Responsibilities Commercial & Clinical Aseptic Manufacturing Support: * Support technical leadership and day-to-day aseptic process engineering support for clinical and commercial drug product ...
Responsibilities Commercial & Clinical Aseptic Manufacturing Support: * Support technical leadership and day-to-day aseptic process engineering support for clinical and commercial drug product ...
Process Engineer III, Manufacturing Sciences & Technology
Lexington, MA · On-site
$105K - $130K/yr
... Engineering, Quality, and Regulatory Affair etc.. JOB RESPONSIBILITIES * Supports downstream processing unit operations for process implementation, data collection, data analysis, and real time ...
Process Engineer III, Manufacturing Sciences & Technology
Lexington, MA · On-site
$105K - $130K/yr
... Engineering, Quality, and Regulatory Affair etc.. JOB RESPONSIBILITIES * Supports downstream processing unit operations for process implementation, data collection, data analysis, and real time ...
Tiffany & Co. operates a manufacturing facility in Cumberland, RI where jewelry products unique to ... The ideal candidate will support process engineering efforts centered on technology and cost ...
Tiffany & Co. operates a manufacturing facility in Cumberland, RI where jewelry products unique to ... The ideal candidate will support process engineering efforts centered on technology and cost ...
Tiffany & Co. operates a manufacturing facility in Cumberland, RI where jewelry products unique to ... The ideal candidate will support process engineering efforts centered on technology and cost ...
Tiffany & Co. operates a manufacturing facility in Cumberland, RI where jewelry products unique to ... The ideal candidate will support process engineering efforts centered on technology and cost ...
Sr. Process Engineer
Bedford, MA · On-site
$109K - $141K/yr
This individual will collaborate closely with engineering, automation, validation, manufacturing ... The Senior Process Engineer will provide leadership in process engineering, system integration ...
Sr. Process Engineer
Bedford, MA · On-site
$109K - $141K/yr
This individual will collaborate closely with engineering, automation, validation, manufacturing ... The Senior Process Engineer will provide leadership in process engineering, system integration ...
Tiffany & Co. operates a manufacturing facility in Cumberland, RI where jewelry products unique to ... The ideal candidate will support process engineering efforts centered on technology and cost ...
Tiffany & Co. operates a manufacturing facility in Cumberland, RI where jewelry products unique to ... The ideal candidate will support process engineering efforts centered on technology and cost ...
Senior Subtractive Manufacturing Engineer, Production Machining
Woburn, MA · On-site
$99K - $136K/yr
This is a thought leadership role for someone who solves hard problems, develops the people around them, and is passionate about engineering manufacturing processes that don't just work in theory ...
Senior Subtractive Manufacturing Engineer, Production Machining
Woburn, MA · On-site
$99K - $136K/yr
This is a thought leadership role for someone who solves hard problems, develops the people around them, and is passionate about engineering manufacturing processes that don't just work in theory ...
Process Engineer IV
Gloucester, MA · On-site
$128K - $176K/yr
Who We Are Applied Materials is a global leader in materials engineering solutions used to produce ... We design, build and service cutting-edge equipment that helps our customers manufacture display ...
Process Engineer IV
Gloucester, MA · On-site
$128K - $176K/yr
Who We Are Applied Materials is a global leader in materials engineering solutions used to produce ... We design, build and service cutting-edge equipment that helps our customers manufacture display ...
Process Engineer IV
Gloucester, MA · On-site
$128K - $176K/yr
Who We Are Applied Materials is a global leader in materials engineering solutions used to produce ... We design, build and service cutting-edge equipment that helps our customers manufacture display ...
Process Engineer IV
Gloucester, MA · On-site
$128K - $176K/yr
Who We Are Applied Materials is a global leader in materials engineering solutions used to produce ... We design, build and service cutting-edge equipment that helps our customers manufacture display ...
... Process Development, Manufacturing ... Engineering, Quality, and Regulatory Affair etc.. JOB RESPONSIBILITIES * Supports downstream ...
Quick apply
... Process Development, Manufacturing ... Engineering, Quality, and Regulatory Affair etc.. JOB RESPONSIBILITIES * Supports downstream ...
Process Engineer III, Manufacturing Sciences & Technology
Lexington, MA · On-site
$105K - $130K/yr
... Process Development, Manufacturing ... Engineering, Quality, and Regulatory Affair etc.. JOB RESPONSIBILITIES * Supports downstream ...
Process Engineer III, Manufacturing Sciences & Technology
Lexington, MA · On-site
$105K - $130K/yr
... Process Development, Manufacturing ... Engineering, Quality, and Regulatory Affair etc.. JOB RESPONSIBILITIES * Supports downstream ...
Manufacturing Engineer - Process Planning
$85K - $100K/yr
Reviews Engineering Change Orders and updates process documentation as necessary. * Collaborates with other manufacturing engineers, design engineers, quality control personnel, supervisors and ...
Manufacturing Engineer - Process Planning
$85K - $100K/yr
Reviews Engineering Change Orders and updates process documentation as necessary. * Collaborates with other manufacturing engineers, design engineers, quality control personnel, supervisors and ...
Manufacturing Engineering Manager
$115K - $143K/yr
This role is focused exclusively on sustaining and continuously improving existing manufacturing processes bybeing hands on with Engineers on the floortroubleshooting,developing mature work cells ...
Manufacturing Engineering Manager
$115K - $143K/yr
This role is focused exclusively on sustaining and continuously improving existing manufacturing processes bybeing hands on with Engineers on the floortroubleshooting,developing mature work cells ...
Process Engineer
Plainville, MA · On-site
This role requires extensive cross-functional collaboration with Process Development, Manufacturing, Engineering, Validation, Quality, Supply Chain, and external partners to ensure successful process ...
Process Engineer
Plainville, MA · On-site
This role requires extensive cross-functional collaboration with Process Development, Manufacturing, Engineering, Validation, Quality, Supply Chain, and external partners to ensure successful process ...
Manufacturing Engineering Manager
Bedford, MA · On-site
$115K - $143K/yr
This role is focused exclusively on sustaining and continuously improving existing manufacturing processes by being hands on with Engineers on the floor troubleshooting, developing mature work cells ...
Manufacturing Engineering Manager
Bedford, MA · On-site
$115K - $143K/yr
This role is focused exclusively on sustaining and continuously improving existing manufacturing processes by being hands on with Engineers on the floor troubleshooting, developing mature work cells ...
Process Engineer
Plainville, MA · On-site
This role requires extensive cross-functional collaboration with Process Development, Manufacturing, Engineering, Validation, Quality, Supply Chain, and external partners to ensure successful process ...
Quick apply
Process Engineer
Plainville, MA · On-site
This role requires extensive cross-functional collaboration with Process Development, Manufacturing, Engineering, Validation, Quality, Supply Chain, and external partners to ensure successful process ...
2nd Shift Process Engineering Technician
Chelmsford, MA · On-site
$31 - $43/hr
Work with Manufacturing Engineering staff to develop new procedures and processes that incorporate design for manufacturing's best practices to improve yield and cycle time metrics. * Support ...
2nd Shift Process Engineering Technician
Chelmsford, MA · On-site
$31 - $43/hr
Work with Manufacturing Engineering staff to develop new procedures and processes that incorporate design for manufacturing's best practices to improve yield and cycle time metrics. * Support ...
Manufacturing Engineering Manager
Bedford, MA · On-site
$115K - $143K/yr
This role is focused exclusively on sustaining and continuously improving existing manufacturing processes bybeing hands on with Engineers on the floortroubleshooting,developing mature work cells ...
Manufacturing Engineering Manager
Bedford, MA · On-site
$115K - $143K/yr
This role is focused exclusively on sustaining and continuously improving existing manufacturing processes bybeing hands on with Engineers on the floortroubleshooting,developing mature work cells ...
2nd Shift Process Engineering Technician
Chelmsford, MA · On-site
$31 - $43/hr
Work with Manufacturing Engineering staff to develop new procedures and processes that incorporate design for manufacturing's best practices to improve yield and cycle time metrics. * Support ...
2nd Shift Process Engineering Technician
Chelmsford, MA · On-site
$31 - $43/hr
Work with Manufacturing Engineering staff to develop new procedures and processes that incorporate design for manufacturing's best practices to improve yield and cycle time metrics. * Support ...
Sr. Process Engineer
Bedford, MA · On-site
$109K - $141K/yr
This individual will collaborate closely with engineering, automation, validation, manufacturing ... The Senior Process Engineer will provide leadership in process engineering, system integration ...
Sr. Process Engineer
Bedford, MA · On-site
$109K - $141K/yr
This individual will collaborate closely with engineering, automation, validation, manufacturing ... The Senior Process Engineer will provide leadership in process engineering, system integration ...
Manufacturing Process Engineering information
See Boston, MA salary details
$54.9K - $62.4K
1% of jobs
$62.4K - $70K
6% of jobs
$70K - $77.5K
13% of jobs
$79.7K is the 25th percentile. Wages below this are outliers.
$77.5K - $85.1K
17% of jobs
The median wage is $90.1K / yr.
$85.1K - $92.6K
19% of jobs
$92.6K - $100.2K
14% of jobs
$103.6K is the 75th percentile. Wages above this are outliers.
$100.2K - $107.8K
11% of jobs
$107.8K - $115.3K
7% of jobs
$115.3K - $122.9K
5% of jobs
$122.9K - $130.4K
4% of jobs
$130.4K - $138K
2% of jobs
$54.9K
$95.8K
$138K
How much do manufacturing process engineering jobs pay per year?
What are some common challenges faced by manufacturing process engineers when implementing process improvements?
What is the difference between Manufacturing Process Engineering vs Manufacturing Engineering?
| Aspect | Manufacturing Process Engineering | Manufacturing Engineering |
|---|---|---|
| Focus | Designing and optimizing manufacturing processes | Overseeing overall manufacturing systems and production |
| Responsibilities | Process development, process improvement, troubleshooting | Production planning, equipment selection, workflow management |
| Credentials | Engineering degree, process certifications | Engineering degree, manufacturing certifications |
| Work Environment | Process labs, manufacturing plants | Factories, production lines |
Manufacturing Process Engineering primarily focuses on developing and refining manufacturing processes to improve efficiency and quality. Manufacturing Engineering has a broader scope, overseeing entire production systems. Both roles require engineering backgrounds and often work closely within manufacturing industries.
What are the key skills and qualifications needed to thrive as a manufacturing process engineer?
What is manufacturing process engineering?

Full-time
Re-posted 14 days ago
Job description
Our mission is powered by our people. Our core values - be audacious, be curious, be authentic, be engaged, and be accountable - creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine's toughest problems, we encourage you to read the opportunity below and apply.
The Opportunity
The Process Engineer, Drug Product, will provide technical and GMP support for contract manufacturing organizations (CMOs) responsible for late-stage clinical and commercial drug product supply. This role serves as the primary technical subject matter expert (SME) for aseptic processing including sterile filtration, formulation, filling, and container closure systems. The role will establish and maintain strong, trust-based relationships with CMO technical and quality teams to ensure reliable, compliant, and efficient manufacturing of aseptically filled drug products. Operating as a highly agile technical expert, partnering with CMOs and internal stakeholders to ensure robust execution across technology transfer, validation, and lifecycle management. This role reports to the Associate Director, CMC Drug Product.
Responsibilities
Commercial & Clinical Aseptic Manufacturing Support:
- Support technical leadership and day-to-day aseptic process engineering support for clinical and commercial drug product manufacturing at external CMOs.
- Serve as the aseptic processing SME during manufacturing operations providing onsite support when required.
- Lead investigations, perform rigorous root cause analysis and develop scientifically sound CAPAs, ensuring alignment with regulatory expectations and industry best practices.
- Assess and author technical risk assessments and change controls to support manufacturing changes, investigations, and regulatory filings.
- Ensure strict compliance with cGMPs, global regulatory requirements, and internal quality systems for aseptic manufacturing.
Process Validation & Product Launch
- Lead and support aseptic drug product technology transfer activities from development to clinical and commercial manufacturing sites.
- Define and transfer critical process parameters (CPPs), critical quality attributes (CQAs), and in-process controls for aseptic unit operations.
- Develop and execute aseptic process validation strategies, including PPQ planning, statistical sampling plans, and acceptance criteria aligned with regulatory guidance.
- Provide technical authorship and review for regulatory submissions (IND, BLA, NDA, MAA), validation reports, and responses to regulatory agency questions.
- Support new product introductions and commercial launches by ensuring validated, scalable, and inspection-ready aseptic processes.
Data Analysis & Continued Process Verification
- Lead continued process verification (CPV) and routine data trending for aseptic unit operations, environmental monitoring, and critical process parameters.
- Develop and maintain data repositories, dashboards, and meaningful KPIs to assess aseptic process capability and performance.
- Identify early signals of process drift or increased contamination risk and proactively drive corrective or preventive actions.
- Prepare and present quarterly CPV summaries and technical assessments for internal management reviews.
Continuous Improvement
- Identify and execute continuous improvement initiatives focused on aseptic process robustness, sterility assurance, capacity, and operational efficiency.
- Apply Quality by Design (QbD), statistical tools, and risk-based decision making to optimize aseptic manufacturing processes.
- Collaborate with CMOs to implement best practices, new technologies, or process enhancements where appropriate
Required Qualifications
- Bachelor's degree in engineering or related field with 5+ years/ Master's with 3+ years of relevant experience.
- Prior experience in aseptic drug product manufacturing for late-stage development/commercial is required. Device experience is a plus.
- Proficiency in Quality by Design (QbD), Design of Experiments (DoE), statistical process control (SPC), and complex data analysis.
- Familiarity with modeling and optimization tools (e.g., MATLAB, JMP) is a plus.
- Detail-oriented with strong problem-solving skills and ability to identify subtle trends in data.
- Comprehensive understanding of cGMP principles and regulatory requirements, including process, equipment, and facility validation.
- Excellent communication and teamwork skills.
- Ability to travel to domestic and international CMOs as needed.
Work Location and Conditions
- At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii Michigan and Tennessee.
- You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested.
- You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.
#LI-TD1
#LI-Hybrid
Compensation
The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate's experience, skills, and qualifications, as well as considerations of internal equity.
Estimated Pay Range
$131,000-$147,000 USD
To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn.
To return to our website please click here.
Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx's management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
About Amylyx Pharmaceuticals
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
51 - 200 Employees
Headquarters location
Cambridge, MA, US
Year founded
2013