Validation Engineer II
Eclaro is looking for a Validation Engineer II for our client in Andover MA.
- Provide engineering and technical support related to the operation, maintenance, design, installation, startup/commissioning, testing, and qualification of production equipment and process systems within a biopharmaceutical manufacturing facility in Andover, Massachusetts. These systems may include production equipment such as bioreactors, fermenters, centrifuges, ultrafiltration skids, chromatography skids, Clean – In – Place (CIP) skids, and other support equipment.
- Support the operation and lead troubleshooting of manufacturing equipment and control systems used in the manufacture of biopharmaceuticals
- Support Tech Transfer activities for new products and product changeovers
- Support reliability engineering for production and support equipment
- Provide on the floor operational support as needed
- Lead/Support the design and qualification of improvements, changes, or upgrades to this equipment as needed
- Lead/Support the development of design and startup documents such as commissioning plans, User Requirement Specification (URS), Functional Requirement Specification (FRS), Configuration Specification (CS)
- Lead/Support the development and execution of commissioning, validation and qualification documents and activities
- Support the maintenance department as needed
- Provide equipment maintenance history review
- Support all investigations and audits as needed
- Support process and component improvement projects as needed
- Provide off-shift and on call support when necessary
- Will work as supplemental support for a team of engineers made up of both process and automation engineering. Must be able to work across functions collaboratively interacting with Quality representatives and manufacturing on a daily basis.
- 5 years of experience in this industry (should have a BS/MS in BioMedical or Chemical Engineering or relevant discipline (ie. Biomechanical Engineering)
- Working knowledge of automated production systems with ability to manipulate and troubleshoot systems.
- Working knowledge of documents such as Piping & Instrumentation Diagrams (P&IDs), User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Configuration Specifications (CS), and Qualification documents.
- Candidate should have a BS/MS in BioMedical or Chemical Engineering or relevant discipline (ie. Biomechanical Engineering)
- Candidates should have 5 years of experience in this industry
- Candidate must be able to work across functional areas such as operations, maintenance, quality and regulatory.
- Good communication skills, verbal and written, are required.
- Knowledge of working with computers and associated applications such as MS Word, Excel, and PowerPoint are recommended.
- Knowledge of database applications are a plus.
Interested in applying? Contact Joy Retanan at (646) 695-2949 or at http://www.linkedin.com/pub/joy-retanan/85/4ba/333 or send your resume to Joy.Retanan@eclaro.com now. Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.