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Company

Original Job Post

BioSpace · 3 days ago

Validation Engineer IV

West Chester, OH

Full-time

Onsite

Senior Level

$95K/yr - $136K/yr

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Comp. & Benefits

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Responsibilities

Author, Review and approve documentation needed for qualification of equipment and processes.

Serve as an SME to the entire Validation Process: Commissioning, IOQ, PQ, PPQ, CPV

Be a Validation Leader in the functional area assigned, Aseptic Activities, Packaging or Inspection

Prepare documentation of activities, actions, and/or results.

Monitor records to ensure compliance with regulatory requirements.

Ensure proper documentation practices during job activities.

Answer compliance and process questions from others.

Communicate policies and procedures to employees.

Gather, organize, and communicate operational information to others.

Communicate priorities and progress to team on a continuing basis.

Guide others on SOPs (Standard Operating Procedures), control documents, and/or other work instructions.

Initiate appropriate action when process deviations occur.

Interact with other departments to implement corrective/preventative actions.

Participate in cross-functional teams to meet strategic goals.

Review and approve change controls, and document revisions.

Attend team meetings to discuss progress, initiatives, and/or other matters.

Read, understand, and comply with cGMP (Good Manufacturing Practices) and SOPs (Standard Operating Procedures), including general safety, lock outs and so on.

Read and interpret diagrams, drawings, and other schematics.

Facilitate the execution of validation protocols for processes, equipment.

Consult cross-functionally as an SME (Subject Matter Expert) on systems and/or processes within a functional area.

Coordinate qualification activities.

Participate in troubleshooting activities.

Lead process improvement activities and teams to meet strategic goals.

Facilitate communication between management and non-management.

Investigate deviations.

Close out deviations, CAPAs, and/or pAFCAs as needed.

Identify temporary and permanent fixes to address issues.

Interact with regulatory agency personnel during audits and inspections.

Write, review, and revise SOPs (Standard Operating Procedures) and/or work instructions for cGMP (Good Manufacturing Practices) manufacturing of commercial product.

Read technical publications and manuals and write associated procedures.

Approve new and updated SOPs.

Recommend and initiate activities to ensure area and equipment is maintained in a state of compliance.

Occasionally Provide "off shift" support (for example: night shift support if you normally work day shift).

Assist process engineering and managers with improvement projects.

Help Project Managers lead the area of responsibility into timely executions including a risk based validation approach

Assist in the training and uplift General Validation knowledge within the group through knowledge sharing.

Recommend compliance resolutions to management.

Review and approve requirements, specifications, drawings, coding procedures, and guidelines.

Qualification

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ValidationProcess EngineeringManufacturingInterpretation of DrawingsSafety GuidelinesReport WritingTroubleshootingProblem-SolvingAnalyticalCommunicationTime ManagementLeadershipCGMPAnalytical MethodologyInstrumentationChemical Process SafetyQuality Assurance