Engineer, Sr - Validation

PLEASE NOTE THIS IS AN ONSITE ROLE IN SARASOTA FLORIDA. TRAVEL IS REQUIRED, UP TO 20% OF TIME TO SOUTH FLORIDA. THIS IS NOT A REMOTE OR HYBRID TYPE OF ROLE.

Akron Biotech is continuing to transform and further its rapidly growing capabilities and is now seeking highly motivated professionals to join our expanding team. This is an exciting opportunity to play a critical role within our organization that is driving advanced therapy development and commercialization with high quality industrial scale solutions. We manufacture and distribute components and raw materials for cell therapy discovery, development, and commercialization to meet industry needs worldwide. We offer an array of highly competitive benefits and perks to our valued associates.


Responsibilities

• Prepare validation and performance qualification protocols for new or modified processes, systems, or equipment for various production types.
• Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
• Study product characteristics/customer requirements and confer with management to determine validation objectives and standards.
• Create, populate, and maintain databases for tracking validation activities, test results, and validate systems.

• Support validation of equipment in the areas of facilities, laboratory systems, production equipment, fermentation and manufacturing.
• Assist with maintaining and revising validation procedures.
• Establish and maintain good practices with regards to processes and/or internal conditions leading to an aseptic environment.
• Establish and execute programs covering equipment, processes, cleaning, process and computer system validation.
• Assure that all validation is performed to conform to GRAM’s and cGMP requirements.
• Provide validation support to internal customers such as Technical Services, Quality Control, Manufacturing and other users of validation services.
• Write, review and execute protocols.
• Write, review and execute studies for process improvement and scale up projects.
• Provide technical support to Manufacturing – troubleshooting and resolving process related issues.
• Identify process improvement opportunities and equipment needs for manufacturing/packaging.
• Develop and execute Deviations and CAPA based on validation changes.
• Review and approve forms associated with facility and equipment calibration, maintenance, etc.
• Maintains equipment logbooks and other forms to document proper cleaning and sterilization.
• Open to a flexible and fluid work environment. Work on any assignment as directed and flexibility to support limited multi-shift operations, training and testing.
• Perform all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice.
• Support Agency, customer, and vendor audits as needed.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
• Perform all other tasks, projects, and duties as assigned.

Requirements

• Bachelors Degree in Engineering or a related field.
• 5 or more years of related work experience in life sciences manufacturing environment.
• Requires the ability to read, analyze, and interpret business information, journals, technical procedures, or governmental regulations.
• Excellent communication skills with a proven track record of writing reports and findings.
• Strong project management skills.
• Familiar with regulatory and GMP requirements for pharmaceutical manufacturing operations.
• Strong MS Office experience.