US Tech Solutions
Duration:
12 months contract
Shift:
8 AM - 5 PM
Job Description The position works in partnership with the maintenance, process development, project management, engineering technical authority, and manufacturing to develop project scope, schedule, budget and lead the implementation workstream. Responsibilities include working closely with Quality Assurance (QA) for GMP and Safety for safety compliance. The engineer will support the projects in defining strategies for systems verification and will work with the process development / validation team to develop and document appropriate practices. This position supports manufacturing activities associated with cGMP equipment and facilities at company’s Thousand Oaks
Top must have skills
Engineering or construction experience in the pharmaceutical/biotechnology/regulated manufacturing industry executing on projects (Project Managing, Planning, Estimating, Cost Management, Scheduling, Technical Engineering Support, Reliability, asset management)
Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments, and equipment
Proven track record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA, LEAN, Reliability Engineering, Six Sigma, and fundamental understanding of statistics, etc.)
Responsibilities
Be individually accountable for the deliverables on projects.
Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems.
This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment
Develop and present project charters/strategies to leadership.
Developing accurate estimates & schedules, with cost and schedule risk analysis, cash flow analysis and data for benchmarking.
Leads team effectiveness by identifying and efficiently resolving issues, facilitating and documenting decisions, and tracking action items, following appropriate escalation process.
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).
Identify risks (business, quality, and safety) and develop mitigation countermeasures that are implemented.
Partnering with commissioning lead to 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).
Recommend, evaluate, and manage performance of contract resources.
Provide oversight for verification deliverables developed by outsourced/contract verification staff.
Act as a liaison between cross-functional teams 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
Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable.
Related Activities
Participate or lead, when required, multidisciplinary site teams, e.g. lead cross functional team, meeting manager, external vendor liaison, etc
Support Lean Manufacturing and Operational Excellence 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
Participate in internal audits and assess in conjunction with QA
Assist in developing and maintaining project metrics
Basic Qualifications
Doctorate degree OR
Master’s degree and 2 years of experience OR
Bachelor’s degree and 4 years of experience OR
Associates degree and 8 years of experience OR
High school diploma / GED and 10 years of experience
Preferred Qualifications
Bachelor's degree in engineering or other science-related field
8 or more years of relevant work experience in operations/manufacturing environment
5 or more years of engineering or construction experience in the pharmaceutical/biotechnology/regulated manufacturing industry executing on projects (Project Managing, Planning, Estimating, Cost Management, Scheduling, Technical Engineering Support)
Direct experience working within 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
Understanding and awareness of industry/regulatory trends for verification/validation
Strong process equipment knowledge – cell culture, fermentation, purification, filling, and packaging
Strong 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 skill
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, Reliability Engineering, Six Sigma, and fundamental understanding of statistics, etc.)
About US Tech Solutions US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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12 months contract
Shift:
8 AM - 5 PM
Job Description The position works in partnership with the maintenance, process development, project management, engineering technical authority, and manufacturing to develop project scope, schedule, budget and lead the implementation workstream. Responsibilities include working closely with Quality Assurance (QA) for GMP and Safety for safety compliance. The engineer will support the projects in defining strategies for systems verification and will work with the process development / validation team to develop and document appropriate practices. This position supports manufacturing activities associated with cGMP equipment and facilities at company’s Thousand Oaks
Top must have skills
Engineering or construction experience in the pharmaceutical/biotechnology/regulated manufacturing industry executing on projects (Project Managing, Planning, Estimating, Cost Management, Scheduling, Technical Engineering Support, Reliability, asset management)
Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments, and equipment
Proven track record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA, LEAN, Reliability Engineering, Six Sigma, and fundamental understanding of statistics, etc.)
Responsibilities
Be individually accountable for the deliverables on projects.
Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems.
This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment
Develop and present project charters/strategies to leadership.
Developing accurate estimates & schedules, with cost and schedule risk analysis, cash flow analysis and data for benchmarking.
Leads team effectiveness by identifying and efficiently resolving issues, facilitating and documenting decisions, and tracking action items, following appropriate escalation process.
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).
Identify risks (business, quality, and safety) and develop mitigation countermeasures that are implemented.
Partnering with commissioning lead to 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).
Recommend, evaluate, and manage performance of contract resources.
Provide oversight for verification deliverables developed by outsourced/contract verification staff.
Act as a liaison between cross-functional teams 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
Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable.
Related Activities
Participate or lead, when required, multidisciplinary site teams, e.g. lead cross functional team, meeting manager, external vendor liaison, etc
Support Lean Manufacturing and Operational Excellence 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
Participate in internal audits and assess in conjunction with QA
Assist in developing and maintaining project metrics
Basic Qualifications
Doctorate degree OR
Master’s degree and 2 years of experience OR
Bachelor’s degree and 4 years of experience OR
Associates degree and 8 years of experience OR
High school diploma / GED and 10 years of experience
Preferred Qualifications
Bachelor's degree in engineering or other science-related field
8 or more years of relevant work experience in operations/manufacturing environment
5 or more years of engineering or construction experience in the pharmaceutical/biotechnology/regulated manufacturing industry executing on projects (Project Managing, Planning, Estimating, Cost Management, Scheduling, Technical Engineering Support)
Direct experience working within 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
Understanding and awareness of industry/regulatory trends for verification/validation
Strong process equipment knowledge – cell culture, fermentation, purification, filling, and packaging
Strong 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 skill
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, Reliability Engineering, Six Sigma, and fundamental understanding of statistics, etc.)
About US Tech Solutions US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
#J-18808-Ljbffr