Aptask Global Workforce (AGW) is seeking a Project Engineer III for a position with a Global Pharmaceutical Company located in Fremont, CA. This is a 6+ month contract opportunity. This role serves as the Engineering technical lead on Bulk Drug Substance (BDS), Drug Product (DP), and/or Process Science (PS) systems, including upstream and downstream equipment. The successful candidate will troubleshoot equipment/process issues, lead CAPEX/OPEX projects, and manage change control and deviation/risk assessment activities within a GMP environment.
Responsibilities: - Serve as the primary consultant to troubleshoot equipment/process issues through initial qualification and system release
- Lead or participate in CAPEX/OPEX/continuous improvement projects from feasibility study to handover
- Manage medium-sized and complex equipment-related projects
- Own technical optimization and ensure facility equipment, machinery, and documentation meet compliance, quality, and EHS standards
- Lead and execute CAPA, deviation, change control, and risk assessment activities
- Lead and manage project teams, including overseeing contractor activities
- Write and review project execution plans and manage startup/commissioning activities
Requirements: - Bachelor's in Engineering with 5-10 years of related field experience, OR Master's in Engineering with 5+ years of related field experience, OR a P.E. License
- Minimum of 4 years of working experience in a GMP manufacturing environment
- Minimum 5 years of hands-on experience with process systems/equipment
- Experience and knowledge with process systems such as Bioreactors, Centrifuges, Chromatography skids and Columns, CIP/SIP, Filling, and Packaging equipment
- Capable to own and lead risk assessment, root cause investigation, and project startup/commissioning/qualification
- Expert in troubleshooting technical issues and owner of change control, deviation, and CAPA
- Project leadership experience with the ability to lead CAPEX or CI projects
- Excellent oral and written communication skills
Pay rate: up to $107.14 per hour
Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, apply today! Aptask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.
Benefits of working with ApTask Global Workforce include: - Medical
- Dental
- Vision
- Sick Pay (for applicable states/municipalities)
Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
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