Validation Engineer
Validation Engineer
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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 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 nextgeneration therapeutics to improve and save the lives of patients.
Role Overview:
The Validation Engineer will lead the validation program at our site ensuring that all equipment processes and systems meet regulatory and quality standards. This role involves maintaining the Site Validation Standard Operating Procedures (SOP) developing validation protocols for new and existing equipment and executing these protocols to verify compliance and performance.
Core Responsibilities:
- Validation Program Management: Oversee the entire validation lifecycle from planning to documentation and review.
- SOP Maintenance: Regularly update and maintain the validation SOPs to reflect best practices regulatory changes and operational needs.
- Protocol Development: Design and write validation protocols for new equipment installations ensuring they meet both internal standards and regulatory requirements.
- Protocol : Perform or coordinate the of validation protocols including Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ). This includes coordination with 3rd parties and contactors for SATs.
- Documentation: Ensure all validation activities are thoroughly documented with accurate compliant and auditable records.
- Compliance: Monitor and ensure adherence to all relevant regulations (e.g. FDA GMP ISO) and company quality standards.
- Training: Provide training to staff on validation processes and compliance.
- Customer Focus: Participate in customer audits to be the SME for equipment validation on site.
Qualifications:
- Bachelors Degree in Engineering Life Sciences or a related field.
- At least 5 years of experience in validation within a regulated industry (e.g. pharmaceuticals biotech medical devices).
- Demonstrated experience in developing writing and executing validation protocols.
- Familiarity with current Good Manufacturing Practices (cGMP) FDA guidelines and ISO standards.
- Including but not limited to 21 CFR 11 CFR 21 Part 820 ICH Q7 ICH Q9 and ICH Q10.
- Proficient in validation methodologies and documentation.
- Ability to analyze complex systems and processes to ensure they meet validation criteria.
- DetailOriented: Keen attention to detail in developing protocols executing tests and documenting results.
- Capable of addressing and resolving validation issues efficiently.
- Proven leadership qualities to manage validation projects and coordinate across departments.
- Excellent organizational capabilities to manage multiple validation projects concurrently.
- Strong verbal and written communication skills for interacting with various teams and documenting complex processes.
- Ability to adapt to changing regulations technologies or business needs.
- Collaborative mindset to work effectively with crossfunctional teams including Quality Assurance Engineering and Production.
- Skills in planning executing and overseeing validation projects to meet deadlines and quality standards.
- Proficient in creating clear concise and technically accurate documentation
Preferred
- Experience with API manufacturing
- Knowledge of validation software/tools
- DeltaV knowledge
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 performancebased 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 www.veranova 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.
- 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.
Employment Type
Full-Time
