Company:
Spark Life Solutions, Inc.
Location: Boston
Closing Date: 21/10/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
Roles & 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.
- Bachelor's or Master's degree in Engineering (Chemical, Mechanical, Biomedical, or related field).
- Minimum of 5 years of experience in CQV within the pharmaceutical or biotechnology industry.
- Proven experience with commissioning and qualification of equipment such as bioreactors, chromatography systems, and HVAC systems.
- Experience in cleanroom environments and understanding of contamination control measures.
- Strong understanding of regulatory requirements (FDA, EMA, ICH, cGMP).
- Proficiency in developing and executing IQ/OQ/PQ protocols.
- Knowledge of risk assessment tools and methodologies.
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Spark Life Solutions, Inc.