Validation Engineer

We at Azzur Group are looking for an experienced Validation Engineer to immediately join our Azzur

Consulting: Chicago team. The Validation Engineer is an FTE project based role. The Validation

Engineer is responsible for the theory and content of validation documents for new cleanrooms and

packaging equipment, including utilities qualification, cleanroom qualification, and

FAT/SAT/IQ/OQ/PQ of a new packaging line. This will ensure that validation documentation is

compliant with site and corporate validation requirements and policies as well as compendial (e.g.,

USP) and regulatory (e.g., FDA) expectations/regulations.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Writes procedures, investigations, protocols, reports, change controls, etc. to support the Maintenance and Engineering, Validation, Quality, and Regulatory departments. 

• Generates validation life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, sterilization, shipping, and processes validation and facilities, utilities, systems, equipment qualification/requalification.
• Writes and revises a variety of Installation, Operation and
• Performance qualification/verification related documents, including any of all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation test plans, engineering design reviews, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), and/or commissioning test procedures.
• Performs on site or support work for a client under supervision, including but not limited to:
• Validation protocol execution for FAT/SAT/IQ/OQ/PQ, thermal mapping of temperature-controlled chambers, warehouses, and sterilization processes
• Equipment Qualification test execution
• Investigations and deviations
• Risk analysis, and/or
• Data integrity assessments and review of client data
• Executes protocols and helps resolve deviations/discrepancies,

Requirements

QUALIFICATIONS AND REQUIREMENTS:

• Bachelors Degree in engineering, science, or similar field or equivalent experience
• 2-5 years experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry
• Experience in executing protocols including systems such as Process Validation, utilities manufacturing equipment and basic knowledge of laboratory validation
• Experience with temperature mapping
• Experience with many aspects of validation
• Working knowledge of FDA and cGMP regulations and documentation practice
• Ability to read and interpret Piping and Instrument Diagrams (P&ID), and electrical systems
• Must have ability to travel 25%

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k, IRA)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)
• Family Leave (Maternity, Paternity)