Apply on Employer Site

Veranova · 1 day ago

Cleaning Validation Engineer

Devens, MA

Full-time

Onsite

Senior Level

$90K/yr - $100K/yr

7+ years exp

Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients for pharma and biotech customers. The Cleaning Validation Engineer will serve as the site SME for cleaning validation activities, ensuring compliance and implementing effective cleaning strategies to maintain high quality and safety standards across manufacturing operations.

BiotechnologyHealth CareManufacturingPharmaceutical

No H1B

Hiring Manager

Shelley Talarico

Responsibilities

Lead the development, execution, and validation of cleaning procedures for equipment, production lines, and facilities

Write and review cleaning validation protocols and reports in compliance with regulatory requirements, ensuring that all materials are free of any residues or contaminants

Coordinate and conduct sampling (e.g., swab, rinse, and surface) and analytical testing to validate cleaning processes and confirm cleaning effectiveness

Develop and maintain cleaning validation schedules to ensure timely completion of required validations

Review cleaning validation data, ensuring it meets established acceptance criteria, and make recommendations for process improvements

Qualification

Cleaning validationContamination controlEnvironmental monitoringCGMP regulationsAnalytical testingRisk assessment toolsTechnical writingContinuous improvementLeadership experienceTeam collaboration

Required

Minimum 7 years of quality assurance experience with an undergraduate degree in engineering, science or related field

Minimum of 3 years of experience in contamination control, cleaning validation, environmental monitoring, and/or purified water systems, preferably in a pharmaceutical or biotech manufacturing environment (API CDMO experience is highly desirable)

Proven leadership experience in pharmaceutical, API/intermediate, medical device, biologics or related FDA industry

Strong knowledge of cGMP, FDA, EMA, ICH guidelines, and other regulatory standards related to contamination control, cleaning validation, environmental monitoring, and purified water systems

Experience with microbiological sampling, environmental monitoring, and testing of purified water systems in a regulated pharmaceutical environment

Proficiency with risk assessment tools such as FMEA

Previous experience working in cross-functional and project-based environments

Experience creating metrics for driving continuous improvement

Excellent analytical, written and verbal communication and presentation skills and a mindset that promotes a positive work culture

Hands-on experience with cleaning validation, TOC analysis, and bioburden reduction strategies

Driven and detail-oriented, with a strong understanding of cGMP regulations and previous experience in cleaning validation

Experience driving complex projects with the ability to initiate, prioritize, and successfully complete tasks

Proven experience working effectively in team situations and as an individual contributor

Demonstrated behaviours that model the Veranova culture to achieve an inclusive environment and exceptional business results

The ideal candidate will have hands-on experience with sterile and cleaning validation processes, strong technical writing skills, and the ability to execute validation protocols independently

Experience in a fast-paced work environment