Hi,
My name is Sravani Dasari from Stark Pharma Solutions Inc. We are hiring talent for our client and are currently working on a Manufacturing Validation Engineer position. Please send me your updated resume if you have relevant experience and are interested in this opportunity. The detailed job description is as follows.
Job Title: Manufacturing Validation Engineer
Location: Lake County, IL
Duration: Long Term
Position Overview
We are seeking an experienced
Manufacturing Validation Engineer to support manufacturing operations by executing validation activities, equipment qualification, and process validation initiatives within a regulated pharmaceutical or medical device environment. The ideal candidate will have hands-on experience with IQ/OQ/PQ, CQV, GMP compliance, validation documentation, and cross-functional collaboration to ensure manufacturing processes meet quality and regulatory standards.
Key Responsibilities
- Execute Manufacturing Validation activities for equipment, utilities, and manufacturing processes.
- Perform Equipment Qualification including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Develop, review, and execute validation protocols, reports, and supporting documentation.
- Support Process Validation activities to ensure consistent manufacturing performance and product quality.
- Ensure compliance with GMP, FDA, ISO, and internal quality system requirements.
- Collaborate with Manufacturing, Engineering, Quality Assurance, and Validation teams to support production readiness.
- Investigate deviations, support CAPA implementation, and participate in root cause analysis.
- Maintain validation lifecycle documentation and ensure all records are audit-ready.
- Assist with commissioning, qualification, and validation (CQV) activities for new equipment and manufacturing systems.
- Participate in continuous improvement initiatives to enhance manufacturing efficiency and compliance.
Required Qualifications
- Bachelor's or Master's degree in Engineering or a related technical discipline.
- Experience in Manufacturing Validation, CQV, Equipment Qualification, or Process Validation within the pharmaceutical, biotechnology, or medical device industry.
- Hands-on experience performing IQ, OQ, and PQ activities.
- Strong understanding of GMP, FDA regulations, ISO standards, and validation principles.
- Experience preparing and reviewing validation protocols, reports, and technical documentation.
- Knowledge of deviation investigations, CAPA, change control, and risk assessment processes.
- Excellent analytical, troubleshooting, documentation, and communication skills.
- Ability to work effectively with cross-functional teams in a regulated manufacturing environment.
- Experience supporting regulatory audits and maintaining compliance documentation is preferred.
- Familiarity with computerized systems validation (CSV), cleaning validation, or utility qualification is an added advantage.
I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.
Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/
