Validation Engineer job CHALFONT Pennsylvania
Validation Engineer  job CHALFONT Pennsylvania
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Validation Engineer Job

Employer Name: Harita LLC SpiderID: 9663899
Location: CHALFONT, Pennsylvania Date Posted: 6/23/2020
Wage: Category: Medical/Health
Job Code:

Job Description:
Validation Engineer needed to perform the following duties :

∑ Plan and manage equipment qualification including execution support for IQ, OQ, PQ and Requalification for units such as Autoclaves, Filling Lines, Depyrogenator etc.

∑ Communicate with cross-functional teams to ensure compliance with applicable industry standards of all production equipment.

∑ Plan and manage project schedules with respect to production needs and meet project deliverables.

∑ Development of typical Qualification deliverables for MHRA compliant sterilizer cycles, including but not limited to Requirements Documents, Test Protocols for Performance Qualification (PQ) and Summary Reports.

∑ Troubleshoot utility, process and manufacturing equipment for any issues and failures.

∑ Plan and Maintain change control for all validated processing equipment and investigate out of specifications/deviations related to equipment failures as required.

∑ Prepare and execute equipment/systems for qualification studies according to approved protocols and SOPs

∑ Perform Root Cause Analysis. Identify the issue and define optimistic solution.

∑ Critical Technical Production Issues Resolution: Root Cause Analysis, Collaboration with various technical teams, Strong Understanding of business flows and integrated up stream & downstream applications.

∑ Analyze the results of testing and determine the acceptability of results against pre-determined criteria.

∑ Design process flow diagram and Fish Bone diagram to generate and organize desired effect.

∑ Designing or adopting, validating, and implementing sterilization processes, taking into consideration product fitness for use, product/packaging functionality, and process compatibility

∑ Maintain the site Validation Protocols current with all corporate, cGMP, ISPE, ICH, PDA, Current Industry Standards, The Code of Federal Regulations and FDA initiatives.

∑ Maintain current knowledge in the areas of compliance, validation and other regulatory issues that may impact the business.

Bachelorís Degree required in Mechanical Engineering or Biomechanical Engineering or Biomedical Engineering

Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required: Bachelors
Overnight Travel:
Vacation Time:

Contact Information:
Contact Name: Harita LLC Company Type: Employer
Company: Harita LLC
State: Pennsylvania

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