Job Description

• Engineering and technical background (process equipment, troubleshooting, data-driven tech skills)
• Teamwork experience
• Project improvement background

• Be individually accountable for the verification deliverables
• 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.
• Oversee development of validation protocols in line with CQP, Automation Systems Delivery SOPs, and standards.
• Act as a liaison between Engineering and Manufacturing 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.
• Related Activities:
• 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
• Provide coaching and guidance to project teams and engineers on the CQP process and risk-based approaches to commissioning and verification
• Assist in developing and maintaining metrics
• Provide concise and clear documentation for actions taken on systems
• Oversee equipment vendors and contractors.

• Master’s degree OR
• Bachelor’s degree & 2 years of engineering and/or manufacturing experience OR
• Associate’s degree & 6 years of engineering and/or manufacturing experience OR
• High school diploma / GED & 8 years of engineering and/or manufacturing experience

• Bachelor's degree in engineering-related field
• 5+ years of relevant work experience with 3+ 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 process equipment / automation projects, including validation protocol development and execution
• Process equipment knowledge – cell culture, fermentation, purification, filling, and packaging
• Process automation knowledge – understanding of automation infrastructure, current technologies, and automation project execution / verification.
• Knowledge of Delta V, Rockwell, and Plant Information Systems is a plus
• 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
• Proven track record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA, LEAN, Six Sigma, and fundamental understanding of statistics, etc.)
• Problem solving and applied engineering.
• Basic technical report writing and presentations
• Verbal communication
• Personal Organization
• Dealing with and managing change
• Technical (Equipment Specific)
• Analytical Problem Solving
• Computer Literacy (Maximo, Track wise, E-Builder, PCS, BMS and QEMS)
• Specialized equipment/process expertise
• Ability to handle multiple projects at the same time
• Schedule development, Facilitation and collaboration
• Basic project management, project completion and follow-up
• Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
• Negotiation, persuasion and facilitation Collaboration
• Project Cost development
• Conflict Resolution
• Customer service in a technical setting
• Management of contractors and vendors.
• Flexibility to work off-hours and fully on-site

• No work experience
• No engineering or technical experience
• No collaboration experience