Ecocareers ยท 1 month ago
Validation Engineer
Raritan, NJ
Full-time
Onsite
Mid LevelConfidential company is seeking a talented Validation Engineer to join their team. The role involves ensuring the quality and compliance of manufacturing processes and systems through the design, implementation, and execution of validation protocols.
Staffing & Recruiting
Responsibilities
Design and develop validation protocols for SCADA technology used in the manufacture of cell and gene therapy products
Execute validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Validation (PV)
Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, Engineering, and Regulatory Affairs, to ensure alignment of validation activities with regulatory requirements and company standards
Perform risk assessments and impact analyses to identify potential validation gaps and develop mitigation strategies
Generate and maintain validation documentation, including protocols, reports, and standard operating procedures (SOPs), in compliance with regulatory guidelines and internal procedures
Conduct validation testing and data analysis to ensure the reliability, repeatability, and robustness of manufacturing processes and systems
Investigate deviations, discrepancies, and non-conformances related to validation activities and implement corrective and preventive actions (CAPAs) as necessary
Stay current on industry trends, regulatory changes, and best practices in validation engineering
Qualification
Required
Bachelor's degree in Engineering, Biology, Chemistry, or related field
Experience in validation engineering, preferably in the biopharmaceutical or pharmaceutical industry
Strong knowledge of validation principles, practices, and regulatory requirements, including FDA, EMA, and ICH guidelines
Experience with validation of equipment, utilities, facilities, and processes used in GMP manufacturing
Familiarity with risk assessment methodologies, statistical analysis, and validation documentation
Excellent analytical skills with attention to detail and accuracy
Strong communication and interpersonal skills, with the ability to collaborate effectively across functional teams
Ability to work independently and manage multiple projects simultaneously
Experience with computerized systems validation (CSV), specifically SCADA or PLC
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase