Cleaning Validation Engineer

Job Description

Job Description

About Company:

Who Are We?

ELIQUENT Life Sciences is a leading global consulting group delivering regulatory affairs, pharmacovigilance, quality, and compliance solutions that support pharmaceutical, biotechnology, medical device, and combination product companies across therapeutic modalities, phase-based pathways, and major global markets.

Why explore your future at ELIQUENT?

ELIQUENT Life Sciences is a trusted global consulting firm helping life sciences companies navigate regulatory complexity and bring breakthrough therapies to market. Founded by former regulators and industry experts, we offer end-to-end support in regulatory affairs, pharmacovigilance, and quality compliance. Our team is driven by a shared mission to improve global health through innovation, collaboration, and integrity. At ELIQUENT, you will be part of a purpose-led organization where your expertise contributes to meaningful impact and your growth is supported every step of the way.

About the Role:

The Cleaning Validation Engineer plays a critical role in ensuring that pharmaceutical manufacturing equipment and processes meet stringent cleanliness standards to guarantee product safety and regulatory compliance. This position is responsible for designing, executing, and maintaining cleaning validation protocols that confirm the effective removal of contaminants and residues from manufacturing systems. The engineer collaborates closely with cross-functional teams including quality assurance, production, and engineering to develop scientifically sound validation strategies aligned with industry best practices and regulatory requirements. By analyzing data and continuously improving cleaning processes, the role helps to minimize risks of cross-contamination and supports the overall integrity of pharmaceutical products. Ultimately, the Cleaning Validation Engineer ensures that all cleaning activities are validated, documented, and compliant with FDA, EMA, and other relevant regulatory bodies, thereby safeguarding patient health and company reputation.

Minimum Qualifications:

• Bachelor’s degree in Pharmaceutical Engineering, Chemical Engineering, or a related scientific discipline.
• Demonstrated experience in cleaning validation within pharmaceutical manufacturing environments.
• Strong knowledge of Sterilize-In-Place (SIP) systems and pharmaceutical manufacturing processes.
• Familiarity with regulatory requirements such as FDA, EMA, and ICH guidelines related to cleaning validation.
• Proficiency in developing and executing validation protocols and technical reports.

Preferred Qualifications:

• Advanced degree (Master’s or higher) in Pharmaceutical Engineering or related field.
• Experience with automation and control systems used in pharmaceutical manufacturing.
• Certification in validation or quality assurance (e.g., ASQ Certified Quality Engineer).
• Hands-on experience with analytical techniques such as HPLC, TOC, or ATP bioluminescence for cleaning verification.
• Strong project management skills and experience leading cross-functional validation projects.

Responsibilities:

• Develop, review, and execute cleaning validation protocols and reports in accordance with cGMP and regulatory guidelines.
• Perform risk assessments and establish acceptance criteria for cleaning processes based on product and equipment characteristics.
• Collaborate with manufacturing and quality teams to identify critical cleaning parameters and optimize cleaning procedures.
• Conduct sampling, analytical testing, and data analysis to verify the effectiveness of cleaning processes.
• Maintain comprehensive documentation and ensure all validation activities are audit-ready and compliant with regulatory standards.
• Investigate and resolve deviations or non-conformances related to cleaning validation activities.
• Stay current with industry trends, regulatory changes, and emerging technologies to continuously improve cleaning validation practices.

Skills:

The required skills such as expertise in SIP systems and pharmaceutical manufacturing processes are applied daily to design and optimize cleaning validation protocols that ensure equipment cleanliness and product safety. Pharmaceutical engineering knowledge enables the engineer to understand complex manufacturing systems and develop scientifically robust validation strategies. Analytical skills are essential for interpreting test results and making data-driven decisions to improve cleaning procedures. Preferred skills like familiarity with advanced analytical techniques and automation systems enhance the engineer’s ability to implement innovative solutions and increase validation efficiency. Effective communication and project management skills facilitate collaboration with multidisciplinary teams and ensure timely completion of validation projects in compliance with regulatory standards.