Job description
We are hiring a Validation Engineer for an onsite role in Houston, TX! The ideal candidate will possess a minimum of 5 years of experience in the pharmaceutical or medical device industry, with a proven track record in autoclave (sterilizer), Purified water System, Pure Steam validation.
Details:
- $41 - $68.94 per hour pay rate
- Full Time
- Contract -6 months
- Onsite in Houston, TX
What's in it for you?
- Health, Dental, Vision insurance offered
- 401k options
- Work with a great team!
Only considering candidates with the following:
- Bachelor's degree in Engineering, Science, or a related field.
- Minimum of 5 years of experience in autoclave/sterilizer validation within the pharmaceutical or medical device industry.
- Experience with statistical process control (SPC) and data analysis.
- Knowledge of steam sterilization equipment and purified water system.
- In-depth knowledge (SME Level) of autoclave/sterilizer principles, operation, and maintenance.
- Experience with Control Systems (PLC, HMI, SCADA).
- Experience in Computer System Validation.
- Experienced in Qualifying Purified water system, and Pure Steam Generators.
- Experience using Temperature Dataloggers like Kaye AVS, Ellab EValPro.
- Strong understanding of validation methodologies and regulatory requirements (FDA, EMA, GMP, ISO).
Responsibilities:
- Develop, execute, and review comprehensive validation protocols for autoclaves and sterilizers, including Installation Qualification (IQ), Operational
- Qualification (OQ), and Performance Qualification (PQ).
- Conduct thorough risk assessments to identify potential equipment and process-related risks and implement effective mitigation strategies.
- Collaborate with cross-functional teams, including engineering, production, and quality assurance, to ensure seamless validation execution and compliance.
- Author and maintain detailed validation documentation, including protocols, reports, and deviations.
- Investigate and resolve validation-related deviations and out-of-specification results, implementing corrective and preventive actions (CAPAs) as needed.
- Stay up-to-date with industry regulations and standards (e.g., FDA, EMA, GMP, ISO) to ensure compliance.
- Provide technical expertise and support for autoclave/sterilizer-related inquiries and investigations.
- Participate in continuous improvement initiatives to enhance validation processes and efficiency.
