Engineer II, Process Engineering, Filling Operations

Initial Therapeutics, Inc.; Norwood (MA); On-site; USD 74,000 - 118,000; Full time

Benefits offered by this job

Healthcare

Well-being programs

Family planning benefits

Paid time off

Retirement planning

Job summary

Moderna seeks a Process Engineer II to support aseptic filling, visual inspection, and secondary packaging at the Norwood, MA site. You will provide day-to-day engineering support to keep manufacturing safe, compliant, and reliable.

This hands-on role focuses on equipment reliability, process optimization, and operational excellence while developing technical expertise under senior engineers’ guidance. Cross-functional collaboration with Manufacturing, Quality, MS&T

Qualifications

• Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, or related discipline.
• Typically 2–5 years of GMP pharmaceutical manufacturing or equipment engineering experience.
• Experience supporting manufacturing equipment in regulated environments.
• Strong troubleshooting and analytical problem-solving skills.
• Ability to work effectively in a fast-paced, cross-functional manufacturing environment.
• This position is site-based in Norwood, MA and not eligible for remote work.

Responsibilities

• Support process and equipment ownership for aseptic filling lines, isolators/RABS, formulation skids, and packaging equipment.
• Monitor equipment performance using KPIs such as OEE, downtime, rejects, and recurring events.
• Support preventive maintenance optimization, spare parts identification, CMMS updates, and lifecycle documentation.
• Participate in equipment inspections and recommend improvements to enhance reliability.
• Troubleshoot equipment and process issues during manufacturing.
• Support deviation investigations, root cause analysis, and CAPAs.
• Assist with change controls and equipment validation activities.

Skills

Troubleshooting

Problem-solving

Cross-functional teamwork

Analytical skills

Education

Bachelor's in Mechanical/Chemical/Biomedical Eng

Tools

Maximo CMMS

Electronic batch records

IQ/OQ/PQ protocols

Job description

The Role

As a Process Engineer II supporting aseptic filling, visual inspection, and secondary packaging operations at the Norwood, MA site, you will provide day-to-day engineering support to ensure safe, compliant, and reliable manufacturing operations. Working closely with Manufacturing, Quality, MS&T, Validation, Automation, and Facilities, you will troubleshoot equipment issues, support investigations, execute continuous improvement initiatives, and participate in equipment qualification and lifecycle management within a GMP environment.

This position is hands‑on and focused on equipment reliability, process optimization, and operational excellence while developing technical expertise under the guidance of senior engineers.

Here’s What You’ll Do

Equipment Support & Reliability

• Support process and equipment ownership for aseptic filling lines, isolators/RABS, formulation skids, component preparation equipment, visual inspection systems, labeling, packaging equipment, and supporting utilities.
• Monitor equipment performance using reliability and operational KPIs including OEE, downtime, rejects, and recurring equipment events.
• Support preventive maintenance optimization, spare parts identification, CMMS updates, and equipment lifecycle documentation.
• Participate in equipment inspections and recommend improvements to enhance reliability.

Troubleshooting & Investigations

• Troubleshoot equipment and process issues during manufacturing.
• Support deviation investigations, root cause analysis, and implementation of corrective and preventive actions (CAPAs).
• Utilize structured problem‑solving tools including 5-Why and Fishbone analysis to identify equipment and process improvements.
• Collaborate with cross‑functional teams to resolve manufacturing issues while minimizing production impact.

Automation & Process Improvements

• Support equipment recipe changes, parameter optimization, and automation improvements through approved change control processes.
• Analyze equipment performance and production data to identify trends and opportunities for improvement.
• Assist with implementation of process improvements that improve equipment performance, product quality, and operational efficiency.

Qualification & Projects

• Support commissioning, FAT/SAT, IQ/OQ/PQ, and equipment validation activities.
• Execute assigned engineering projects including equipment upgrades, process improvements, and change controls.
• Coordinate vendor activities during maintenance and project execution.
• Maintain engineering documentation including SOPs, specifications, and technical reports.

GMP Compliance

• Ensure equipment and processes comply with GMP requirements, site procedures and regulatory expectations.
• Support audit readiness activities and assist during internal and external inspections.
• Follow Good Documentation Practices (GDP), ALCOA+, and data integrity requirements.

Operations Support

• Provide on‑floor engineering support during manufacturing operations.
• Develop troubleshooting documentation and standard work instructions.
• Support operator and maintenance training on equipment and process improvements.
• Participate in after‑hours or on‑call support as required.

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

• Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, or a related engineering discipline.
• Typically 2–5 years of experience in GMP pharmaceutical manufacturing, process engineering, manufacturing engineering, or equipment engineering.
• Experience supporting manufacturing equipment in regulated environments.
• Strong troubleshooting and analytical problem‑solving skills.
• Ability to work effectively in a fast‑paced, cross‑functional manufacturing environment.
• This position is site‑based in Norwood, MA and is not eligible for remote work.

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

• Experience supporting aseptic filling, isolators, visual inspection, packaging, or pharmaceutical process equipment.
• Working knowledge of GMP regulations, Annex 1, Good Documentation Practices, and ALCOA+ principles.
• Familiarity with CMMS systems (Maximo preferred) and electronic batch records.
• Experience supporting qualification protocols (IQ/OQ/PQ).
• Basic knowledge of reliability metrics, OEE, and preventive maintenance strategies.
• Experience using structured problem‑solving methodologies such as 5-Why or Fishbone.
• Strong communication, organization, and technical writing skills.
• Proficiency with Microsoft Excel and basic data analysis tools.
• Experience supporting change control and deviation systems is preferred.

Pay & Benefits

• 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 salary range for this role is $74,000.00 - $118,400.00. 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.

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.

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

Export Control NoticeThis 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.#LI-SB2