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Validation Specialist

  1. North America, East Coast
North Carolina
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
36354
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Validation Specialist - Life Sciences - 24-month contract - North Carolina

Our client, a global pharmaceutical manufacturing organization are looking for a talented Validation Specialist to join their expanding team. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility in the United States.

Responsibilities:
  • Provide validation and technical support through the preparation, execution, data analysis and report writing for IV, OV and PV protocols.
  • Ownership of Change Requests (CR’s) related to project validation responsibilities.
  • Perform compliance and technical reviews/approvals of protocols and protocol data.
  • Author Implementation Plans (IMPL), validation plans (VPL’s) and other key validation documentation.
  • Author and execute assigned IV, OV and PV protocols for direct impact systems / processes per approved timeframes. Requires limited guidance and direction to complete these goals and needs no coaching on technical competencies for goal obtainment.
  • Ensure compliance of validation protocols executed are aligned with local, corporate and regulatory regulations.
  • Lead validation failure investigations and non-conformities utilizing root cause analysis techniques.
  • Create and modify existing validation procedures and configuration item lists (CIL’s) as required.
  • Experience with IT systems such as PAS-X, SAP and Aveva PI and Computerized Equipment such as Autoclaves, Packaging Assembly, Filling, Cart Washer, Utensil Washer, CIP/SIP, Formulation, Etc.
  • Participate in FAT, SAT commissioning efforts for computerized equipment, automation systems and processes and successfully transition into the ownership role for validation efforts related to the equipment.
  • Identify process improvements before equipment, systems or processes are placed under change control during validation.
  • Assist with development and improvement of system user requirements.
  • Coordinate and communicate with It and automation team to ensure validation efforts are met.

Skills & Responsibilities: 
  • Experienced with regulatory requirements and industry standards for pharmaceutical and/or medical device manufacture, such as 21CFR Part 11, GAMP5, ISO, electronic records retention, configuration items list, FDA and ICH guidance documents.
  • Experience in pharmaceutical manufacturing preferred. Knowledgeable in GMP concepts.
  • Knowledge of standard operating procedures with attention to high-level concepts.
  • Ability to manage multiple tasks/deadlines and prioritize properly based on process needs.
  • Validation or quality related discipline experience in pharmaceutical environment.
  • Demonstrated experience using root-cause analysis techniques to solve problems.
  • Ability to read, write and understand complicated product documentation.
  • Demonstrated leadership and project management skills: two-way communication skills with customers (internal/external), project team and management; interpersonal and team building skills; achievement of project timelines and customer requirements.
  • Ability to write technical documentation based on equipment manuals.
  • Demonstrated strong skills in change management.

Interested in this role? Apply today!


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