Address
Form of work
SalaryDiscGenics is a privately-held, clinical stage biopharmaceutical company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine.
The Validations Engineer will work with all aspects and departments within the company, being exposed to and supporting laboratories (R&D, QC, microbiology) facilities (ISO 5 through 8 and CNC), clean/sterile utilities, quality systems and databases (CMMS and ERP and Building Automation Systems), and production operations (upstream, downstream, and final fill / packaging).
Essential Duties and Responsibilities:
Job Requirements:
Education and Experience:
Working Conditions:
Disclaimer:
Summary:
The Validations Engineer will fill an important need at DiscGenics through helping the company to be ready for commercial GMP production and providing support to validation technicians. This position will also oversee supplier/vendor validation efforts as needed and representing DiscGenics’ standards of quality and engineering.
The Validations Engineer will work with all aspects and departments within the company, being exposed to and supporting laboratories (R&D, QC, microbiology) facilities (ISO 5 through 8 and CNC), clean/sterile utilities, quality systems and databases (CMMS and ERP and Building Automation Systems), and production operations (upstream, downstream, and final fill / packaging).
The Senior Validations Engineer will help support potential vendor and/or contractor validation services and will be able to touch upon some supervisory activities of outside consultants.
Essential Duties and Responsibilities:
- Technical lead on validation of autoclaves, steam generators, bioreactors, filler/labeler, databases, and new lab/facility.
- Support qualification of laboratory instruments for QC and Microbiology.
- Support/Lead media fill (aseptic simulations) for sterile fill/finish operations
- Mentor validation technicians in their assigned validation and qualification and commissioning efforts of facility/utility/equipment.
- Support development of validation program and validation governing SOPs and templates for standard efforts.
- Draft validation protocols, and review validation technician’s protocols.
- Review and approve validation technician’s summary reports.
- Support validation management in planning for and look ahead during Validation Project Plan development.
- Support process engineer efforts for pre-validation, risk assessment, and quality by design efforts.
- Support process validation (PPQ) and PQ’s including mixing studies, freezing/thaw studies, equipment cleaning studies, facility cleaning studies.
- Write Validation Project Plans (VPPs) for groups of systems to bring a facility online for startup and new product commercial launch.
- Other duties as assigned
Job Requirements:
- Must have 3-5 years of experience in validation or a pharmaceutical/biologics/cell therapy facility.
- Experience with analytical QC/Microbiological instruments and tests in a GLP/GMP environment and is familiar with new equipment qualification.
- Exposure to facilities/utilities/equipment in a GxP environment and is familiar with qualification of various equipment.
- Independence and creative problem-solving abilities.
- Ability to handle highly confidential business information.
- Exceptional time management and multi-tasking skills.
- Team leadership skills and team player.
- Adheres to and leads with the Company Values of Integrity, Innovation, Accuracy, Team Work and Stewardship.
- Regular and predictable attendance.
- Ability to report to work responsive, free from sedatives, and in a non-sedative state.
- Proficient with Microsoft Office, including Word, Excel, and PowerPoint.
Education and Experience:
- B.S./B.A. in Engineering, Microbiology, Chemistry, Industrial Sciences, or related field
- 3-5 years of experience in a GxP related field
- Experience in Pharmaceutical, Biologics, Cell/Gene Therapy Industry
- Validation experience not required, but 1+ year of experience in Commissioning/Qualification/Validation is preferred
Working Conditions:
Position requires qualified individuals to see, hear and speak (verbally and audibly). Required to ascend and descend stairs; sit, stand, lift, bend, stoop, crawl and kneel. The employee must also use hands to finger, handle or feel. Occasionally reaching with hands and arms, climbing or balancing are required. May be asked to drive or travel by car, air, or other transportation for business purposes.
May be required to lift and carry up to 20 pounds.
Must be able to function effectively with noise in a lab environment. Natural and regular stressors occur on the job.
Must be able to work unimpaired.
Disclaimer:
Please note: DiscGenics reserves the right to change, modify, suspend, interpret, or cancel in whole, or in part, any of the duties outlined above, at any time, and without advance notice to the employee.
