Overview
On Site
Full Time
Skills
Risk Assessment
Layout
Embedded Systems
Media
Documentation
Training
Technical Drafting
Testing
Microsoft Visio
Editing
Pharmaceutics
Manufacturing
Startups
Project Management
Job Details
Responsibilities:
Requirements:
- Work alongside and supplement our client's site process engineers at the site
- Author, format, and revise SOPs, ESIs, risk assessments, verification documents, PSQ protocols, engineering protocols, and OCSs as needed.
- This will include the formatting of documents for consistency of layout; to include references to other documents and systems; embedded pictures, videos, and other media to facilitate instruction; and troubleshooting of formatting errors.
- Generate/draft training materials in parallel with procedures and other equipment/process specific documentation
- Observe equipment and system startup and C&Q activities in the facility as-needed to support document drafting and revision
- Draft documents using client's templates and following the examples laid out in existing documents generated by the site
- Work cross-functionally to support multiple departments
- Required to complete OSHA 10-hour construction training.
- Provide support drafting content for change controls
- Provide hands-on support with equipment startup and testing
Requirements:
- Bachelor Degree in Engineering or related
- Proficient in applications such as MS Word and Visio to produce and edit documents and diagrams
- Substantial experience in pharmaceutical manufacturing using single-use disposable systems
- Experience in manufacturing biologics is preferred and gene therapy a PLUS
- Startup facility experience is preferred
- Project management experience is preferred
- C&Q (commissioning, qualification) engineering experience preferred/plus
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