*Please answer the questions below when you apply to this position*

Our client is a growing company the in the personal care products industry. This position is in Ottawa, IL (85 miles SW of downtown Chicago) has an immediate need for a Manufacturing Process Validation Engineer. The Validation Engineer will support validation of laboratory systems, cGMP equipment, facilities, and processes: Including Batch Homogeneity, Hold Time Studies, Cleaning & Sanitation Validation, Equipment Commissioning, Filling and Packaging Qualification, Water Systems, Compressed Air Systems, etc.

ESSENTIAL DUTIES AND RESPONSIBILITIES
Write, review, and execute protocols.
Write, review, and execute studies for process improvement and new product launch.
Maintains equipment logbooks and other forms to document use, proper cleaning and sterilization.
Provide validation support to internal customers such as Maintenance, Quality, Regulatory Affairs, R&D, Manufacturing and other users of validation services.
Assure that all validation are performed in compliance with cGMP requirements and ISPE standards.
Establish and maintain good practices in association with processes and/or internal conditions leading to an environment consistently within a state of control.
Strong attention to detail; Ability to complete tasks with accuracy and efficiency.
Ability to interpret and relate Quality and Best Practice Qualification and Validation standards for implementation and review.
IQ/OQ/PQ activities for facilities/utilities
Completing Change Controls for Manufacturing Equipment, Processes, Facility/Utility Systems
Completing Periodic Reviews, and re-validation of manufacturing processes and equipment, as well as Facility and Utility Systems.


Principle Requirements:
• 3-5 years of experience of manufacturing process validation work (pharma or medical devices)
• Experience with equipment IQ/OQ/PQ protocol development and execution
• Refrigerator/Freezer/Incubator Temperature Mapping Experience
• Facility/Utility validations (HVAC, RODI/Purified Water/Compressed Gases)
• Experience with Change Control Documentation
• Experience with creating engineering change control documents and testing protocols associated with change controls

Desired Experience:
• Experience completing Periodic Reviews for Validation Packages
• Experience with Software Validation and Part 11 Compliance issues

This is an immediate need. This position pays a competitive salary and full benefits package. This job is ideal for someone who is dependable, adaptable/flexible and details oriented and can thrive in a fast pace environment.

If you or anyone you know is interested, qualified and immediately available please answer the below questions and send an updated resume to us for immediate review and consideration. Candidates are required to answer the below questions when applying:

1. Do you have reliable transportation to Ottawa, IL 5-day a week?
2. How soon are you able to start this full-time position in Ottawa, IL?
3. Do you have IQ/OQ/PQ protocol development and execution?
4. How many years of Manufacturing validation experience do you have with pharma or medical devices?
5. What annual salary to you require to accept this position?