CQV Engineer
- Midlands (Ireland)
- Contract
- Commissioning, Qualification and Validation
This vacancy has now expired
With worldwide demand for their life-changing oncology treatment increasing; one of our global pharmaceutical clients is looking for a Junior - Mid Level CQV Engineer to join their team to support multiple capital projects taking place onsite in Leinster.
This is a fantastic opportunity to work on a state-of-the art fill-finish facility and the company’s first stand-alone vaccine and biologics plant outside the US.
Role Summary:
- Engage in the early stages of the project, giving input into design by working with equipment vendors and global engineering teams, attending FAT and design reviews to represent client validation interests. Oversee equipment C&Q within the assigned area with a view to ensuring right first-time C&Q and Validation effort.
- Act as C&Q SME on the equipment within the area assigned.
- As such you will be executing with a view to leveraging testing from Commissioning and Qualification to PQ where possible.
- Providing technical and validation oversight to process, design and project delivery teams and coaching to associate staff within the assigned suite.
- Implementing the requirements as outlined in the site / C&Q and project Validation Master Plan.
- Coordination of engineering sub-teams in the assigned suite during execution of IQ/OQ / Cycle Development & Validation activities.
- Authoring and reviewing standard operating procedures and technical reports including IOC/ IOQ & PQ protocols.
- Technical owner of Commissioning protocols, Qualification protocols and input to Validation protocols executed by vendors, cross functional groups and/ or validation counterparts.
- Supporting regulatory submissions as required.
Requirements:
- This role requires an experienced individual with a minimum of 3 years directly related experience in academia, pharmaceutical or biotechnology industry – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
- Minimum 3 years process equipment C&Q/ Validation experience on Large Scale Projects
- SME on Equipment Validation on any of; Parts Washer / Autoclaves / Vaporised Hydrogen Peroxide Sterilising Isolators / Clean Utilities - Transfer Panels & Formulation / Visual Inspection/ Single Use Technologies
- Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines / Revised Annex 1
- Experience with liaising with other departments – engineering, technical, operations and QA
- Experience with sterile processing and sterilisation technologies
- Experience with cleaning and process validation, technology transfer, regulatory filing, and commercial drug product manufacturing of biologics is a plus.
- Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection.
- Autoclave Qualification and Sterilisation Loads Cycle Development experience.
- Use of temperature mapping equipment such as Lives/ Kaye etc. and trending, analysing, and interpreting complex data
If this role is of interest to you, please apply now!
#LI-CH3
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
Save as job alert
WE’RE NOT JUST
ABOUT THE WORK
Although That’s Pretty Awesome
We’re about an unmatched company culture and a huge range of benefits you’ll love, both on and off the clock.
Check out all our perks hereSimilar Jobs
Salary
Competitive
Location
North Carolina
Salary
Competitive
Sector
Commissioning, Qualification and Validation
Job type
Contract
Location
North America
East Coast
Description
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
Reference
36354
Expiry Date
01/01/0001
Author
Emily GainesAuthor
Emily GainesSalary
Competitive
Location
Dublin
Salary
Competitive
Sector
Commissioning, Qualification and Validation
Job type
Contract
Location
Ireland
Dublin
Description
Cleaning Validation Specialist - Pharmaceuticals - 12 Month Contract - Dublin Are you looking for the chance to join a life changing pharmaceutical organisation in their mission to continuously
Reference
30840
Expiry Date
01/01/0001
Author
Tom EvansAuthor
Tom EvansSalary
Competitive
Location
County Dublin
Salary
Competitive
Sector
Commissioning, Qualification and Validation
Job type
Contract
Location
Ireland
Dublin
Description
Process Validation Engineer - Dublin, Ireland - 12-Month Contract Initially Are you looking for the chance to join a life changing pharmaceutical organisation in their mission to continuously
Reference
36058
Expiry Date
01/01/0001
Author
Tom EvansAuthor
Tom EvansInsights
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.
Christopher
I manage this role.