Validation activities can include equipment, instrument, cleaning, computer, and process validation. The job includes writing and coordinating protocols, reports, compiling data/attachments into comprehensive validation packages. The position may participate in the design, build activities, equipment procurement, optimization and troubleshooting of equipment and processes, hiring and development of staff.
Responsibilities
1.1 Lead the development of procedures, specifications, validation master plans, and other validation and engineering-related documentation.
1.2 Lead all validation activities with a hands-on approach, including equipment, instrument, cleaning, computer, and process validation.
1.3 Work on multiple validation projects simultaneously and coordinate test work.
1.4 Lead FATs, SATs, IQ/OQ/PQs of facilities, utilities, and equipment in collaboration with the Engineering and Quality teams
1.5 Author or review protocols for manufacturing, utilities, lab equipment, and processes.
1.6 Oversee validation execution work according to protocol instructions and procedures.
1.7 Plan, coordinate and track the progress of validation projects.
1.8 Compile validation packages and assure all required documentation is accurate and complete
1.9 Identify and champion process improvement projects and ensure equipment and systems remain in a qualified state.
1.10 Lead investigations related to validation deviations and assure thoroughness of the investigation, documentation and closure.
1.11 Work with other groups to validate drug product manufacturing processes.
1.12 Write, review and approve technical documents and reports such as protocols, SOPs, filing documentation and other cGMP documents.
1.13 Maintain strict deadlines to minimize impact to production and maximize equipment/process efficiency.
1.14 Participate in equipment/process design, specification of use requirements.
1.15 Hire and develop validation staff.
Qualifications
2.1 BS or above in Biology, Chemistry, Engineering or related science or equivalent experience
2.2 7 years of validation experience in a cGMP manufacturing environment.
2.3 Minimum of 5 years of previous leadership experience in a related field.
2.4 Excellent working knowledge of cGMPs and regulatory requirements is preferred
2.5 Exceptional interpersonal, organizational and computer skills.
2.6 Ability to change priorities in response to company demands while continuing to deliver results
2.7 Demonstrated ability to work/collaborate within teams while interfacing with both internal and external colleagues
2.8 Strong knowledge of calibration methodology, equipment, and instruments
2.9 Strong initiative and drive to complete ambitious tasks and learn new technologies related to CAR T products.
2.10 Ability and desire to work in a fast-paced environment, manage large projects.
2.11 Excellence in oral and written communication skills.
2.12 Independently motivated with strong problem-solving ability.
2.13 Experience in hosting FDA, EMA, and other regulatory agencies’ inspections
2.14 Team building and managing skills including recruiting, coaching, counseling, and disciplining.
Equal Employment Opportunity Policy
CARsgen Therapeutics Corporation provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.