Project Manager - Calsoft Labs
Thousand Oaks, CA 91320
About the Job
FULLY ONSITE AT USTO
Standard business hours
Looking for a PM who will support manufacturing plant/ engineering group
***Copy of AMAGJP00011920. Please do not resub previously presented candidates. EM FEEDBACK FROM CANDIDATE POOL: It seemed like the applicant pool lacked process/utility Engineering technical experience and was more suited for quality roles***
This engineering position supports projects that associated with cGMP equipment and facilities at Client Thousand Oaks (ATO). The engineer will lead activities in alignment with the engineering workstreams (i.e. Clients 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 engineer works in partnership with the maintenance, Project Management, Engineering Technical Lead, and manufacturing to develop and oversee the operation and reliability of equipment. The engineer must work closely with Environmental Health Safety Services (EHSS) and Quality Assurance (QA) for compliance. The engineer 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.
The Engineer role will provide direct engineering technical support as follows:
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
Related Activities:
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
Preferred Qualifications / Skills / Experience
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.
o 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.
Demonstrated Skills in the following areas:
Basic technical presentations.
Personal Organization.
Dealing with and managing change.
Technical (Equipment Specific).
Analytical Problem Solving.
Computer Literacy (Maximo, Track wise, E-Builder, PCS, Client and QEMS).
Specialized equipment/process expertise.
Ability to handle multiple projects at the same time.
Demonstrated Skills in the following areas:
Schedule development
Facilitation
Collaboration
Basic project management
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.
Demonstrated Skills in the following areas:
Negotiation, persuasion, and facilitation collaboration
Project cost development
Conflict resolution
Leadership and team building
Schedule and resources loading development
Customer service in a technical setting
Management of contractors and vendors.
Flexibility to work off-hours.
Standard business hours
Looking for a PM who will support manufacturing plant/ engineering group
***Copy of AMAGJP00011920. Please do not resub previously presented candidates. EM FEEDBACK FROM CANDIDATE POOL: It seemed like the applicant pool lacked process/utility Engineering technical experience and was more suited for quality roles***
This engineering position supports projects that associated with cGMP equipment and facilities at Client Thousand Oaks (ATO). The engineer will lead activities in alignment with the engineering workstreams (i.e. Clients 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 engineer works in partnership with the maintenance, Project Management, Engineering Technical Lead, and manufacturing to develop and oversee the operation and reliability of equipment. The engineer must work closely with Environmental Health Safety Services (EHSS) and Quality Assurance (QA) for compliance. The engineer 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.
The Engineer role will provide direct engineering technical support as follows:
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
Related Activities:
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
Preferred Qualifications / Skills / Experience
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.
o 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.
Demonstrated Skills in the following areas:
Basic technical presentations.
Personal Organization.
Dealing with and managing change.
Technical (Equipment Specific).
Analytical Problem Solving.
Computer Literacy (Maximo, Track wise, E-Builder, PCS, Client and QEMS).
Specialized equipment/process expertise.
Ability to handle multiple projects at the same time.
Demonstrated Skills in the following areas:
Schedule development
Facilitation
Collaboration
Basic project management
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.
Demonstrated Skills in the following areas:
Negotiation, persuasion, and facilitation collaboration
Project cost development
Conflict resolution
Leadership and team building
Schedule and resources loading development
Customer service in a technical setting
Management of contractors and vendors.
Flexibility to work off-hours.
Source : Calsoft Labs