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JOB DETAILS

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 visitwww.resilience.com

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

• Conception, planning and performing of Computer Systems Validation (CSV) in the regulated environment.
• Advisory and support of application owners to build and maintain GxP conforming systems and ensure compliance with applicable regulations and industry standards.
• Implementation of qualification/validation requirements for new and existing computer systems.
• Development and implementation of CSV procedures that adhere to Data Integrity requirements as defined in applicable regulation for Raw-Data-Handling systems and solutions.
• Oversee and perform computer system validation activities and ensures the approach and execution aligns to applicable regulations, GAMP 5, and RGS’s directives and procedures.
• Develop/enhance and implement Computer Systems Validation documentation such as VPs, Test Scripts, Assessments, Reports, SOPs, Policies.
• Support the implementation and adoption of the global CSV program and remediation.
• Support data integrity implementation and remediation for systems within CSV program.
• Participate in audits and continuous improvement efforts related to CSV program.
• Support RGS to achieve all CSV site and corporate goals.
• Managing of CSV projects.

Minimum Qualifications

• Extensive relevant CSV experience with Manufacturing and Plant automation systems supporting GMP manufacturing.
• Direct experience implementing CSV activities to support GxP systems.
• Extensive experience with FDA and cGMP regulations and documentation practices.
• Experience with GAMP 5, 21 CFR Part 11, and Annex 11 along with computer system validation methodologies.
• Experience managing direct projects and external vendors.
• Experience upgrading legacy systems, and installing, integrating, optimizing process systems, and qualifying new systems.
• Strong project leadership, technical, communication, and organization skills in a cross-functional teamwork environment.
• Ability to work both independently and cross-functionally with IT, QA, and Site organizations in a dynamic, ever-changing environment.
• Understanding of modern and risk-based validation executions.

Preferred Qualifications:

• A minimum of 7 years relevant CSV experience
• Bachelor’s Degree (BS) in Engineering/Sciences or equivalent with 3+ years of relevant experience.
• MS degree in engineering, or a related STEM field with 2+ years of relevant experience
• Experience performing and leading CSV responsibilities at well-established Biomanufacturing or Pharmaceutical facilities.
• Experience with equipment/process design, procurement, installation, and qualification, DI assessment, CSV, and DI gap mitigation strategies.
• Strong Computer system/process/control aptitude with an understanding of critical systems.

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:

• Moving mechanical parts, electrical current, working on high places, exposure to high heat or exposure to chemicals.
• Handling, managing, disposing hazardous and non-hazardous waste (which can include: chemicals, universal and e-wastes, oil, aqueous wastewater, etc.), inclusive of exposure to bloodborne pathogens
• Working in BSL-2/3 laboratories & production rooms, waste holding areas, or other facilities where biological hazards and hazardous chemicals may be stored or handled.
• Conditions that affect the respiratory system or the skin: fumes, odors, dust, mists, gases, or poor ventilation.
• Close quarters, narrow passageways, crawl spaces, shafts, manholes, small enclosed rooms, small sewage and line pipes.
• Use of personal protective equipment (which can include respirators, Personal Air Purifying Respirators (PAPR), gowns, gloves, face protection, other barrier equipment, etc.
• Noise exposure of over 85 decibels (enough noise to shout to be heard above ambient noise level).

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.

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