Process Engineer I, Drug Product
Process Engineer I, Drug Product
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Salary Not Disclosed
1 Vacancy
Job Description
The Role
In this role you will be a key technical contributor responsible for the ownership operability and reliability of GMP Drug Product manufacturing process equipment at Modernas clinical drug product facility. This role supports component preparation formulation aseptic filling inspection and packaging activities. The engineer is accountable for ensuring equipment readiness supporting deviation investigations and driving continuous improvement while maintaining compliance with GMP standards. Success in this role requires strong cross-functional collaboration technical aptitude and a floor-focused mindset to ensure sustained operations and right-first-time execution.
Heres What Youll Do
System Ownership & Equipment Support
Serve as the System Owner for Drug Product process equipment including formulation filling inspection labeling and packaging systems.
Ensure equipment compliance availability and readiness through proactive support and lifecycle management.
Own and maintain assets in CMMS including maintenance strategy spare parts and workflow coordination.
Deviation CAPA & Change Control Management
Lead or support deviations CAPAs and change controls related to process equipment.
Conduct equipment troubleshooting root cause analysis and implement corrective/preventative actions.
Support alarm and out-of-specification response and assessment processes.
Project & Continuous Improvement Support
Support start-up commissioning and qualification activities for new process equipment and upgrades.
Collaborate with project teams on development of URSs design reviews FAT/SAT and equipment installation.
Identify and lead equipment/process improvements aligned with site and operational objectives.
Documentation & Compliance
Maintain Engineering Turnover Packages (ETOPs) including equipment specifications drawings and manuals.
Ensure technical documentation is current inspection-ready and aligned with GMP expectations.
Author and revise SOPs and other documents as needed.
Cross-Functional Engagement
Collaborate closely with Manufacturing MS&T Facilities Quality and EHS to deliver operational support.
Actively participate in campaign planning readiness reviews and operational floor activities.
Represent Engineering in audits inspections and cross-functional forums.
Additional duties as may be assigned from time to time
Heres What Youll Need (Basic Qualifications)
Education: Bachelors degree in Engineering (Mechanical Electrical or other relevant life sciences field)
Experience: Up to 2 years of engineering experience in a pharmaceutical/biotech manufacturing environment
Heres What Youll Bring to the Table (Preferred Qualifications)
Familiarity with aseptic filling inspection and packaging equipment preferred
GMP/GxP exposure desirable
Knowledge of GMP regulations for parenteral manufacturing
Proficiency with technical writing deviation/CAPA systems and equipment troubleshooting
Strong interpersonal skills with ability to work across functions and drive results
Competency in MS Office tools (Excel Word PowerPoint)
A desire to make an impact as part of a high-growth transformational company that is Bold Relentless Curious and Collaborative.
This position is site-based requiring you to be at Modernas site full-time. This position is not eligible for remote work.
At Moderna we believe that when you feel your best you can do your best work. Thats why our US benefits and global well-being resources are designed to support youat work at home and everywhere in between.
- Best-in-class healthcare coverage plus a suite of voluntary benefit programs to support your unique needs
- A holistic approach to well-being with access to fitness mindfulness and mental health support
- Lifestyle Spending Accounts to personalize your well-being journey
- Family planning and adoption benefits
- Generous paid time off including vacation volunteer days sabbatical global recharge days and a discretionary year-end shutdown
- Savings and investment opportunities
- Location-specific perks and extras
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 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 persons 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 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
Were 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 .
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 applicants 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.
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Employment Type
Full-Time
