Project Manager Senior - The Steely Group

This engineering position supports projects that associated with cGMP equipment and facilities at the Thousand Oaks (ATO). The engineer will lead project engineering and construction activities in alignment with the engineering workstreams (i.e. Trades during construction, project management budget, schedules, safety, and the Commissioning and Qualification Process (CQP) to ensure that new GMP equipment is installed and maintained in a validated state, equipment & facilities design and compliance, project management, etc.).

The staff works in partnership with the maintenance, Project Management, Engineering Technical Lead, and manufacturing to develop and oversee the operation and reliability of equipment. The position must work closely with Environmental Health Safety Services (EHSS) and Quality Assurance (QA) for compliance.

The position will support the projects in defining strategies for quality systems verification and will work with the process development / validation team to develop and document appropriate practices for characterization.

Responsibilities:

• This engineering position supports projects that associated with cGMP equipment and facilities at Thousand Oaks (ATO).
• The engineer will lead project engineering and construction activities in alignment with the engineering workstreams (i.e. Trades during construction, project management budget, schedules, safety, and the Commissioning and Qualification
• Process (CQP) to ensure that new GMP equipment is installed and maintained in a validated state, equipment & facilities design and compliance, project management, etc.).
• The staff works in partnership with the maintenance, Project Management, Engineering Technical Lead, and manufacturing to develop and oversee the operation and reliability of equipment.
• The position must work closely with Environmental Health Safety Services (EHSS) and Quality Assurance (QA) for compliance.
• The position will support the projects in defining strategies for quality systems verification and will work with the process development / validation team to develop and document appropriate practices for characterization.

Basic Qualifications:

• Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Preferred Qualifications

• 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.
• 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
• 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:
• Problem solving and applied engineering.
• Basic technical report writing.
• Verbal communication