Validation Engineer jobs in Missouri

Job Requirements:

• Must have experience developing and reviewing URS, vender qualifications, IQ/OQ documentation, PQ protocols for analytical instrument/computerized systems.
• Must have Engineering or Science degree and 5 years of validation engineering experience
• HIGHLY preferable to have experience with chillers and freezers
• Working with or awareness of pharmaceutical standards, rules and guidance (e.g. FDA, EU, ISO, ISPE, etc.).
• Additional validation experience that may include analytical equipment, associated software, and temperature unit validation.
• Ability to utilize GDP during document creation and review.
• Comfortable in a fast-paced environment with the ability to adjust to changing priorities. Flexible and accountable.

Basic Job Description:

• The Validation Engineer will be the support cleanroom qualifications, analytical instrument qualifications, and computerized system qualifications. This role supports the manufacturing of pharmaceuticals in a cGMP manufacturing facility.
• Provide support to Engineering, Maintenance, Manufacturing, and QA teams during Protocol execution.
• Work cross-functionally with Project Management, Quality Control, Quality Assurance, Materials Management, Engineering, Information Technology (IT), and Maintenance.
• Develop and review URS, vender qualifications, IQ/OQ documentation, PQ protocols for analytical instrument/computerized systems.
• Analyze results from Engineering Studies to make conclusions and recommendations.
• Author and review detailed design documents for analytical instruments/computerized systems.
• Determine the impact of proposed changes on the validated state of analytical instruments/computerized systems.
• Create and execute qualification protocols for equipment, analytical instrumentation, and facility. (including but not limited to FAT/SAT/IOQ and PQ documents)
• Utilize GDP in a GMP atmosphere while generating protocols and reviewing documents.
• Review and generate closing reports for executed protocols.
• Create validation schedules, coordinate execution efforts with contractors, production operators, production engineers, customers and quality assurance staff members.
• Ability to work through a Management of Change system to determine the impact of proposed changes to the qualification status of equipment, software, or facilities.
• Sound understanding of Quality Risk Management concepts.

Job Responsibilities:

• Equipment, Analytical Instrument and Facility Validation:
• Develop/Establish an overall plan for qualifying new equipment/instrument or new/upgraded facility and establishing the proper controls for the introduction of equipment/instrument/facility and/or changes under proper quality standards (e.g. FDA, EU, ISO, ISPE, etc.)
• Identify and establish revalidation requirements.
• Write and execute qualification packages, technical reports, and validation master plans
• Qualification project priority will be Controlled Temperature Unit qualifications. Secondary priority will be Analytical Instrument qualifications.
• Conduct Annual Validation Reviews (Annual Reporting)
• Conduct the annual review to identify temperature excursions for Controlled Temperature Units