Inteldot has over 14 years in the life science industry with allocations across Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
The ideal candidate will be responsible for developing, executing, and documenting cleaning validation protocols. The role involves collaboration with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering.
Key Responsibilities:
- Develop and execute cleaning validation protocols.
- Conduct risk assessments and determine acceptance criteria for cleaning validation activities.
- Perform validation activities including swab sampling, rinse sampling, and reviewing analytical data.
- Write and review validation reports, Standard Operating Procedures (SOPs), and other relevant documentation.
- Investigate cleaning failures, identify root causes, and implement corrective and preventive actions (CAPAs).
- Collaborate with the production, quality, and engineering teams to troubleshoot and resolve validation-related issues.
Requirements:
- Bachelor’s degree in Science, Engineering, or a related field.
- Minimum of 3-5 years of experience in cleaning validation within a regulated environment (pharmaceutical, biotech, or medical devices).
- Strong knowledge of FDA, cGMP, and other regulatory guidelines related to cleaning validation.
- Experience in drafting, executing, and reviewing cleaning validation protocols and reports.
- Proficient in risk assessment techniques and data analysis.
- Excellent communication and documentation skills.
- Ability to work independently and as part of a team in a fast-paced environment.
- Experience with validation software and automated cleaning systems is a plus.
- Familiarity with automation systems (e.g., DCS or SCADA).