Omiz Staffing Solutions (OSS)
Engineer - Senior (Pharma/Biotech/Medical Devices)
Omiz Staffing Solutions (OSS), Thousand Oaks, California, United States, 91362
Engineer - Senior (Pharma/Biotech/Medical Devices)
The Engineer/Project Manager role will provide direct engineering technical and project support as follows:
Be individually accountable for the deliverables on projects.
Identify, support, and/or lead implementation of engineering-based improvements or upgrades to equipment or facility systems. This may include development of business case for improvement, identification of design requirements, and translation of requirements into process equipment/system design, specifications, and supporting the construction, startup, and validation of equipment.
Develop and present project charters/strategies to leadership.
Develop accurate estimates & schedules, with cost and schedule risk analysis, cash flow analysis, and data for benchmarking.
Lead team effectiveness by identifying and efficiently resolving issues, facilitating and documenting decisions, and tracking action items, following appropriate escalation processes.
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.
Partner 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 the 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.
Preferred Qualifications / Skills / Experience
Bachelor's degree in engineering or other science-related field.
8 or more years of relevant work experience in an 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 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, Reliability Engineering, Six Sigma, and fundamental understanding of statistics, etc.).
Seniority level:
Mid-Senior level
Employment type:
Contract
Job function:
Engineering and Information Technology
Industries:
IT Services and IT Consulting
Location:
Thousand Oaks, CA
Salary:
$36.26 - $37.67 per hour
#J-18808-Ljbffr
Be individually accountable for the deliverables on projects.
Identify, support, and/or lead implementation of engineering-based improvements or upgrades to equipment or facility systems. This may include development of business case for improvement, identification of design requirements, and translation of requirements into process equipment/system design, specifications, and supporting the construction, startup, and validation of equipment.
Develop and present project charters/strategies to leadership.
Develop accurate estimates & schedules, with cost and schedule risk analysis, cash flow analysis, and data for benchmarking.
Lead team effectiveness by identifying and efficiently resolving issues, facilitating and documenting decisions, and tracking action items, following appropriate escalation processes.
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.
Partner 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 the 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.
Preferred Qualifications / Skills / Experience
Bachelor's degree in engineering or other science-related field.
8 or more years of relevant work experience in an 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 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, Reliability Engineering, Six Sigma, and fundamental understanding of statistics, etc.).
Seniority level:
Mid-Senior level
Employment type:
Contract
Job function:
Engineering and Information Technology
Industries:
IT Services and IT Consulting
Location:
Thousand Oaks, CA
Salary:
$36.26 - $37.67 per hour
#J-18808-Ljbffr