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Validation Engineer II

National Resilience

National Resilience

Other Engineering
Alachua, FL, USA
Posted on Wednesday, May 22, 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 www.resilience.com

Position Summary & Role

Reporting to the Validation Manager, the Validation Engineer II will lead Commissioning, Qualification and Validation (CQV) activities supporting multiple areas including FUSE, QC Analytical Instruments, Systems, Equipment and Computer System Validation processes for Ology Bioservices. This position will primarily support creation and execution of periodic reviews, re-qualifications, and re-validations.

This position closely works with Engineering & Technical Services, Quality Engineering, Operations, and Quality Control team members to deliver and support the CQV Lifecycle processes of FUSE, QC Analytical Instruments, and Computer Systems.

Job Responsibilities

  • Lead periodic reviews, re-qualifications, and re-validations for FUSE (Facilities, Utilities, Systems and Equipment), QC Analytical Instruments, or any other required areas.
  • Support/lead CQV Commissioning, Qualification and Validation effort for multiple areas of Ology Bioservices equipment and computer systems.
  • Demonstrate working knowledge of FDA regulations, USP 1058, and other industry standards.
  • Maintain expertise in current and emerging CGMP requirements and quality trends (e.g., GAMP5 and 21 CFR Part 11, 210, 211, 820).
  • Developing and managing GxP system lifecycle documentation, including User Requirements Specifications, System Impact Assessment, Component Criticality Assessments, Qualification Protocols (IQ/OQ/PQ), Traceability Matrix, and Validation Summary Reports
  • Managing and coordinate all aspects of the FUSE, Analytical Instruments, Systems, Equipment and Computer Systems Validation activities including project planning, developing validation strategies, and document development.
  • Working with Laboratory Systems (LIMS, MODA, SoftMax, Minitab) and Laboratory Equipment (HPLC, UPLC, Light Scattering Instrument, Microscopes, Laminar Flow, Endotoxin, GC, Vi-Cell, Capillary electrophoresis, Incubator, Freezer, Refrigerator).
  • Working with manufacturing process equipment such as Single-Use Bioreactor (SUB) and Fermenters utilizing bioprocess supervisory software BioCommand Batch Control Plus.
  • Develop, design, program and sustain equipment systems commissioning, qualifications, and validation. Leverage existing documentation, using good manufacturing practices and GEPs (Good Engineering Practices)
  • Support vendor procurement process with both FAT Factory Acceptance Test authoring, leadership and execution followed by SAT Site Acceptance Testing.
  • Establish critical parameters, plan, design, and implement validation projects and protocols (Write, execute, and review complex protocols).
  • Support vendor CQV activities (Vendor Approval, schedule, escort)
  • Review vendor documentation such as protocols, project submittals, drawings, etc.
  • Maintain the validated state where applicable (Lifecycle).
  • Purchase supplies and equipment for validation activities
  • Participate / initiate Engineering Change Management (ECM)
  • Participate Quality Management System / Change Control, CAPA (QMS – Veeva)
  • Follow applicable standard operating procedures while working in validated systems.
  • Assembling or reviewing documentation for commissioning such as ETOP (Engineering Turn Over Package) for various systems such as FUSE, QC Analytical Instruments, Systems, Equipment, etc.
  • Continuous Improvement of procedures, protocols, forms (life cycle process).
  • Follow applicable standard operating procedures while working in validated systems.

*All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role.

Minimum Qualifications

  • Understanding of qualification or validation process in regulated industry such as Biopharma and the ability to develop new more robust risk-based qualification approaches for risk reduction.
  • Hands-on experience developing and executing validation documents including IQ, OQ, IOQ, PQ, Summary reports, MVP, Engineering studies, Requalification protocols, Deviations and CAPAs.
  • Familiarity with quality systems and validation process in regulated industries such as biotechnology, medical device, or pharmaceutical manufacturing.
  • Sound understanding of biomanufacturing unit operations, including upstream and downstream operations and Drug Substance (DS) and Drug Product (DP) processes will be helpful.

Desired Qualifications

  • BS degree in a scientific or engineering discipline preferred.
  • 2+ years of hands-on experience with the following various industry systems such as GxP utility systems (USP Water, WFI, Clean Steam, CCA, Process Gases, HVAC, etc.) and QC Analytical Instruments and Equipment: HPLC, UPLC Light Scattering Instrument, Microscopes, Laminar Flow, Endotoxin, GC, Vi-Cell, Incubator, Freezer, Refrigerator.
  • Hands-on experience with various industry computer systems such as SCADA / MODA / LIMS / Bio Command Batch Control Plus, and Historian vendors such as Rockwell Automation FactoryTalk®, Johnson Controls Metasys®, Rees Centron Presidio® and Vaisala Continuous Monitoring systems and CQV equipment such as Kaye Validator, heat / cold block, calibration standards.
  • Hands-on experience with computer system validation.
  • Ability to obtain certification if requested in various ASQ American Society of Quality, PMP Project Management Professional, and ASQ Six Sigma/Lean Sigma Green or Black Belt.
  • Strong initiative and integrity as well as strong written and verbal communication skills.
  • Must demonstrate an ability to investigate automation solutions and troubleshoot complex problems on highly automated equipment to address business needs.
  • Proven ability to successfully work independently and within teams.
  • Must be able to support shift operations at the facility.
  • Proficiency with Microsoft Office Suite.

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 $70,000.00 - $96,250.00 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.