Targeting Validation Engineer

Targeting Validation Engineer ROCGJP00027886

A leading biotechnology company is seeking a Targeting Validation Engineer. The successful candidate will be accountable for supporting validation activities and validation change management system for validated equipment, utilities, and facilities such as Critical Assessment (CA), System Impact Assessment (SIA), Requirements Trace Matrix (RTM), Data Integrity Assessment (DIA), User Requirements (URS) and protocol generations relevant to validation activities. The ideal candidate has two to five years of experience in process engineering, validation engineering, or technical services.

Targeting Validation Engineer Pay and Benefits:

• Hourly pay: $35-$45/hr
• Worksite: Leading biotechnology company (Hillsboro, OR 97124 - Onsite)
• W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL
• 40 hours/week, 10 Month Assignment

Targeting Validation Engineer Responsibilities:

• Support the development, execution, and management of the timelines for the execution of CA/SIA/RTM/DIA/URS activities.
• Track and trend activities and report on issues such as impact to predetermined timelines and problems as needed.
• Support validation activities and coordinate the collection, testing and analysis of samples and reporting of results required per validation protocol.
• Support the change management system for validated equipment, utilities, and facilities.
• Assist with the preparation and review of relevant sections of protocol generations/approvals processes.
• Serve as a representative on cross-functional and multi-site teams.
• Support development of formulation, filling, and packaging, area SOP’s and manufacturing documents as appropriate.
• Foster an environment that encourages continuous learning. Maintain expertise as necessary to stay abreast of technical and industry advancements.

Targeting Validation Engineer Qualifications:

• 2-5 years of experience in process engineering, validation engineering, or technical services.
• BS in chemical, biochemical engineering, or related field/experience.
• Cleaning and Sterilization qualification experience.
• Experience in the pharma/biotech industry is a plus.
• Knowledge of cGMPs or equivalent regulations.
• Strong in Technical Writing.
• Working knowledge of formulation, filling, inspection, and packaging equipment qualification in a regulated environment.
• Demonstrated understanding of project management skills.
• Ability to work with internal teams, partners, suppliers and customers.
• Operational excellence and industrial engineering skills are a plus.
• Professional level written and oral communication skills.