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 Process Validation Engineer plays a critical role in ensuring that manufacturing processes consistently produce products that meet predetermined quality standards and regulatory requirements. This position involves designing, executing, and documenting validation protocols to confirm that processes operate within defined parameters and yield reliable, reproducible results. The engineer collaborates closely with cross-functional teams including manufacturing, quality assurance, and regulatory affairs to identify process risks and implement corrective actions. By analyzing process data and trends, the engineer supports continuous improvement initiatives that enhance process efficiency and product quality. Ultimately, this role ensures compliance with industry standards and contributes to the successful commercialization of products within the United States market.

Minimum Qualifications:

• Bachelor’s degree in Engineering, Science, or a related technical field.
• 3+ years of experience in process validation within a regulated manufacturing environment.
• Strong knowledge of validation principles, methodologies, and regulatory requirements (e.g., FDA, cGMP, ISO).
• Experience with statistical analysis and process capability studies.
• Excellent written and verbal communication skills.

Preferred Qualifications:

• Master’s degree in Engineering, Quality Assurance, or related discipline.
• Experience in the pharmaceutical, biotechnology, or medical device industries.
• Familiarity with automation systems and computerized system validation (CSV).
• Certification in Quality or Validation (e.g., ASQ Certified Quality Engineer).
• Proficiency with data analysis software such as Minitab or JMP.

Responsibilities:

• Develop, review, and execute process validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Collaborate with manufacturing and quality teams to identify critical process parameters and quality attributes.
• Analyze process data to assess process capability and identify areas for improvement.
• Prepare detailed validation reports and maintain comprehensive documentation in compliance with regulatory standards such as FDA and ISO.
• Support investigations related to process deviations, non-conformances, and implement corrective and preventive actions (CAPA).
• Participate in risk assessments and process design reviews to ensure robust and compliant manufacturing processes.
• Train and mentor manufacturing personnel on process validation requirements and best practices.

Skills:

The Process Validation Engineer utilizes analytical skills daily to interpret complex process data and ensure manufacturing consistency. Strong communication skills are essential for collaborating with cross-functional teams and documenting validation activities clearly and accurately. Technical expertise in validation protocols and regulatory standards guides the development and execution of robust validation plans. Problem-solving skills are applied to investigate deviations and implement effective corrective actions. Additionally, proficiency with statistical tools and software supports data-driven decision-making and continuous process improvement.

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