Validation Engineer III
hcfa.fa.us2.oraclecloud.com/KashivUSCareers · Chicago, Illinois, United States
The Validation Engineer is a regular employee in a full-time exempt position at Kashiv BioSciences, LLC, in Chicago, IL. This position will report directly to the Validation Management and will support various functional areas within Kashiv.
- Write and Develop Equipment/Facility/Utility and Instrument Qualification protocols (first in kind) and Validation/Qualification Policies.
- Initiate an own Change Controls; provide validation assessments and remediation plans as required by the system/equipment/components.
- Develop Commissioning and Qualification Plans.
- Develop URS, FS, DQ documents and qualification protocols (IQ/OQ/PQ) to ensure compliance with 21CFR Part 210 and 211 and adherence to ICH Q7.
- Participate in Risk-Based evaluations, utilize Risk Assessment Methods/tools, and provide technical input during FMEA processes.
- Lead discussions and provide guidance to personnel during risk assessments.
- Assure adherence to Q9 “Quality Risk Management”.
- Assure Compliance with FDA and EU Regulations.
- Evaluate, document, and develop investigations attributed to qualifications failures.
- Author Summary Reports, events, and applicable protocol amendments.
- Execute and/or provide support during protocol executions.
- Assure all the qualification items are tracked and successfully completed.
- Perform GAP analysis and provide recommendations for existing qualifications.
- Ability to work in a fast pace, team-oriented environment.
- Technical problem-solving ability, manage multiple priorities, provide logical and analytical reasoning, technical writing ability, and self-training.
- Potential to manage engineering projects from design through qualification, depending on candidates experience and skill set.
- Candidate must adapt the work schedules to perform required qualification activities. This may require overnight and/or weekends.
- Complies with all company policies and standards
- Performs other functions as required or assigned
Education:
BS or MS Degree in related Engineering field.
Experience:
At Least 4 Years of experience in automated systems, project management is a plus.
At least 2 years’ experience commissioning, validation and qualification of Equipment/Facilities/Utilities and Processes using Risk Based approach and leverage strategies.
Special Skills:
- Able to work in a fast-paced environment.
- Technical problem solving, handle multiple priorities, perform well under stressful situations, think fast, logical and mathematical reasoning, technical reading interpretation and self-training.
- The candidate must adapt the work schedules to perform required qualification activities. This position may require overtime, overnight or on weekends. Occasional travel for equipment FATs.
Work Environment & Physical Demands:
- Work in machinery rooms, clean rooms, and laboratories.
- Work at a desk doing computer work (reading, editing, writing document) is also required.
- Must be able to move around the facility to reach various equipment.
- Must be able to lift at least 25 lbs.
Travel:
- Occasional trips for equipment FATs at vendor sites, lasting up to 2 weeks at a time. Potential for international travel. No regularly scheduled travel.
The salary range for this position ranges from $103,000 - $130,000 per year. In addition, Kashiv BioSciences, LLC., offers a short-term incentive opportunity, such as a bonus or performance-based award as well as a long-term incentive award, such as restricted stock units, with this position within the first 12 months. Kashiv BioSciences, LLC., ranges reflect the Company’s good faith estimate of what Kashiv BioSciences, LLC., reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.
At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.