Computer Systems Validation Engineer III
Resilience | |
paid holidays, tuition reimbursement, flex time, 401(k) | |
United States, Florida, Alachua | |
May 01, 2024 | |
A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit Position Summary & Role Resilience Government Services (RGS) located in Alachua, FL is seeking an experienced Senior Computerized Systems Validation (CSV) Engineer to oversee and perform computer systems validation activities sitewide, ensuring that business processes required to operate are qualified and maintained in a validated state according to regulations, guidelines, company directives and procedures (as applicable to a GMP Biomanufacturing facility). The successful candidate will have advanced knowledge and experience developing and leading CSV and Life-cycle management activities to support GxP conforming systems, facilities, manufacturing and laboratory systems. The Senior CSV Engineer understands industry-wide and Regulatory expectations for computer system validation and works with members of IT, QA, and Site organizations to ensure that Computerized System Validation (CSV) packages are consistent with validation plans and standard operating procedures and utilizes industry experience to identify continuous improvement opportunities for CSV practices. This position reports to the Manager of the Validations team and will work very closely with Digital Quality, Digital and Engineering functions. Job Responsibilities
Minimum Qualifications
Preferred Qualifications:
Role/Site Specific Requirements This role is primarily a non-Sedentary role. This can include climbing, kneeling, repetitive motion, temperature changes, and exerting up to 100 pounds of force to move objects. Visual acuity such as: working with data & figures, viewing computer terminal, extensive reading, operating machinery, operating motor vehicles, general observations of facilities, etc. Participation in an occupational health program (which can include medical assessment, surveillance, vaccination, and testing) Use of personal protective equipment (which can include respirators, Personal Air Purifying Respirators [PAPR], gowns, gloves, face protection, other barrier equipment, etc.) Exposure to the following:
Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process. Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $80,000.00 - $117,500.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters. |