USDM Life Sciences is a leading global regulatory compliance and technology firm with 20 years of experience offering bold solutions that accelerate innovation, compliance, and performance in life sciences. We are currently seeking an onsite PM/Validation Lead for our biopharmaceutical company based in Santa Monica, California.
This Validation Lead will be responsible for potentially all REGULATED applications, including ERP; LIMS; Learning Management Systems; Quality Management, etc.
- The validation lead will provide an advisory role as needed. This may include:
- Advising clients on assigning proper risk to computer systems
- Advising clients on how to meet compliance requirements.
- Advising clients on developing test that provide adequate compliance coverage as well as thoroughly tests business requirements.
- Work with client to develop validation plan to ensure that, at the end of the project, the system meets FDA compliance requirements.
- Work with client business functions and subject matter experts to develop User Requirements, Functional, and Design Specifications to establish hardware/software requirements
- Development of test / validation scripts based on software / hardware design / configuration.
- Develop Installation tests / qualifications scripts based on Design
- Develop Operation tests / qualifications scripts based on functional requirements
- Develop Performance tests / qualification scripts based on configuration
- Interact in a team environment, managing tasks and escalating issues as needed.
Education & Experience/Technical Competencies:
- University certificate or degree with a minimum of 5 years of related industry exp, or BS in Technology & 2-3 years of exp.
- Minimum 3 to 5 years in pharmaceutical industry, focusing on Systems Validation.
- Minimum of 1-2 years as a validation lead.
- Thorough understanding of the principles of GAMP, SDLC methodologies and testing best practice.
- Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems.
- Expertise in use and validation of GMP systems.
- Fluent knowledge of rules and regulations: GAMP 5, CFR Part 11 Compliance and CFR Part 210, 211 Compliance.
- Fluent in Microsoft Office suite Including (Excel, Power Point, Visio, Project)
- Ability to work independently.
- Strong organizational/ facilitation/communication skills.