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Cleaning Validation Engineer Jobs in Boston, MA (NOW HIRING)

Sebela Pharma

CQV/Validation Engineer

Holbrook, MA · On-site

$33 - $43/hr

The CQV/Validation Engineer is responsible for supporting the activities required to implement the ... Support equipment, utility, facility, process, cleaning, and computerized system validation ...

Syner-G

Validation Engineer

Boston, MA · On-site +1

The Validation Engineer will be responsible for driving overall quality performance and compliance ... Generate and execute life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping ...

Syner-G

Validation Engineer

Boston, MA · On-site

The Validation Engineer will be responsible for driving overall quality performance and compliance ... Generate and execute life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping ...

Syner-G

Validation Engineer

Boston, MA · On-site

The Validation Engineer will be responsible for driving overall quality performance and compliance ... Generate and execute life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping ...

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Cleaning Validation Engineer information

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How much do cleaning validation engineer jobs pay per hour?

As of Aug 27, 2026, the average hourly pay for cleaning validation engineer in Boston, MA is $56.65, according to ZipRecruiter salary data. Most workers in this role earn between $42.93 and $68.89 per hour, depending on experience, location, and employer.

What is a cleaning validation engineer?

A Cleaning Validation Engineer ensures that manufacturing equipment and processes meet regulatory standards for cleanliness in industries like pharmaceuticals, biotech, and medical devices. They develop validation protocols, conduct tests, analyze data, and document results to confirm that cleaning procedures effectively remove contaminants. This role involves collaborating with quality assurance, production, and regulatory teams to maintain compliance with FDA, GMP, and other industry regulations.

What are the main challenges faced by cleaning validation engineers in the pharmaceutical industry?

Cleaning Validation Engineers in the pharmaceutical industry often face challenges such as staying up-to-date with evolving regulatory requirements, troubleshooting complex cleaning failures, and thoroughly documenting all validation activities. Balancing the needs for robust contamination control with operational efficiency requires analytical thinking and strong problem-solving abilities. Collaboration with manufacturing, quality assurance, and laboratory teams is frequent, as cleaning validation projects require input and support from multiple departments. Successfully managing these challenges ensures product safety, regulatory compliance, and continuous process improvement within manufacturing operations.

What are the key skills and qualifications needed to thrive as a cleaning validation engineer, and why are they important?

To thrive as a Cleaning Validation Engineer, you need a strong background in chemical engineering, microbiology, or a related field, often complemented by experience in GMP-regulated industries. Familiarity with validation protocols, analytical testing methods, and documentation tools (such as LIMS or QMS software) is essential, and certifications like Six Sigma or ASQ may be advantageous. Strong attention to detail, analytical thinking, and effective communication are key soft skills for success in the role. These capabilities are crucial to ensure regulatory compliance, product safety, and effective cross-functional collaboration in pharmaceutical or biotech manufacturing environments.

What are the most commonly searched types of Cleaning Validation Engineer jobs in Boston, MA?

The most popular types of Cleaning Validation Engineer jobs in Boston, MA are:

What are popular job titles related to Cleaning Validation Engineer jobs in Boston, MA?

For Cleaning Validation Engineer jobs in Boston, MA, the most frequently searched job titles are:

What job categories do people searching Cleaning Validation Engineer jobs in Boston, MA look for?

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Cleaning Validation Engineer jobs near you
Infographic showing various Cleaning Validation Engineer job openings in Boston, MA as of August 2026, with employment types broken down into 1% As Needed, 66% Full Time, 28% Part Time, 1% Temporary, 3% Contract, and 1% Nights. Highlights an 97% Physical, 1% Hybrid, and 2% Remote job distribution, with an average salary of $117,497 per year, or $56.5 per hour.

CQV/Validation Engineer

Holbrook, MA • On-site

Sebela Pharma
See more jobs at Sebela Pharmaexternal

$33 - $43/hr

Full-time

Re-posted 21 days ago

Job description

Sebela Pharmaceuticals is a U.S. pharmaceutical company with a market-leading position in Gastroenterology and a focus on innovation in Women's Health. Our Vision is to build the leading Gastroenterology company in the U.S., with a complementary focus on innovation in Women's Health, premised on our expertise in pharmaceutical development and commercialization. Braintree Laboratories, Inc., a part of Sebela Pharmaceuticals, has its contract development and manufacturing organization (CDMO) in Holbrook, MA, offering pharmaceutical-development and in-house manufacturing services for specialty gastroenterology products.
We value dedication, energy, and enthusiasm, and we focus on innovation and results while striving to achieve our corporate mission and vision. Sebela Pharmaceuticals is committed to cultivating an inclusive environment where all employees are treated with respect. We accomplish this by fostering a culture of diversity, equity and inclusion, which is essential to innovation and continuous improvement. Sebela operates from three locations in Roswell, Georgia, Braintree and Holbrook, MA and headquarters in Dublin, Ireland.
The CQV/Validation Engineer is responsible for supporting the activities required to implement the Holbrook site's validation plan in compliance with current industry and regulatory expectations. This role supports the development, review, execution, and completion of qualification, validation, and related cGMP documentation.
PRINCIPAL DUTIES AND RESPONSIBILITIES
  • Participate in validation, qualification, and commissioning activities for pharmaceutical manufacturing equipment, utilities, facilities, processes, cleaning programs, and computerized systems.
  • Participate in validation and CQV projects from planning through documentation, execution, discrepancy resolution, approval, and closeout.
  • Develop, review, and/or execute validation documentation such as change control, test scripts, protocols, reports, User Requirements Specifications, risk assessments, traceability matrices, and related supporting documents.
  • Support equipment, utility, facility, process, cleaning, and computerized system validation activities, as assigned.
  • Document and assist in resolving protocol discrepancies, deviations, incidents, nonconformances, and validation issues, including impact assessments and corrective actions/CAPA.
  • Collaborate with Manufacturing, Engineering, Quality Assurance, Quality Control, Technical Operations, IT, and external vendors to support validation deliverables and project timelines.
  • Review and revise GMP documentation, including SOPs, batch records, protocols, reports, forms, and related controlled documents.
  • Complete GMP documentation and validation records accurately, clearly, and contemporaneously in accordance with company procedures and good documentation practices.

QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential function satisfactorily, be flexible in terms of work hours, and have knowledge and experience in Equipment and Utility Qualification, Process Validation, Cleaning Validation and/or Computerized System Validation. The requirements listed below are representative of the knowledge, skills and/or abilities required. Equivalent combination of education and relevant experience will be considered.
  • Bachelor's degree or higher in Engineering, Life Sciences or related discipline.
  • 3+ years relevant FDA regulated industry/validation experience or an equivalent amount of validation experience.
  • Experience with validation, qualification, commissioning, CQV, manufacturing support, quality systems, engineering documentation, or technical project execution.
  • Familiarity with one or more of the following areas is preferred: equipment qualification, facility qualification, utility qualification, cleaning validation, process validation, computerized system validation, or commissioning.
  • Ability to write, review, or execute technical documents such as protocols, test scripts, reports, SOPs, batch records, specifications, risk assessments, or deviation investigations.
  • Strong problem-solving, communication, and technical writing skills.
  • Knowledge of good documentation practices and cGMPs required.
  • Knowledge of 21 CFR Part 11, validation lifecycle principles, or risk-based validation approaches preferred.
  • Auto CAD experience preferred.
  • Flexible to work overtime (paid) as needed.

Pay Range: $33.00 - $43.00 per hour/annualized at $68-89K not including any overtime pay (this reflects our reasonable and good faith estimate of what will be paid at the time of posting). Competitive benefits package included.

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