ZipRecruiter

Log In

1

Statistical Process Control Engineer Jobs in Boston, MA

Vrtx

CMC Statistics Director

Boston, MA · On-site

... Statistical Process Control (SPC), and process capability monitoring * Support analytical method ... D. in Statistics, Biostatistics, Industrial Engineering, Applied Mathematics, Data Science, or ...

Actalent

Process Engineer

Beverly, MA

$90K - $145K/yr

Process Engineer We are seeking a Process Engineer to oversee the end-to-end process qualification ... Statistical Process Control, Measurement System Analysis, failure analysis, and root cause analysis.

Automationtechies

Control Engineer

Boston, MA · On-site

$90K - $117K/yr

You will support controls engineering project requirements involving PLC programming, DCS ... Working knowledge of field instruments and instrumentation used in process control systems

Automationtechies

Control Engineer

Boston, MA · On-site

$90K - $117K/yr

Engineers in this position collaborate closely with clients, manage multiple projects, and ... Experience with PLCs, motion control, process control, robotics, machine vision, and SCADA systems

Automationtechies

Control Engineer

Boston, MA · On-site

$90K - $117K/yr

You will support controls engineering project requirements involving PLC programming, DCS ... Working knowledge of field instruments and instrumentation used in process control systems

Automationtechies

Control Engineer

Boston, MA · On-site

$90K - $117K/yr

Engineers in this position collaborate closely with clients, manage multiple projects, and ... Experience with PLCs, motion control, process control, robotics, machine vision, and SCADA systems

previous pagenext page

Showing results 21-40

All JobsStatistical Process Control Engineer JobsStatistical Process Control Engineer Jobs in Boston, MA

Statistical Process Control Engineer information

See Boston, MA salary details

$57K

$107.3K

$159.7K

How much do statistical process control engineer jobs pay per year?

As of Sep 5, 2026, the average yearly pay for statistical process control engineer in Boston, MA is $107,291.00, according to ZipRecruiter salary data. Most workers in this role earn between $82,000.00 and $126,600.00 per year, depending on experience, location, and employer.

What does a Statistical Process Control Engineer do?

A Statistical Process Control (SPC) Engineer is responsible for designing, implementing, and maintaining systems that monitor and control manufacturing processes using statistical methods. They analyze data to identify trends, reduce process variation, and improve product quality. SPC Engineers work closely with production teams to ensure processes remain stable, efficient, and in compliance with industry standards. Their role often involves training staff in SPC techniques and troubleshooting quality issues using data-driven approaches.

What are the key skills and qualifications needed to thrive as a Statistical Process Control Engineer?

To thrive as a Statistical Process Control Engineer, you need a solid background in statistics, process engineering, and quality management, often supported by a degree in engineering or a related field. Familiarity with SPC software (such as Minitab or JMP), Six Sigma methodologies, and quality system certifications like ASQ are typically required. Strong analytical thinking, attention to detail, and effective communication are crucial soft skills for interpreting data and collaborating with cross-functional teams. These skills and qualifications are vital to maintain product quality, optimize processes, and drive continuous improvement within manufacturing or production environments.

How does a Statistical Process Control Engineer typically collaborate with production and quality teams to drive process improvements?

A Statistical Process Control Engineer regularly works alongside both production and quality assurance teams to identify trends, troubleshoot issues, and implement data-driven improvements. They analyze real-time data from manufacturing processes, facilitate root cause analysis sessions, and communicate findings through reports or presentations. Collaboration often includes training team members on SPC tools and methodologies, as well as guiding them in using statistical techniques to monitor and control process variability. This cross-functional teamwork ensures that process adjustments are both technically sound and operationally practical, leading to sustained quality improvements.

What is the difference between Statistical Process Control Engineer vs Quality Engineer?

AspectStatistical Process Control EngineerQuality Engineer
Primary FocusMonitoring and controlling manufacturing processes using statistical methodsEnsuring overall product quality through testing, inspection, and process improvements
CertificationsSix Sigma, Statistical Process Control (SPC) certificationsSix Sigma, Quality Management certifications (e.g., CQE)
Work EnvironmentManufacturing plants, process development labsQuality departments, production facilities
Industry UsageManufacturing, automotive, electronicsManufacturing, healthcare, aerospace

While both roles focus on improving product quality, the Statistical Process Control Engineer specializes in using statistical tools to monitor and control manufacturing processes, whereas the Quality Engineer oversees broader quality assurance activities, including testing and compliance. Understanding these differences helps in choosing the right career path or job search focus.

What is statistical process control in engineering?

Statistical Process Control (SPC) is a method used by engineers, including those in quality and manufacturing roles, to monitor and control a process through statistical analysis. It involves collecting data from production processes, using control charts to detect variations, and ensuring consistent product quality by identifying and addressing issues early. SPC tools like Pareto charts and process capability analysis are commonly employed to maintain process stability and improve efficiency.

What are popular job titles related to Statistical Process Control Engineer jobs in Boston, MA?

For Statistical Process Control Engineer jobs in Boston, MA, the most frequently searched job titles are:

What job categories do people searching Statistical Process Control Engineer jobs in Boston, MA look for?

The top searched job categories for Statistical Process Control Engineer jobs in Boston, MA are:

Statistical Process Control Engineer jobs near you
Infographic showing various Statistical Process Control Engineer job openings in Boston, MA as of June 2026, with employment types broken down into 54% Full Time, 36% Part Time, 8% Contract, and 2% Nights. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $107,291 per year, or $51.6 per hour.

CMC Statistics Director

Vertex Pharmaceuticals

Boston, MA • On-site

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 13 days ago

Vertex Pharmaceuticals rating

6.5

Company rating: 6.5 out of 10

Based on 5 frontline employees who took The Breakroom Quiz

78th of 86 rated pharmaceutical

Job description

Job Description
General Summary:
The CMC Statistics Director (Scientific Fellow) provides strategic and technical leadership for the application of statistical sciences across the product lifecycle, including process development, analytical development, manufacturing, process validation, continued process verification (CPV), stability, quality control, and regulatory submissions. This individual will establish and lead the CMC Statistics capability, enabling data-driven decision-making to enhance product quality, process robustness, operational efficiency, and regulatory compliance. The role partners closely with Development, MSAT, Quality, Regulatory Affairs, and Data & Digital teams to ensure the effective application of advanced statistical methodologies across all CMC functions. The position will drive the adoption of best practices in statistical analysis, DOE, process monitoring, and manufacturing data analytics to support Vertex's growing portfolio and evolving manufacturing network.
This individual will demonstrate Vertex Core Values while fostering a culture of scientific excellence, continuous improvement, innovation, collaboration, and quality.
Key Duties and Responsibilities:
  • Partner with Development, Manufacturing, Quality, Regulatory Affairs, and Data & Digital organizations to provide strategic statistical leadership across the CMC lifecycle
  • Establish and lead the CMC Statistics Center of Excellence, defining standards, governance, methodologies, and best practices for statistical analyses
  • Provide statistical leadership for process characterization, process optimization, process robustness studies, technology transfer activities, and lifecycle management programs
  • Support the application of Design of Experiments (DOE) methodologies to support product and process development, optimization, and control strategy development
  • Develop and implement statistical approaches supporting Process Performance Qualification (PPQ), Continued Process Verification (CPV), Statistical Process Control (SPC), and process capability monitoring
  • Support analytical method development, qualification, validation, and lifecycle management through statistically sound study design and data analysis
  • Provide advanced statistical support for stability programs, shelf-life estimation, comparability assessments, and global regulatory submissions
  • Serve as the subject matter expert for exploratory data analysis, outlier assessments, regression modeling, multivariate analysis, and predictive modeling techniques
  • Support investigations, deviations, CAPAs, quality risk assessments, and manufacturing troubleshooting activities through quantitative data analysis
  • Drive adoption of advanced analytics, digital solutions, machine learning, and AI-enabled statistical approaches across Technical Operations and Quality
  • Author, review, and defend statistical content for regulatory submissions and health authority interactions
  • Develop and deliver statistical training programs that increase statistical literacy and data-driven decision-making throughout the organization
  • Continuously evaluate emerging industry trends, technologies, and best practices in CMC statistics and pharmaceutical manufacturing analytics

Knowledge and Skills:
  • Recognized expertise in statistical methodologies supporting pharmaceutical development, manufacturing, quality, and regulatory submissions
  • Extensive knowledge of Design of Experiments (DOE), multivariate analysis, regression modeling, process capability analysis, statistical process control, and process validation methodologies
  • Strong understanding of Continued Process Verification (CPV), Process Performance Qualification (PPQ), commercial manufacturing monitoring, and lifecycle process verification
  • Deep understanding of analytical method validation, stability analysis, shelf-life estimation, and comparability assessments
  • Proficiency with statistical software platforms including JMP, Minitab, SAS, R, Python, and other advanced analytics tools
  • Strong understanding of FDA, EMA, ICH, and global regulatory expectations related to CMC statistical analyses and process validation
  • Knowledge of data integrity principles, including ALCOA+ requirements, and their application in regulated environments
  • Strong leadership, influencing, stakeholder management, and change management capabilities
  • Exceptional written, verbal, and presentation skills with the ability to communicate effectively across technical and executive audiences

Education and Experience:
  • Ph.D. in Statistics, Biostatistics, Industrial Engineering, Applied Mathematics, Data Science, or related quantitative discipline with 10+ years of relevant industry experience; or
  • M.S. in Statistics, Biostatistics, Industrial Engineering, Applied Mathematics, Data Science, or related quantitative discipline with 12+ years of relevant industry experience
  • Demonstrated experience supporting CMC development, process validation, manufacturing, quality operations, and regulatory submissions in a pharmaceutical or biotechnology environment
  • Experience applying statistical methodologies across biologics, cell and gene therapy, small molecules, and/or combination products preferred
  • Demonstrated success establishing statistical best practices, governance models, and capability-building programs within regulated environments
  • Experience leveraging advanced analytics, machine learning, digital manufacturing, and AI-enabled solutions preferred
  • Experience supporting global regulatory inspections, responses, and health authority interactions is strongly preferred

Pay Range:
$193,100 - $289,700
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
#LI-Hybrid
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex 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, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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 make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

What Vertex Pharmaceuticals employees say

Hours and flexibility

Workplace

Get the full story on Breakroom

Apply