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Company

Original Job Post

BioSpace · 2 days ago

Validation Engineer II

Alachua, FL

Full-time

Onsite

Entry, Mid Level

$70K/yr - $96K/yr

2+ years exp

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Comp. & Benefits

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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.

Qualification

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Validation ProcessRisk-Based ApproachesValidation DocumentsQuality SystemsBiomanufacturing OperationsUpstream OperationsDownstream OperationsDrug Substance ProcessesDrug Product ProcessesGxP utility systemsQC Analytical InstrumentsHPLCUPLCLight Scattering InstrumentMicroscopesLaminar FlowEndotoxinGCVi-CellIncubatorFreezerRefrigeratorSCADAMODALIMSBio Command Batch Control PlusHistorianRockwell Automation FactoryTalkJohnson Controls MetasysRees Centron Presidio

Required

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.

Preferred

BS degree in a scientific or engineering discipline preferred.

2+ years of hands-on experience with 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.