Key Responsibilities:

• Equipment Validation Support: Lead and support the temperature mapping activities and chamber requalifications in line with regulatory and industry standards.

• Validation Documentation: Ensure all validation activities, including equipment qualifications, are thoroughly documented and compliant with ISPE guidelines and U.S. Title 21 CFR Part 11 regulations for electronic records.

• Qualification and Commissioning: Participate in the qualifying and commissioning of equipment used in aseptic manufacturing processes, ensuring all systems meet required specifications.

• Compliance with Regulatory Standards: Abide by industry best practices and guidelines to ensure the validation process is compliant with Good Manufacturing Practices (GMP) and other relevant standards.

• Collaboration and Teamwork: Work closely with the validation team, consisting of 6 other full-time engineers and 2 quality assurance professionals, to ensure validation tasks are completed on schedule.

• Ongoing Validation Tasks: Manage and prioritize ongoing validation activities as part of the normal operations, ensuring all quarterly deliverables are met.

• Temperature Loggers and Ellab Loggers: Use Ellab Loggers and other temperature monitoring tools to carry out temperature mapping and ensure that equipment qualifications are performed accurately.

• Aseptic Manufacturing Activities: Support the validation team in conducting validation activities for the aseptic manufacturing processes within the facility.

• Experience: At least 3-5 years of experience in equipment validation, preferably in the pharmaceutical, biotech, or medical device industries.

• Temperature Mapping Expertise: In-depth experience with temperature mapping and chamber requalification activities.

• Knowledge of Regulatory Guidelines: Solid understanding and experience working within ISPE guidelines and U.S. Title 21 CFR Part 11 regulations for electronic records and signatures.

• Technical Tools: Familiarity with Ellab Loggers, temperature loggers, and other relevant tools for validating equipment and processes.

• Aseptic Manufacturing Experience: Experience working in aseptic manufacturing environments and supporting ongoing validation activities for aseptic processes.

• Documentation Skills: Strong skills in documenting all validation processes and ensuring proper logging of validation activities.

• Education: Bachelor's degree in a related field such as Engineering, Life Sciences, or Biotechnology (or equivalent experience).

• Team-Oriented: Ability to work effectively within a team environment, supporting team members and collaborating across departments.

• Flexible and Adaptable: Comfortable working in a fast-paced environment with the ability to manage multiple tasks and shifting priorities.

• Experience with GxP (Good Manufacturing Practices) environments and familiarity with pharmaceutical and medical device validation standards.

• Experience working on staff augmentation projects, particularly in a regulated environment.