Validation Engineer I

About the role

As a Validation Engineer I, you will be responsible for the design, implementation, and execution of equipment validation activities to ensure the compliance, quality, and efficacy of our manufacturing processes. You will work closely with cross-functional teams to develop and execute validation strategies, provide technical expertise in equipment validation, and ensure adherence to regulatory requirements.

Responsibilities

• Bachelor's or degree in Engineering, Biotechnology, Pharmaceutical Sciences, or a related field (or equivalent experience).
• Experience in equipment validation within a regulated industry.
• Experience in qualifying a wide range of equipment, including Isolators, Filling & Capping equipment, Biological Safety Cabinets (BSCs), Controlled Temperature Units (CTUs), bioreactors, incubators, chromatography systems, and centrifuges.
• Understanding of aseptic processing and clean room standards.
• Proficiency in risk assessment methodologies.
• Understanding of cGMPs (current Good Manufacturing Practices).
• Excellent analytical, problem-solving, and decision-making skills, with meticulous attention to detail.
• Effective communication and collaboration abilities, with the capacity to work cross-functionally and influence stakeholders at various levels of the organization.
• Strong project management skills, with the ability to prioritize and manage multiple validation projects concurrently.
• Ability to work in a cleanroom environment while wearing appropriate gowning and PPE up to 50% of the time.

Qualifications

• Bachelor's or degree in Engineering, Biotechnology, Pharmaceutical Sciences, or a related field (or equivalent experience).
• Experience in equipment validation within the pharmaceutical or biotechnology industry.
• Experience in qualifying a wide range of equipment, including Isolators, Filling & Capping equipment, Biological Safety Cabinets (BSCs), Controlled Temperature Units (CTUs), bioreactors, incubators, chromatography systems, and centrifuges.
• Experience with aseptic processing and clean room standards.
• Proficiency in risk assessment methodologies.
• Strong understanding of cGMPs (current Good Manufacturing Practices).
• Excellent analytical, problem-solving, and decision-making skills, with meticulous attention to detail.
• Effective communication and collaboration abilities, with the capacity to work cross-functionally and influence stakeholders at various levels of the organization.
• Strong project management skills, with the ability to prioritize and manage multiple validation projects concurrently.
• Ability to work in a cleanroom environment while wearing appropriate gowning and PPE up to 50% of the time.

Preferred Skills

• Experience in the Cell & Gene Therapy Industry.
• Knowledge of validation principles across multiple disciplines, which may include computerized systems, aseptic process simulation, and/or process validation.
• Experience in the application of pre-clinical, clinical, and commercial cGMPs.