Browse by job sector

Lab Validation Engineer

  1. North America, United States
County Mayo
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
35640

This vacancy has now expired

Lab Validation Engineer - Pharmaceuticals - County Mayo - 6 Months

The role of the Validation Engineer is the ensure customer satisfaction is delivered with each revalidation, validation and project work. All validation activity is to be performed in line with Global Standards, FDA, HPRA and other MPH regulatory requirements. This schedule compliance will be achieved by actively engaging with senior management and the impacted BU’s and ensuring all projects can be managed and prioritised as required.


Responsibilities:
  • Over-see, coordinate, guide and implement the site validation master under prospective, concurrent, and retrospective validation studies in a timely manner, with the relevant engineers. To ensure that all validation requirements are met for any new process, equipment or change to existing process or equipment.
  • To actively work on validation projects, being the departmental point person and completing all associated project documentation in line with current corporate and regulatory expectations. To ensure that all documentation pertaining to each validation study under his / her responsibility is compiled, authorised and filed in a timely and organises fashion. To work with the other validation engineers to achieve compliance by coordinating each validation project assigned. The process involves the review and approval of validation documentation and co-ordination of the validation work
  • Participate in risk assessment process for all business units & participate in design review process for all business units.
  • Tracking and generation of weekly metrics (GTW QMS, EHS, Compliance Wire etc.)
  • To facilitate the PQR review process / Regulatory Review Process and Laboratory Equipment Review Process as per the current rota’s.
  • Keep abreast of current and changing regulatory guidance for the relevant areas of validation that applies. Provide support for audit preparation, direct audit interaction and involvement in audit response.

Qualifications:
  • Bachelor’s degree required in science based or engineering discipline
  • Experience in Pharmaceutical company
  • Excellent project management skills
  • Proficient in use of Microsoft Office suite of programs
  • Critical thinking and problem-solving skills
  • Ability to articulate clearly when dealing with internal and external bodies.
  • Excellent conflict handling skills
  • Expertise in the relevant subject matter areas – example Equipment, Facility, Aseptics, Process, CPV, CSV, Cleaning
 
If this role is of interest to you, please apply now! 

#LI-JS4
Save as a job alert
List #1

Similar Jobs

Packaging CQV

Salary

Competitive

Location

Denmark

Salary

Competitive

Sector

Commissioning, Qualification and Validation

Job type

Contract

Location

Denmark

Description

Packaging CQV - Denmark - 6-12 Months Contract  Our client, a global CDMO in pharmaceutical manufacturing, is recruiting for a Packaging CQV to join their new and exciting large-scale CAPEX

Reference

36927

Expiry Date

01/01/0001

Abigail Stier

Author

Abigail Stier
Abigail Stier

Author

Abigail Stier
Read more
Read more
Cleaning Validation SME

Salary

Competitive

Location

Brussels

Salary

Competitive

Sector

Commissioning, Qualification and Validation

Job type

Contract

Location

Belgium

Brussels

Description

Cleaning Validation SME - Brussels, Belgium - 3/6 Months Contract We are looking for an experienced Cleaning Validation SME for a fantastic 3-6 months contract based in Brussels. You will be

Reference

36903

Expiry Date

01/01/0001

Chris Bland

Author

Chris Bland
Chris Bland

Author

Chris Bland
Read more
Read more
Validation Engineer

Salary

Competitive

Location

Carlow

Salary

Competitive

Sector

Commissioning, Qualification and Validation

Job type

Contract

Location

Ireland

West

Description

Validation Engineer - Ireland - 11 Months Contract Do you want to be involved with exciting pharmaceutical projects? When it comes to the development and production of veterinary vaccines, our

Reference

36688

Expiry Date

01/01/0001

Christopher Hutchinson

Author

Christopher Hutchinson
Christopher Hutchinson

Author

Christopher Hutchinson
Read more
Read more

Insights

Day In the Life of a Commissioning Engineer Jobs

Day in the Life of a Commissioning Engineer

Read more

11/03/2024

North Carolina

Living and working in North Carolina
Read more

03/26/2024

Living and Working in Michigan

Living and Working in Michigan
Read more

10/25/2023

VIEW ALL

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.

Send your CV
Upload your CV