Validation Engineer
- Bern
- Contract
- Commissioning, Qualification and Validation
This vacancy has now expired
Our client, one of the world’s leading biotechnology companies, is currently looking for a Validation Engineer to support the project work on their new state-of-the-art Biotech production facility located near Bern in Switzerland.
Responsibilities:
- Preparation and execution of validation protocols involving facilitates equipment, utilities and associated automation.
- Preparation, review and approval (as required) of SOPs, validation deviations, change control, validation summary reports and associated documentation.
- Management and co-ordination of validation activities with internal departments, external contractors and suppliers.
- Prepare and deliver cross functional training in validation methodologies, protocols and related procedures to facilitate validation activities.
- Primary point of contact for validation related issues arising during validation activities (including protocol execution).
- Investigation of deviations / non-conformances to determine [potential] impact on product quality, validation status and associated compliance requirements.
- Partners with functional departments to perform deviation root cause analysis and formulate corrective / preventative actions (CAPA).
- Performance of risk and impact assessments associated with validation activities, deviations and changes.
- Provides support to commissioning activities, including review of commissioning plans, procedures, turnover packages etc. (as required).
- Provide guidance on validation requirements and expectations to validation engineers and project team.
- Represent validation as a subject matter expert (SME) in all project phases (including commissioning and qualification execution).
- Represent the validation program and designated validation activities during inspection by regulatory agencies and Quality Regulatory functions.
- Review of technical documents / reports to ensure that validation activities are consistent with current company, industry, regulatory requirements, and current technology.
Requirements
- 3-7 years of experience in a Validation/Quality role in a biopharmaceutical manufacturing environment. Large scale project experience
- Thorough knowledge of biotechnological technologies, processes and clean utilities.
- Demonstrated proficiency in Good Practice requirements (GMP, GEP) as well as biopharmaceutical industry regulations and norms as they relate to validation.
- Strong technical writing and communication skills in English. German an advantage.
- The ability to take pragmatic and compliant decisions.
- Highly motivated to take ownership and responsibility for assignments.
- Ability to take the initiative with minimal supervision
- Proficiency in MS Word, MS Excel and MS Project.
This is a great opportunity to work for a company which is one of the pioneers in biotechnology, led by world-class research and development, advances the latest science and leading-edge technologies to create, commercialize, and manufacture transformative therapies for patients with few or no treatment options.
To apply or for further information get in touch today!
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
To view Quanta's privacy policy, please visit our website
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 Quanta for seven years now and have always received a professional service. Quanta’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 Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
I have always received a highly professional & personable service from the team at Quanta. 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
Save as job alert
Similar Jobs
Salary
Competitive
Location
Cork
Salary
Competitive
Sector
Commissioning, Qualification and Validation
Job type
Contract
Location
Cork
Description
C&Q Lead - Buffer Prep - Pharmaceuticals - Cork - 12-Month Contract Located in Ireland, our Global pharmaceutical client is looking for C&Q Lead to join their state of the art pharmaceutical
Reference
32139
Expiry Date
01/01/0001
Author
James SmithsonAuthor
James SmithsonSalary
Competitive
Location
County Dublin
Salary
Competitive
Sector
Commissioning, Qualification and Validation
Job type
Contract
Location
Dublin
Description
Cleaning Validation Engineer - Dublin, Ireland - 12-Month Contract Are you interested in joining a world leading biopharmaceutical company, focused on developing advanced and innovative
Reference
33487
Expiry Date
01/01/0001
Author
Claire HabershonAuthor
Claire HabershonSalary
Competitive
Location
Dublin
Salary
Competitive
Sector
Commissioning, Qualification and Validation
Job type
Contract
Location
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 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.
Franziska
I manage this role.