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Job Description:

Summary:
EQUINOX IT SOLUTIONS LLC seeks an experienced Validation Engineer to implement and execute the validation program at its in-house cGMP Cell and Gene Therapy Manufacturing facility, the Manufacturing Center for Advanced Therapies (MCAT). This is a unique opportunity to shape the ongoing Validation strategy at a rapidly growing biotechnology company focused on the development of highly novel genome-edited therapeutics for immuno-oncology and genetic disease, that currently has 195 employees and a highly people- and patient-centric, science-driven culture. The ideal candidate will have broad experience in the commissioning, qualification, and validation of a broad range of biopharmaceutical equipment and processes, including managing re-qualification schedules.
Essential Duties and Responsibilities:
As a Validation Engineer, you will be responsible for oversight of validation and qualification of equipment, utilities, facilities, and software programs that are used in the CGMP environment
• You will develop, review, and/or approve qualification and validation (IQ, OQ, PQ, PV) documentation and ensure they are written in accordance with the FDA, EMA, and industry standards.
• You will oversee and work with Manufacturing, Quality Control, Quality Assurance, Facilities, IT, and Materials Management in the implementation of validation activities and to design and draft validation and qualification protocols.
• As a Validation Engineer, you will take part in the establishment, implementation, follow-up, and maintenance of continuous validation plans and assist in the development of Facility, Equipment, and Utility maintenance plans that address each type of equipment or system on a scheduled basis.
Qualifications:
Bachelor's Degree in a scientific or engineering discipline required, an advanced degree is preferred
• 5+ years of experience in a pharmaceutical environment working with the validation and qualification of equipment, utilities, facilities, and IT systems.
• Highly knowledgeable in the functional operation and validation of laboratory and bioprocessing equipment and processes, including FAT and SAT execution.
• Strong background in cGMP environments
• Ability to learn how novel equipment functions and then design appropriate risk-based validation/qualification protocols
• Familiarity working across a broad range of IT systems including LIMS, MES, requirements traceability packages, and SaaS platforms
• Ability to work effectively within a highly collaborative environment, exhibiting deep subject matter expertise and leadership skills while enjoying a high degree of autonomy
• Experience in a start-up environment is preferred