Job Listing Description

Validation Engineer

Description:
PDS Tech, Inc. is seeking a Validation Engineer in Miami, FL.

How will you make an impact?



  • The Validation Engineer participates as an active member of a dynamic team with high involvement and engagement in cell culture media manufacturing operations.
  • Supports the Validation and Quality Control programs within the Miami, Florida site 


What will you do?             



  • The Validation Engineer participates as an active member of a dynamic team with high involvement and engagement in cell culture media manufacturing operations. Supports the Validation and Quality Control programs within the Miami, Florida site.
  • Author and execute protocols in support of new equipment, instrumentation, Computer Systems, and analytical method validation and method transfer.  
  • Complete validation reports and resolution of deviations.
  • Work closely with business stakeholders technical support groups and QA to thoroughly investigate validation discrepancies and drive best practice for system validation.
  • Provide direction to vendors in the qualification of equipment.
  • Effectively liaison with representatives from originating / sending sites, R&D, Quality Control, etc. to ensure design and readiness for laboratory test method validations, verifications, and transfers to support NPI / transfer projects.
  • Provide support in the area of troubleshooting of new / existing equipment and test methods.
  • Support change management system and assess for validation impact.  Execute validation deliverables as defined by the Quality Management System.
  • Assure compliance to appropriate regulatory requirements.  Initiate quality records when not in compliance and inform Quality of noncompliance and proposed corrective activities.
  • Assure validation support structure and document handling systems are maintained.
  • Ability to function efficiently and independently in a fast paced, changing environment.
  • Make effective decisions relative to position requirements.
  • Work with functional teams to achieve operational goals.
  • Communicate issues and concerns to management.

How will you get here?



Education



  • Bachelors Degree in Science or Engineering is required.


Experience



  • Minimum of 4 years of validation experience in Pharmaceutical / Biotechnology industry.


Knowledge, Skills, Abilities



  • Hands-on experience in Quality Control laboratory instrumentation and equipment qualification. 
  • Experienced in developing IOQ, CSV, method validation and method transfer plans and protocols.
  • Thorough knowledge of quality management systems and validation principles for equipment, laboratory test methodologies, regulatory agency expectations, and industry trends.
  • Knowledge and experience in engineering, chemistry, microbiology, and other sciences to effectively meet the responsibilities of the position.
  • Possesses technical and analytical skills to be able to lead root cause investigations in a timely and effective manner.
  • Strong technical writing, effective verbal communication, and interpersonal skills.
  • Ability to prioritize and perform multiple tasks, with minimal supervision required.
  • Ability to work in teams to obtain results, self-motivated, and ability to effectively manage conflict.
  • Working competency of Microsoft Word, Excel, Power Point, Project, and statistical programs.


Working Conditions



  • Job Complexity:  Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.  Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.  Internal and external contacts often pertain to company plans and objectives.
  • Supervision:  No direct reports.  Will be expected to determine methods and procedures on new assignments and may provide guidance to other personnel. 
  • Exposure to industrial machinery, sharp and moving parts, electrical and other energy sources.
  • Personal Protective Equipment (PPE) required including but not limited to lab coats, hair / beard covers, shoe covers, gloves, ear protection, eye protection and specialized cleanroom suits and head coverings as required.
  • Exposure to fumes and chemicals such as raw materials, cleaners, etc.
  • Infrequent exposure to high frequency noise.
  • Ability to lift up to 25 pounds repetitively. 
  • Must be flexible to meet requirements of qualification work schedules.

 
Job Number: 2110130496
Job Location: Miami, FL
Duration: 4 months
Input Date: 11/22/2021
Firm Name: PDS TECHNICAL SERVICES
Attention: Clyde Callwood
Address: 3922 COCONUT PALM DR STE 100
City, State: TAMPA, FL 33601
800 Phone: 866/224-2745
Email: southeastjobs@pdstech.com
Website: https://pdsjobs.force.com/candidates/job_detail?id=a1i1T000003Pk6bQAC&URLSource=cjhunter

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