Validation Specialist

Company BackgroundPortal Insulin LLC (Portal) is a pre-clinical company developing an insulin formulation for use in treating diabetes mellitus. Portal’s primary mission is to provide a stable insulin product for use in implantable pumps.

ObjectivesThe successful candidate will be responsible for ensuring all equipment used in operations to run tests and store inventory is validated according to regulatory requirements and industry standards consistent with Portal Insulin’s SOPs. This role requires expertise in equipment validation processes, documentation, and regulatory compliance.

Reports to:Director of Quality

ResponsibilitiesInstall equipment and required monitoring devices per the manufacturer’s recommendations and consistent with Portal Insulin’s requirements. Develop and execute equipment validation protocols and reports for various types of pharmaceutical manufacturing equipment, including but not limited to packaging machinery, incubation chambers, and storage units.Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, Engineering, and Regulatory Affairs, to ensure equipment validation activities are conducted in accordance with regulatory requirements and company policies.Establish monitoring and maintenance programs to ensure equipment runs as intended, is maintained per the manufacturer’s recommendations, and is consistent with process requirements.

Typical activitiesInstall equipment and related monitoring devices.Write and execute equipment validation protocols.Analyze validation data and complete reports. Work collaboratively with project team members to release validation documentation for manufacturing and testing equipment.Set up an equipment monitoring and maintenance program.Set up and validate environmental monitoring equipment as required.

SkillsProven experience in developing and executing equipment validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).Excellent analytical and problem-solving skills, with the ability to identify and mitigate risks associated with equipment validation activities. Strong written and verbal communication skills, with the ability to communicate complex regulatory concepts to diverse audiences.Demonstrated ability to work collaboratively in a cross-functional team environment.Strong analytical and problem-solving skills with a proactive and solution-oriented approach.Able to lead through ambiguity and complex challenges

Personal CharacteristicsOrganized, focused, responsible, mature and detail-oriented.Persistent/tenacious, proactive self-starter, thorough follow-up; problem solverInitiates change. Sense of urgency.Passionate, committed to excellence, and driven to make projects and the company succeed.Comfortable wearing multiple hats.Good judgment.Takes responsibility. Gets things done personally as well as through others.Good with people; team player.Sense of humor.Demonstrated strong ethics.

BackgroundBachelor’s degree in scientific or engineering field with a minimum of 7 years of experience or Master’s degree with a minimum of 5 years of experience. Strong understanding of regulatory requirements and guidelines, including FDA regulations (21 CFR Part 11, Part 210, Part 211), EU GMP Annex 15, and ICH guidelines.Prior experience working in a consulting capacity or supporting multiple clients is preferred.