The Role: ModernaTX, Inc. seeks a Sr. Engineer, Commissioning, Qualification, and Validation for its Norwood, Massachusetts location. Here’s What You’ll Do: Manage the commissioning, qualification, and validation activities for the company’s Good Manufacturing Practices (GMP) manufacturing facility. Ensure the validated status of site facilities, utilities, equipment, and processes is established and maintained in accordance with internal procedures, regulatory requirements, and industry guidance and standards. Track and report status on metrics relevant to the re-qualification program activities and responsibilities, and ensure commitments to key stakeholders are met. Own quality records such as Change Controls, Deviations, Corrective and Preventative Actions (CAPAs), and continuous improvement initiatives related to validation activities. Lead investigation and review deviation investigations related to manufacturing process equipment, utilities, automation, computer systems, validation, and laboratory instruments. Provide validation subject matter expertise and support for equipment and systems in use, including Controlled Temperature Units such as Refrigerators, Freezers, Incubators; Analytical Instruments used for in-process and quality control testing; and Manufacturing Unit Operations including Ultrafiltration, Chromatography, Mixers, Tanks and Vessels, and Bioreactors and Fermenters, among others. Participate in multi-functional department teams for validated process, equipment, utilities, method, and computer systems, to meet established timeframes for project implementations that support business needs and meet global regulatory requirements. Participate in continuous quality system improvements and support implementing improvements in the GMP Validation and Change Control Programs. Review deliverables by contractors and consultants in the day-to-day execution of Commissioning, Quality and Validation (CQV) scope, and manage contractor priorities. Drive results by owning and completing validation initiatives and projects against identified timelines. May telecommute up to 30%. Here’s What You’ll Bring to the Table: Minimum requirements: Requires at least a Bachelor’s degree in Pharmaceutical Sciences or related life science field and 5 years of progressive post-baccalaureate experience in the position offered or as Senior Validation Engineer, Validation Engineer, CQV Engineer or related position in a cGMP manufacturing environment. 5 years of experience must include: Writing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) Protocols and Reports; Authoring Validation-related Change Controls, Deviations, and Investigations; Executing Validation activities across various projects; Applying Continuous Improvements to periodic review and requalification programs; and Applying manufacturing equipment knowledge to understand and develop testing requirements. May telecommute up to 30%. The salary range for this role is $130,800 to $209,400. This range reflects the lowest to highest salary we, in good faith, believe we would pay for this role at the time of this posting. The minimum target pay for this particular position, based on its primary location, is $170,000 to $209,400. An individual’s placement within the range will depend on several factors, including but not limited to specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. Apply at https://modernatx.wd1.myworkdayjobs.com/en-US/M_tx (Job ID: R19528) or email resume and cover letter to careers@modernatx.com with subject line: R19528. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between. Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs A holistic approach to well-being, with access to fitness, mindfulness, and mental health support Family planning benefits, including fertility, adoption, and surrogacy support Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investment opportunities to help you plan for the future Location-specific perks and extras The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. #dni Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between. Competitive healthcare, plus voluntary benefit programs to support your unique needs A holistic approach to well-being, with access to fitness, mindfulness, and mental health support Family planning benefits, including fertility, adoption, and surrogacy support Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investments to help you plan for the future Location-specific perks and extras The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home