Skip to main content

Validation Specialist

  1. North America, East Coast
North Carolina
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
36354
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!


#LI-EG1


Save as a job alert
List #1

Similar Jobs

Validation Lead

Salary

Competitive

Location

Bielefeld

Salary

Competitive

Sector

Commissioning, Qualification and Validation

Job type

Contract

Location

Germany

Central Germany

Description

Validation Lead - North Rhine-Westphalia, Norway - 6-12 Months Contract This innovative organisation is a global leader in the development and manufacturing of high-quality sterile injectable

Reference

36754

Expiry Date

01/01/0001

Peter Hallam

Author

Peter Hallam
Read more
CQV DSM Engineer

Salary

Competitive

Location

North Carolina

Salary

Competitive

Sector

Commissioning, Qualification and Validation

Job type

Contract

Location

North America

East Coast

Description

CQV DSM Engineer - Life Sciences - 6-month contract role - North Carolina  Our client, a global pharmaceutical manufacturing organization are looking for a talented CQV DSM Engineer to join their

Reference

36636MC

Expiry Date

01/01/0001

Mark Chaumeton Read more
Senior Validation Engineer

Salary

Competitive

Location

Brussels

Salary

Competitive

Sector

Commissioning, Qualification and Validation

Job type

Contract

Location

Belgium

Brussels

Description

Senior Validation Engineer  - Belgium - 9 Months Contract We are looking for an experienced Senior Validation Engineer for a fantastic 9 month contract based in belgium. You will be working

Reference

36734

Expiry Date

01/01/0001

Chris Bland

Author

Chris Bland
Chris Bland

Author

Chris Bland
Read more

Send us your CV

Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.