What are the responsibilities and job description for the Validation Engineer position at Stark Pharma Solutions Inc?
Job Title: Validation Engineer
Location: Massachusetts
Duration: Long Term
Job Summary
We are seeking a motivated and detail-oriented Validation Engineer to support validation activities within a GMP-regulated biopharmaceutical manufacturing environment. The Validation Engineer will be responsible for equipment qualification, process validation, utility validation, and cleaning validation activities to ensure compliance with FDA, cGMP, and industry standards.
The ideal candidate will collaborate with Manufacturing, Quality Assurance, Engineering, and Regulatory teams to support production operations, maintain validated systems, and ensure regulatory compliance across the facility.
Key Responsibilities
Location: Massachusetts
Duration: Long Term
Job Summary
We are seeking a motivated and detail-oriented Validation Engineer to support validation activities within a GMP-regulated biopharmaceutical manufacturing environment. The Validation Engineer will be responsible for equipment qualification, process validation, utility validation, and cleaning validation activities to ensure compliance with FDA, cGMP, and industry standards.
The ideal candidate will collaborate with Manufacturing, Quality Assurance, Engineering, and Regulatory teams to support production operations, maintain validated systems, and ensure regulatory compliance across the facility.
Key Responsibilities
- Develop, execute, and review validation protocols and reports including IQ, OQ, and PQ documentation
- Support equipment qualification activities for biopharmaceutical manufacturing equipment and laboratory systems
- Perform process validation for upstream and downstream manufacturing processes
- Execute cleaning validation and utility qualification activities including HVAC, purified water, compressed gases, and cleanroom systems
- Ensure compliance with FDA, cGMP, GDP, and company quality standards
- Support computerized systems validation (CSV) activities when required
- Participate in deviation investigations, root cause analysis, CAPA, and change control processes
- Collaborate with cross-functional teams during equipment installation, commissioning, and technology transfer projects
- Maintain validation lifecycle documentation including SOPs, Validation Master Plans (VMP), and risk assessments
- Assist during internal audits and regulatory inspections by providing validation documentation and technical support
- Identify and implement continuous improvement opportunities within validation and manufacturing processes
- Bachelor s degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, Biotechnology, or related field
- 3 years of validation experience in biopharmaceutical, pharmaceutical, or regulated manufacturing industries
- Strong understanding of cGMP, FDA regulations, and validation principles
- Experience with IQ/OQ/PQ protocol execution and report generation
- Knowledge of process validation, cleaning validation, and utility qualification
- Familiarity with deviation management, CAPA, and change control systems
- Strong technical writing and documentation skills
- Excellent communication, analytical, and problem-solving abilities