Project Engineer Job

PROJECT ENGINEER needed for a CONTRACT opportunity with Yoh's client located in Berkeley, CA

Top Skills You Should Possess:
- ICH/ISO/ISPE C&Q Baseline Guide/PDA Technical Reports

What You'll Be Doing:
- Generate facility, utility and equipment User Requirements Specifications
- Generate Validation Master Plan for C&Q activities
- Support and coordinate cGMP & Safety project reviews
- Develop and manage project equipment list and develop procurement plan
- Support Design Coordination effort
- Develop project risk assessment and develop risk mitigation activities
- Develop Engineering Change control/CCR generation
- Complete assigned activities to meet project schedule
- Communicate to core team members on progress to meet project objectives and timelines
- Work with managers and stakeholders to identify deliverables and resolve any open technical issues

What You Need to Bring to the Table:
- Two (2) plus years of experience as Lead/Project Engineer on laboratory projects (QC labs preferred) or equivalent experience in the pharmaceutical industry with a proven track record of successful delivery
- Experience with commissioning and qualification of utility systems such as air compressors and clean steam generators.
- Knowledge of ICH/ISO/ISPE C&Q Baseline Guide/PDA Technical Reports, etc.
- Knowledge of CFR requirements/EU/JP/MHRA/Canada and how to apply these requirements
- Knowledge of Risk management and Risk Analysis Tools, eg ICH 8, 9, 10
- Knowledge of best practices in the industry for development of engineering standards for pharmaceutical/biotech design/construction/operation/maintenance
- Strong understanding of QC lab operations and challenges
- Excellent verbal and written communication skills, experience with scientific technical writing including authoring and revising SOP's or technical reports

Bonus Points! Otherwise Known As Preferred Qualifications:
- BS or MS in Chemical, Mechanical Engineering or equivalent.
- Familiarity with controlled temperature environments, filter integrity testers and other manufacturing support equipment is preferred.

RECRUITER: Mary Nguyen

Yoh, a DayJ2W: ENG

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