Lead validation activities for equipment, facility, utilities, cleaning and sterilization validation for a project to qualify an isolator-based aseptic manufacturing suite. Provide technical expertise to the cross-functional project team and field execution support to ensure aseptic manufacturing facility, processes and support systems are in compliance with company validation guidelines and CGMP regulations.
Execute and provide oversight of validation activities for manufacturing equipment, utilities, automation, cleaning and sterilization validation to support the aseptic manufacturing facility project. Work closely with Engineering to support the commissioning effort and provide technical expertise, as required.
Responsible for authoring, executing and review/approval of commissioning documentation, validation protocols, reports and support records to ensure compliance with local procedures; timely resolution of documentation, compliance, and quality system issues.
Support the development of validation execution strategy and timeline with validation management and project team for manufacturing equipment, utilities, automation, cleaning and sterilization validation.
Work with contractors and equipment vendors, as necessary, to ensure validation packages are provided and completed to the required standards, on schedule.
Oversee validation consultants and their scope to facilitate validation deliverables for the project. Work with Quality and Validation management to resolve any discrepancies.
Ensure proper validation protocols and reports are developed and followed to ensure compliance with pharmaceutical industry requirements and regulations (e.g., FDA, EMA, PIC/S). Leads continuous quality system improvements for the validation program.
Responsible for supporting internal and external inspections as a subject matter expert for validation and provide audit support, as required.
Working hours: 8-5
Master's degree in science or engineering with 5 years of experience or Bachelor's degree in science or engineering with 7 years of experience in pharmaceutical or biopharmaceutical industry with at least 2 years in validation.
Validation experience with HVAC, utilities, and vial filling line equipment and cleaning and sterilization cycle development and validation experience is desired.
Aseptic fill-finish experience, including familiarity with validation of aseptic manufacturing technologies and facilities is preferred.
Demonstrated ability to manage major to complex validation projects efficiently.
Demonstrated ability to effectively write technical documents, including test plans, protocols and reports.
Ability to recommend, judge, and make good decisions in complex situations
Strong organizational, presentation and communication skills.
Experience using project management tools is a plus.
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