Contamination Control Specialist

Job Description

Who We Are:

At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented and diverse workforce in our industry. Our commitment to uncompromising focus on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference.

Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation.

Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients.

Role Overview:

This Contamination Control Specialist is the site SME responsible for coordinating all cleaning validation and verification activities related to intermediate and API manufacturing, including facility surfaces and equipment. This role involves close collaboration with various departments to ensure compliance with regulatory and customer requirements while implementing effective cleaning strategies across the site. The position is integral to maintaining quality and safety standards in the manufacturing process, supporting both current operations and customer needs. The role is also responsible for managing the environmental and purified water monitoring programs to ensure product quality and safety throughout the manufacturing process.

Core Responsibilities:

Contamination Control

Develop, implement, and maintain contamination control strategies and programs to ensure the protection of product quality in manufacturing environments.

Monitor and evaluate the effectiveness of existing contamination control systems (including air handling systems, HVAC, and microbiological controls).

Perform routine environmental monitoring in across manufacturing facilities to assess microbial and particulate contamination.

Assess, review, and improve cleaning, environmental and contamination control procedures to meet GMP, regulatory, and internal standards, including conducting risk assessments and implementation of risk mitigation strategies.

Establish contamination control metrics and key performance indicators (KPIs) to track and report progress against site goals.

Cleaning Validation:

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.

Environmental Monitoring & Purified Water Monitoring:

Oversee and manage the environmental monitoring program, ensuring compliance with established guidelines for monitoring particulate, microbial, and endotoxin levels in manufacturing and critical areas.

Review and interpret environmental monitoring data and identify trends or excursions, initiating corrective actions or investigations as needed.

Develop and implement strategies to prevent contamination and maintain a suitable environment in manufacturing and processing areas.

Oversee the purified water (PW) monitoring program, ensuring compliance with quality standards for water used in pharmaceutical intermediate and API manufacturing.

Conduct routine sampling, testing, and analysis of purified water systems to ensure that water meets pharmacopeial standards (e.g., USP or EP) for microbial quality, endotoxin levels, and other relevant parameters.

Investigate and troubleshoot any deviations or issues with purified water quality, implementing corrective actions and ensuring the integrity of water systems.

Compliance & Documentation:

Ensure all contamination control, cleaning validation, environmental monitoring, and purified water monitoring activities are fully compliant with applicable cGMP guidelines, FDA, EMA, ICH, and other regulatory requirements.

Review and approve standard operating procedures related to cleaning, environmental monitoring, and water systems to ensure they meet regulatory standards.

Prepare and maintain detailed documentation of cleaning validation protocols, deviations, change controls, EM and PW monitoring results, and corrective and preventive actions.

Provide support during regulatory inspections and audits, addressing any findings or questions related to contamination control, cleaning validation, or monitoring programs.

Qualifications:

Required

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

Minimum 5 years of quality assurance experience with a graduate degree in engineering, science or related field or

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

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

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

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 continuous improvement methodologies such as Lean or Six Sigma desire

Familiarity with environmental monitoring equipment and purified water system design and validation

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

Our Commitment:

Health & Wellness: Comprehensive health & Wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies.

Financial Wellness: Comprehensive total compensation package that includes competitive base salary, Defined Contribution Pension program, eligibility for performance-based bonuses, and attractive 401(k) Plan with company match.

Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs.

Inclusive Culture: At Veranova an inclusive culture is integral to our values. We are committed to ensuring that everyone can bring their full self to work and thrive in their career.

How to Apply:

At Veranova, we are on a mission to meet people that believe in our values and can contribute to the team in a variety of ways. Please visit to view all open roles and join our Talent Community to stay connected and learn about opportunities as they arise.

We value a range of experiences and perspectives. If you want to be part of improving and saving the lives of patients, we encourage you to apply regardless of whether you meet every qualification listed.

If you are a veteran, first responder, or in the process of transitioning from service member to civilian life, we encourage you to apply. Your experience brings invaluable skills and insights that can contribute to our team.

For applicants who may require a reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email to in order to confirm your request for an accommodation. Please include the job number, title, and location of role. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Veranova employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Additional Information:

Applicants for this role must be authorized to work in the United States without further employer sponsorship.

Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting.

Important Notice Regarding Recruitment Scams: Veranova is committed to providing a professional and secure recruitment experience for all applicants. Unfortunately, fraudulent job postings and recruitment scams are becoming more prevalent. We want to ensure that all candidates are aware of potential scams. Please see our notice here.

Legitimate communications from Veranova will only come from official email addresses using our domain: @veranova.com.

Legitimate LinkedIn communications will only come from active Veranova employees.

Veranova will never ask candidates for sensitive personal information during the application process (e.g., bank account details or social security number).

Veranova will never ask candidates for payment (e.g., for equipment, training, or background checks).

If you have any doubts or concerns about the authenticity of a job posting, please reach out to our HR department: (US) or (UK).

All your information will be kept confidential according to EEO guidelines.

Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.

All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.

Full-time