Deviation Specialist Job

DEVIATION SPECIALIST needed for a CONTRACT opportunity with Yoh's client located in SAN CARLOS, CA

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- cGMP
- SOP
- DR/CAPA/Change Control

WHAT YOU'LL BE DOING:

- Provides technical support with multiple unit operations.
- Develops/approves standard operating procedures and batch records, reviews/approves design documents, leads investigations, solves problems to root cause, implements corrective actions, implements change controls, operates automated equipment, executes standard operating procedures, executes validation qualifications, trains others on unit operations, and leads improvement projects.
- Troubleshoots complex equipment related issues and develops sound engineering solutions to address identified problems.
- Lead site based deviation reduction effort
- Accountable for metrics related to DR/CAPA/Change Control on-time closure, as well as CAPA effectiveness
- Drives efficiencies and improvements to the deviation management system
- Serve as a mentor to other during complex investigations, and train others on deviation management systems.
- Provides support with multiple business process systems to support all areas of manufacturing.
- These system include SAP, LIMS, Data Historian, and Sentry/Trackwise
- Leads complex deviation (DR) investigations to adequately identify root cause and implement appropriate corrective and preventative actions (CAPAs) to prevent reoccurrence.
- Demonstrated mastery of NVD root cause analysis, investigation tools and methodologies.
- Mentors other investigators to develop toward mastery.
- Leader in identification and implementation of complex continuous improvement projects to improve yield, reliability, and/or process robustness.
- This will require leading and implementing change controls.
- Independently leads cross functional teams for engineering projects, business systems and complex change controls.
- Supports the development of manufacturing standards and best practices.
- Develops and maintains departmental metrics and key performance indicators (KPIs).
- Provides training and technical among manufacturing team.
- Responsible for scheduling manufacturing activities as well as coordinating equipment maintenance and validation, as needed.
- Mentor to other individual contributors, providing both technical and career development guidance.
- Responsible for coordinating activities to support departmental operation.
- Ensures manufacturing goals are achieved through robust safety practices and quality compliance.
- Integrate with the technology transfer teams to serve as the Operations interface with Project Management, Process Engineering, Technology, and Automation.
- At times may lead or manage aspects of a Tech Transfer.
- Responsible for leading and participating in inspection readiness activities.

WHAT YOU NEED TO BRING TO THE TABLE:

- Responsible for providing technical operations, engineering and business process support to second-ary manufacturing areas.
- Direct experience with cGMP environments required
- Experience developing SOPs and documenting work
- Advanced mechanical aptitude or knowledge of electronic/mechanical equipment
- Experience working with formulation, filling, automated inspection, and/or packaging equipment is preferred.
- Prior experience working on technology transfer of vaccine or drug products is preferred.
- Experience participating in regulatory inspections preferred.
- Experience utilizing Lean and OEE principles is preferred.

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- Bachelor's degree in Engineering with five (5+) years experience OR bachelor's degree in science related discipline with six (6+) years related industry OR equivalent industry experience (pharmaceutical, biotechnology, and/or sterile production environments).

RECRUITER:Mary Nguyen

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

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