations Provide support for operations and communicate with Program Managers Provide training of operations personnel Depending on level of position, could lead projects of moderate scope and duration or independently perform work, which can include creating, maintaining and communicating project or task purpose, scope, schedule, team roles and responsibilities. Plan, schedule and conduct or coordinate detailed phases of the engineering work for projects. Skills Required: Bachelor’s degree in Engineering required Depending on level of position 4-8 years relevant experience Strong technical writing to develop client process validations Excellent communication skills Excellent attention to detail, analytical and problem-solving skills Strong knowledge of statistics Experience with IQ, OQ and PQ protocols Knowledge of GMPs Depending on level of position - Ability to work independently, ability to initiate and manage communications with customer, ability to negotiate with clients regarding projects, timelines, and processes, develop systems to improve standard processes. ADDITIONAL INFORMATION:* Millstone Medical Outsourcing provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status, or any other status protected by applicable federal, state, or local law. All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.

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