Project Manager
US Tech Solutions
- Thousand Oaks, CA
- Contract
- Full-time
- Be individually accountable for the verification deliverables on key capital projects
- Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.
- Assist in development and review of User Requirements Specifications (URS).
- Suggest design modifications to address risks and design in quality and safety.
- Develop the commissioning strategy based on the URS and Quality Risk Assessment for Automation and Equipment Systems (QRAES) to validate equipment design while minimizing project cost and schedule impact (risk-based approach).
- Oversee development of validation protocols in line with CQP, Automation Systems Delivery SOPs, and cGMP standards.
- Recommend, evaluate, and manage performance of contract resources
- Provide oversight for verification deliverables developed by outsourced/contract verification staff.
- Act as a liaison between Engineering and Quality Assurance during project planning, execution, and closeout
- Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices.
- Ensure safety during commissioning, validation, maintenance, and manufacturing activities
- Review and approve the commissioning report and ensure that all verification exceptions have been adequately addressed
- Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable
- Suggest design modifications to address risks and design in quality and safety
- Develop commission strategy
- Oversee development of validation protocols, Automation System Delivery
- Lead teams
- Participate or lead, when required, multidisciplinary site teams, e.g. Cross Functional Team, Root Cause Analysis lead.
- Support Lean Transformation and Excellence in Operations process improvement by leading, supporting, and documenting improvement opportunities to reduce cost, improve safety/quality, or improve speed.
- Provide ad hoc technical support and guidance for manufacturing and maintenance
- Assist in developing and project engineering & management metrics
- Bachelor's degree in engineering or another science-related field
- 2+ years of relevant work experience with 1+ years’ experience in operations/manufacturing environment
- Direct experience with regulated environments (FDA, OSHA, EPA, etc.)
- Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments and equipment
- Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and execution
- Experience with combination product / medical device quality systems verification
- Process equipment knowledge – cell culture, fermentation, purification, filling, and packaging
- Process automation knowledge – understanding of automation infrastructure, current technologies, and automation project execution / verification.
- Demonstrated strong communication and technical writing skills
- Strengths in facilitation and collaboration / networking
- Experience in developing SOPs and delivering training
- Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making
- Good record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA, LEAN, Six Sigma, and fundamental understanding of statistics, etc.)
- Demonstrated skills in the following areas:
- Demonstrated Skills in the following areas:
- Specialized equipment/process expertise.
- Ability to handle multiple projects at the same time.
- Demonstrated Skills in the following areas:
- Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
- Demonstrated Skills in the following areas: