Job Title: Engineering Validation Specialist
We are seeking a highly skilled and experienced Engineering Validation Specialist to join our team. The successful candidate will be responsible for ensuring the quality of our products by designing, authoring, reviewing, and approving qualification/validation documentation and cycle development studies. Key responsibilities include:
• Designing, authoring, reviewing, and approving qualification/validation documentation and cycle development studies
• Ensuring compliance with current Good Manufacturing Practices (cGMP) and regulatory requirements
• Collaborating with production, maintenance, and quality representatives to resolve technical issues and ensure smooth operations
• Providing technical input into quality notifications and investigations
• Performing root cause analysis of system failures and substandard performance using standard tools and methods
• Supporting continuous improvement through Lean Six Sigma methodologies
• Serving as validation representative for cross-functional projects and representing the validation team at global technical forums
• Maintaining accurate records and reports on qualification/validation activities and results
Required Skills and Qualifications:
• Relevant technical qualification(s) in Applied Pharmaceutical/Biological/Chemical sciences or applied Technical/Engineering qualification
• At least 3-4 years of experience in authoring, reviewing, executing, and approving Isolator Airflow Visualization/HVAC Qualification documents
• Considerable experience in a comparable role, with experience operating as an individual contributor adding value to the business in a GMP manufacturing setting
• Excellent communication, presentation, and interpersonal skills, with the ability to interface effectively with all levels of colleagues and external customers
• Proficiency in Microsoft Office and job-related computer applications
Benefits:
• Opportunity to work with a leading Biopharma company
• Competitive salary and benefits package
• Professional development and growth opportunities
• Collaborative and dynamic work environment
If you have a passion for quality and excellence, and are looking for a challenging and rewarding role, we encourage you to apply.