A validation and quality assurance provider is looking to hire a Project Engineering Manager for their Albany, NY project site. This is a 6-to-24-month assignment with possible extension. This unique group works to develop and blueprint a universally implemented validation process that reliably achieves quality, affordable and available healthcare products.
Hourly rate is $50.00 to $75.00.
Responsibilities:
- Assigned to specific capital equipment project(s)
- Work direction provided by designated Engineering resources
- Integrated into existing engineering workforce
- Assigned multiple projects and/or project tasks based on business needs
- Reports directly to Engineering Project Manager
- Execute engineering design, analysis, and documentation tasks
- Prepare technical specifications, drawings, and calculations
- Conduct engineering reviews and assessments
- Prepare and execute test protocols (e.g., FAT, SAT, change control test plan)
- Oversee equipment installation, assembly, and/or construction activities
- Support project planning, scheduling, and execution
- Participate in design reviews, safety assessments, and technical meetings
- Coordinate with cross-functional teams (Operations, QA, Facilities, etc.)
Project Management Support
- Assist in project scope development and requirements definition
- Support budget tracking and cost management activities
- Maintain and organize project documentation and records
- Prepare progress reports and status updates as requested
- Facilitate vendor/contractor coordination as directed
- Schedule meetings and generate meeting minutes
Regulatory and Compliance Activities
- Ensure designs comply with FDA, cGMP, and other applicable regulations
- Support validation activities (IQ/OQ/PQ)
- Execute and maintain documentation per client standards
DELIVERABLES
- Technical drawings and specifications
- Engineering calculations and analyses
- Project schedules and progress reports
- Risk assessments and mitigation plans
- Design review documentation
- Test protocols
- Validation and commissioning documentation
- Project status reports
Requirements:
- Bachelorâs degree in engineering (Chemical, Mechanical, Electrical, or related field)
- Minimum 5 years of Engineering experience in pharmaceutical/biotechnology industry
- Knowledge of cGMP regulations and FDA requirements
- Proficiency in relevant engineering software (MS Project, MS Excel, AutoCAD, etc.)
- Prior experience with bioprocessing equipment design, installation, and verification testing
- Project management experience
JSG has been named to three prestigious lists from Staffing Industry Analysts (SIA)âs: Largest Staffing Firms in the U.S., Largest Engineering Staffing Firms in the U.S., and Largest Staffing Firms in Canada.
Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.
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