Engineer II, Validation

Initial Therapeutics, Inc.; Norwood (MA); On-site; USD 72,500 - 116,000; Full time

Benefits offered by this job

Best-in-class healthcare coverage

Holistic well-being programs

Generous paid time off

Job summary

A leading biotechnology firm in Norwood is seeking a Validation Specialist to execute qualification activities in compliance with industry standards. The successful candidate will perform commissioning and validation at a GMP manufacturing facility, ensuring all processes are in compliance. A degree in Life Science or Engineering is required, along with 2+ years of industry experience. This role offers competitive benefits and a holistic approach to well-being, fostering an environment of innovation and teamwork.

Qualifications

• Minimum 2+ years in commissioning, qualification, or validation experience in cGMP.
• Strong understanding of validation principles and regulatory requirements.

Responsibilities

• Perform qualification activities as per CQV program.
• Ensure compliance of systems and equipment.
• Support internal and external audits as part of CQV.

Skills

Commissioning

Qualification

Validation

Quality documentation generation

Interpersonal skills

Education

B.S. in Life Science or Engineering

Master’s degree in relevant field preferred

Job description

The Role

In this role, you will perform the duties according to the Moderna Commissioning, Qualification and Validation (CQV) program and execute assigned qualification activities. This role will own the delivery of the capital projects, site re-qualification and periodic review programs, ensuring systems and equipment remain in an operational state of compliance.

Here’s What You’ll Do

• Perform commissioning, qualification, and validation activities for Moderna’s GMP manufacturing facility which includes raw material, Drug Substance, Formulation, Drug Product, Finished Goods, and personalized medicine capabilities.


• Working with external validation service providers. Responsibilities and ensure commitment to key stakeholders are met.


• 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 / standards.


• Support new equipment qualification activities for capital and operational projects.


• Assist investigation and reviews deviation investigations related to manufacturing process equipment, utilities, automation, computer systems, validation, and laboratory instruments.


• Provide support for equipment and systems in use at Moderna facilities (Controlled Temperature Units [Refrigerators, Freezer, Incubators], Analytical Instruments [used for in-process and quality control testing], Manufacturing Unit Operations [Ultrafiltration, Chromatography, Mixers, Tanks / Vessels, Bioreactors / Fermenters], etc.).


• Support internal and external audits/inspections as a part of Commissioning, Qualification and Validation program.


• Participate in continuous quality system improvements and supports implementing improvements in the GMP Validation and Change Control Programs.


• Drive results by owning and completing validation initiatives / projects against identified timelines.


• Own quality records such as Change Controls, Deviations, Corrective / Preventative Actions (CAPAs), and continuous improvement initiatives related to validation activities.


• Additional duties as may be assigned from time to time

Here’s What You’ll Need (Basic Qualifications)

• B.S. in Life Science or Engineering Degree (Mechanical, Computer Science or Biomedical Engineering Etc.). Master’s degree in above discipline preferred.


• Minimum of 2+ years in commissioning / qualification / validation /quality experience in cGMP manufacturing environments

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Strong understanding of validation principles including but not limited to facilities, utilities, equipment, and systems (FUSE).


• Excellent technical documentation generation and review skills ensuring the content is technically sound, adheres to applicable site procedures and is suitable for regulatory submission / inspection.


• Must be able use his / her technical background to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions. Must be able to be able to find true root cause and path forward for complex problems.


• Excellent interpersonal and communication skills (verbal and written) are required. Expected to be able to present own work to peers and cross-functional managers and influence leadership decisions. Technical writing skills required.


• Ability to interact well with other groups and must be able to take ownership of and follow through on assignments. Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his / her manager.


• Ability to represent Moderna’s interests, objectives, and policies in a professional and responsible manner.


• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.


• At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship.

Pay & Benefits

• 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 salary range for this role is $72,500.00 - $116,000.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.

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.

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Our Working Model

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

Moderna is a smoke-free, alcohol-free, and drug-free work environment.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Accommodations

We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [e-mail].

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non‑U.S. persons to apply for an export control license.