Sr. Validation Engineer

Job Title: Senior Validation Engineer

Location: Houston, TX

Duration: 6 MONTHS (with possible extension)

Position Type: Hourly contract Position (W2 only)

Must have Qualifications:

• Experience with statistical process control (SPC) and data analysis.
• Knowledge of steam sterilization equipment and purified water system.

Job Description

Overview:

• We are seeking a highly skilled Senior Validation Engineer (Contractor) to join our Validation team. 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. This role is essential in ensuring the effective and compliant operation the equipment, contributing to the overall quality and safety of our products.

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.

Qualifications:

• 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.
• 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).
• Excellent written and verbal communication skills.
• Strong analytical and problem-solving abilities.
• Proficient in Microsoft Office Suite and validation software.
• Ability to work independently and as part of a team.

Preferred Qualifications:

• Experience with statistical process control (SPC) and data analysis.
• Knowledge of other steam sterilization equipment and purified water system.
• Certification in validation or quality assurance