Sr. Validation Engineer

COMPANY DESCRIPTION:  A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here [https://www.youtube.com/watch?v=2rUMvtncuw8].  Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.  At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.  For more information, visit www.Synergbiopharma.com [https://www.synergbiopharma.com/] POSITION OVERVIEW: We are seeking an experienced Sr. Process Engineer to support the development and implementation of a comprehensive terminal sterilization program. This individual will play a critical role in establishing the technical and operational framework for sterilization processes that ensure product safety, regulatory compliance, and manufacturing readiness. The ideal candidate brings deep technical expertise in terminal sterilization methods, strong program development experience, and the ability to collaborate cross-functionally with CQV, engineering, and operations teams to design, implement, and execute robust sterilization solutions. WORK LOCATION: Travel to client sites may be required up to 100%, based on project demands and client expectations.  KEY RESPONSIBILITIES: * Develop and document detailed sterilization process flow diagrams and program architecture * Define sterilization recipes, cycle parameters, and operating ranges * Establish overall sterilization program strategy, standards, and best practices * Partner with CQV, engineering, and manufacturing teams to support execution and implementation * Lead troubleshooting and technical problem-solving during cycle development and start-up * Support commissioning, qualification, and validation activities (protocol development, execution support, deviation resolution) * Ensure compliance with GMP, FDA, and regulatory requirements * Provide subject matter expertise and training to operations staff * Drive readiness for manufacturing operations and sustainable long-term performance QUALIFICATIONS & REQUIREMENTS: Education: * Bachelor’s degree in Engineering, Life Sciences, or related technical field 5+ years of experience in pharmaceutical/biotech or medical device manufacturing environments  Technical Experience: * Demonstrated hands-on expertise with terminal sterilization technologies (e.g., steam, EO, dry heat, or other validated methods) * Experience designing and implementing sterilization programs or systems at a site or program level * Experience supporting new facility start-ups or program build-outs Knowledge, Skills, and Abilities: * Working knowledge of CQV, validation, and GMP compliance standards Strong documentation, technical writing, and cross-functional collaboration skills * Background in process engineering or validation leadership Familiarity with regulatory inspections and audit readiness * Ability to influence stakeholders and lead multi-disciplinary teams ESSENTIAL FUNCTIONS: Physical Demands:  The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.  Work Environment:  The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.  TOTAL REWARDS PROGRAM: We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.  LEGAL STATEMENT:   Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.

About This Role We are seeking a seasoned Senior Mechanical Engineer to lead the design and development of complex electro-mechanical medical devices. This role is integral to our product development lifecycle, from concept through validation and manufacturing transfer. The ideal candidate will bring deep technical expertise, leadership capabilities, and a passion for innovation in the medical device space.   What You Will Do * May lead the design and development of complex electro-mechanical medical devices and equipment. * Generate expert-level 3D and 2D CAD data. * Develop and integrate high-functioning design prototypes with minimal guidance. * Execute prototype testing plans and ensure compliance with safety standards. * Provide leadership, training, and mentorship to junior engineers. * May direct internal resources and manage external development partners. * May function as the mechanical engineering lead on product development programs. * Ensure compliance with FDA, QSR, and ISO regulations. * Participate in business development activities, including proposal review and client engagement.   Required Qualifications * Bachelor’s degree in Mechanical Engineering. * Must have 4–6 years of relevant work experience in medical device development. * Thorough knowledge of product development and strong understanding of the medical device industry. * Excellent written and oral communication skills. * Strong analytical and conceptual skills with the ability to build functional prototypes. * Ability to solve moderate to complex technical problems. * Ability to solve problems of diverse scope. * Exercises judgment in selecting methods and techniques for obtaining solutions. * Strong ability to manage multiple tasks and projects effectively. * Familiarity with FDA, QSR, and ISO standards. * Ability to work independently with minimal guidance.   Preferred Qualifications * Experience leading cross-functional teams and managing external partners. * Prior involvement in business development or input to proposals. * Advanced CAD proficiency and rapid prototyping experience. * Participation in audits and inspections for medical device projects.   Location * This is a hybrid position based in Providence, RI OR Minneapolis, MN