Quality Assurance - Cleaning Validation Specialist
Quality Assurance - Cleaning Validation Specialist
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1 Vacancy
Job Description
Who We Are:
At Veranova we believe people are our most important asset and we are dedicated to building the most talented 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:
The Cleaning Validation 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:
- 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.
Qualifications:
- 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
- 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
- A mindset that promotes a positive work culture
- 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
- 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
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 misson to meet people that believe in our values and can contribute to the team in a variety of ways. Please visitto view all open roles and join ourTalent Communityto 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.
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 noticehere.
- Legitimate communications from Veranova will only come from official email addresses using our domain: @.
- 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 TA department: Veranova Talent Acquisition
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 ourprivacy notice.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
