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SHINE Technologies · 3 months ago

Validation Engineering Supervisor

Janesville, WI

Full-time

Onsite

Mid, Senior Level

$100K/yr - $115K/yr

3+ years exp

SHINE Technologies is seeking a Validation Engineering Supervisor responsible for developing validation strategies to ensure compliance with regulatory standards. The role involves supervising validation initiatives, managing qualification projects, and collaborating with cross-functional teams to enhance validation processes.

BiotechnologyEnergyHealth CareManufacturingMedicalMedical DevicePharmaceutical

Responsibilities

Developing and Implementing Validation Strategies:

Create and maintain validation program ensuring it aligns with a lifecycle approach and meets regulatory requirements and project goals

Manage Master Validation Plan, through the review and implementation of all necessary standard operating procedures for plant processes, equipment installation and operational qualification (IQ/OQ), performance qualification (PQ), requalification and revalidation of critical systems and utilities

Review, plan, schedule and implement new and existing validation projects including facility systems, manufacturing equipment and processes, analytical instrumentation, and cleaning processes

Recommend validation and qualification approaches, strategies, priorities and required resources during project planning and development phases to meet FDA and EMA regulatory requirements

Responsible for managing Qualification/Validation initiatives/projects and personnel ensuring adherence to timelines and deliverables

Provide status and progress reports for validation/qualification activities or projects for the Management Review Meetings

Develop a computerized systems validation approach that meets the FDA and EMA guidelines

Support the drafting of URS documents for major equipment purchases and support the onboarding of equipment into the cGMP system

Develop/draft various validation templates incorporating the lifecycle strategy

Provide guidance on development and preparation of protocols for process qualification, cleaning validation, equipment commissioning and qualification (including but not limited to FAT/SAT/IOQ and PQ) as well as CSV (Computer Software Validation) documentation to ensure data integrity requirements are met

May review and analyze analytical and physical data generated from executed validation/qualification activities

Review/draft validation/qualification final reports that present, summarize and offer conclusions on the validity of the processes based on objective evidence, obtain necessary approvals

Prepare documentation and provide support for regulatory/compliance inspections

Support internal and external audits, regulatory inspections, and remediation efforts related to equipment and software validation and compliance

Review and approve periodic reviews of system(s) validation. Ensure appropriate plans are determined for gaps identified during periodic reviews

Mentor and Train Team Members on Validation Processes and Requirements:

Managing validation activities and ensuring efficient execution of validation tasks

Support training activities related to qualification and validation activities through assignments in ACE (electronic Quality Management System) and on the job training (OJT)

Risk Management:

Work with Development, Manufacturing and Quality personnel to generate risk management deliverables for new projects, processes, and equipment (Preliminary Hazard Analysis Assessments, Criticality Assessments, System Impact Assessments, Risk Management Reports, Failure Mode and Effects Analysis)

Ensure risk management is incorporated into the validation program

Responsible for keeping the qualification/validation of the facility, equipment and processes current

Reviews proposed changes for impact to system qualification and validation. Identifies and completes requalification activities to support change completion

Collaboration:

Working closely with cross-functional teams (e.g., R&D, Quality, Engineering, IT) to ensure alignment of validation activities with other project phases and deliverables

Collaborates with cross-functional teams to meet project objectives, timelines, including scheduling, qualification testing, and deviation resolution

Continuous Improvement:

Identifying opportunities for improvement in validation processes and procedures and implementing corrective actions

Qualification

Validation strategiesCGMP environmentsRegulatory complianceData analysisProject managementTeam supervisionRisk managementContinuous improvementCommunication skills