SENIOR VALIDATION ENGINEER
12 Month Rolling Contract
A vacancy exists with my client for a Validation Engineer within the Technical Services Department. The successful candidate will be reporting to the Senior Manager - Capex Portfolio Project Engineering.
The primary tasks of the role include:
To lead all aspects of Validation programs for the company in order to meet appropriate GMP regulatory and validation requirements.
Act as a Subject Matter Expert in area of responsibility.
Provide a visual management system that will display a weekly and monthly output in a tier system.
Report into Senior Manager Capex Portfolio Project Engineering daily.
Develop and improve the process of validating equipment within LEO Pharma along with improving the current SOP's.
Update templates in the paper system so that easy transition will take place when paperless system goes live.
Take an active role in recruiting for the department when LEO is expanding its workforce again.
Take an active role in helping to develop the validation strategy for the site and department with a view to reducing the current processes and streamlining them to greatly improve efficiencies.
Actively set goals for your reports and follow the goals set by Line manager for career progression.
Goals for dept may include - supporting production output xxM units per year.
Set personal and behavioural improvement goals.
Recommendations for the department may include: Template updates and storage solutions, Defining the quality requirements in the validation process so that roles and responsibilities are clearer, Implementation of Good engineering practices C&Q that will overlap with Project management and other departments stage gates and processes & defining periodic reviews.
The ideal candidate will possess the following:
Third level honours qualification in Chemistry / Pharmacy / Biology / Engineering or other appropriate discipline (essential).
Minimum of 3 to 5 years' experience in a quality, production or engineering function in the Pharmaceutical Industry desirable
Excellent communication skills and strategic mind-set
Team oriented Fast acting - including an ability to quickly understand and evaluate complex issues and make decisions based on the analysis
Achieves results while achieving deadlines
Works independently and is self-driven
ROLES AND RESPONSIBILITIES
Write procedures and templates and co-ordinate with PM for execution.
Plan and perform equipment and product qualifications.
Co-ordinate/ perform utilities qualification studies.
Co-ordinate/perform sterilisation/sanitisation validations studies.
Co-ordinate/perform thermal mapping studies.
Co-ordinate/perform transportation/distribution studies.
Generate, execute or review Plans / Protocols / Reports / SOPs / WIs associated with commissioning, qualification and validation activities.
Maintain qualification and validation files.
Participate as Validation Representative on Project Teams.
Participate in Change Control Programme.
Adhere to company Validation Policies, Guidelines and the Site Validation Master Plan.
Keep abreast of / adhere to regulatory requirements in relation to validation areas of responsibility.
Ensure Project related work is carried out in accordance with the company Validation Policies, Guidelines, Site Validation Master Plan and GMP.
Participate in the Self Inspection programme and External Audits.
Generate APQR reports in area of responsibility.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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