Cleaning Validation Engineer

Veranova; Harvard (MA); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Comprehensive health and wellness benefits

Competitive base salary

Tuition assistance for education

Job summary

A global leader in pharmaceutical manufacturing is seeking a Quality Assurance professional to serve as the site SME for cleaning validation. The candidate should have a minimum of 7 years of quality assurance experience and strong knowledge of regulatory guidelines. This role involves leading cleaning procedure development and ensuring compliance across manufacturing operations. Excellent analytical skills and a collaborative mindset are essential for success.

Qualifications

• Minimum 7 years of quality assurance experience.
• 3 years of experience in contamination control and cleaning validation.
• Strong knowledge of cGMP, FDA, EMA, and ICH guidelines.

Responsibilities

• Lead development and validation of cleaning procedures.
• Write and review cleaning validation protocols.
• Coordinate sampling and analytical testing.

Skills

Quality assurance experience

Contamination control

Cleaning validation

Environmental monitoring

Analytical skills

Technical writing

Education

Undergraduate degree in engineering, science or related field

Job description

Overview

Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. We are committed to building a talented and diverse workforce focused on quality, compliance, safety, and excellence in delivery. We seek innovative individuals with a growth mindset who want to make a difference.

Role: This role serves as the site SME for all cleaning validation and verification activities related to intermediate and API manufacturing, including facility surfaces and equipment. You’ll work with cross-functional teams to ensure regulatory compliance and implement effective cleaning strategies that meet customer expectations. This position maintains high quality and safety standards across manufacturing operations and manages the environmental and purified water monitoring programs to ensure consistent product quality.

Core 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 residues or contaminants are removed.
• Coordinate and conduct sampling (swab, rinse, surface) and analytical testing to validate cleaning processes and confirm effectiveness.
• Develop and maintain cleaning validation schedules to ensure timely completion of validations.
• Review cleaning validation data, ensure it meets acceptance criteria, and recommend process improvements.

Qualifications

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.
• Experience working in cross-functional and project-based environments; ability to drive continuous improvement with metrics.
• Excellent analytical, written and verbal communication and presentation skills; promotes a positive work culture.
• Hands-on experience with cleaning validation, TOC analysis, and bioburden reduction strategies.
• Strong understanding of cGMP regulations; ability to execute validation independently; capable of managing complex projects.
• Experience working effectively as part of a team and as an individual contributor; aligns with Veranova culture for inclusivity and business results.
• Hands-on experience with sterile and cleaning validation processes; strong technical writing skills.
• Experience in a fast-paced work environment.

Preferred

• Certification in contamination control (e.g., PDA Certification in Contamination Control).
• Knowledge of risk-based approaches to cleaning validation (e.g., Risk Assessment and ICH Q9).
• Experience with Lean or Six Sigma methodologies.
• Familiarity with environmental monitoring equipment and purified water system design and validation.

Our Commitment

• Health & Wellness: Comprehensive health & wellness benefits, mental health resources, generous PTO and holiday pay policies.
• Financial Wellness: Competitive base salary, Defined Contribution Pension, performance-based bonuses, and 401(k) with company match.
• Professional Development: Learning opportunities through LinkedIn Learning, workshops, conferences, and mentorship; tuition assistance for undergraduate and graduate programs.
• Inclusive Culture: Veranova values an inclusive environment where everyone can bring their full self to work and thrive.

How to Apply

Visit www.veranova.com to view open roles and join our Talent Community to stay connected and learn about opportunities. We encourage applicants who may not meet every qualification to apply if they believe they can contribute to improving and saving patients’ lives. Veterans, first responders, and transitioning service members are encouraged to apply. For accommodations due to disability, email [e-mail] with the job number, title, and location.

Additional Information

• Applicants must be authorized to work in the United States without employer sponsorship.
• Veranova does not accept unsolicited resumes from agencies or search firms.
• Important Notice Regarding Recruitment Scams: See our security notice for authentic communications and scams.
• All your information will be kept confidential according to EEO guidelines. Veranova is an Equal Opportunity Employer and commits to equal employment opportunity regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity, disability, or veteran status.
• All applications are stored securely in Veranova’s Application Management System; privacy notice applies.

Job Function and Industry

• Job function: Quality Assurance
• Industries: Pharmaceutical Manufacturing