Capilaux
Process Validation
Job Location
Pampisford, United Kingdom
Job Description
Company: Biotechnology, Diagnostics
Location: Hybrid in Cambridge
Employment Type: Contract or Permanent
About the Role:
We are seeking a skilled Process Validation Lead to support a leading biotechnology company in the successful validation of processes for the production of a diagnostic medical device. The ideal candidate will be adept at managing end-to-end process validation projects within tight deadlines while ensuring compliance with industry standards and regulations.
We are currently exploring this as a contract (outside of IR35) or as a permanent role.
Salary will be dependent on experience and whether contract or permanent, but are inline with current market rates.
Key Responsibilities:
* Lead and execute process validation projects from initiation to completion.
* Develop and implement validation master plans, protocols, and report templates.
* Validate laboratory equipment, including basic and complex instruments such as pipettes, HPLCs, centrifuges, fridges, freezers, and spectrophotometers.
* Ensure compliance with ISO 13485, cGMP guidelines, and related standards.
* Collaborate with cross-functional teams and manage multiple stakeholders effectively.
* Deliver projects within defined timelines, maintaining high attention to detail.
Essential Requirements:
* Significant experience conducting process validation in a laboratory setting under ISO 13485 or equivalent.
* Proven ability to lead process validation projects independently.
* Strong knowledge of ISO 13485 and cGMP guidelines.
* Demonstrated expertise in writing validation master plans, protocols, and report templates.
* Excellent communication and stakeholder management skills.
* Strong organizational skills with the drive to meet tight deadlines.
Desirable Qualifications:
* Experience with risk-based qualification and QC process validation.
* Advanced degree (Master’s or PhD) in Life Sciences or Engineering.
* Background in enzyme manufacturing or the diagnostics industry.
* Experience in project management and creating training materials.
* Ability to conduct in-person training sessions.
We are unable to provide sponsorship for this role. Please ensure that you have the right to work in the UK before applying
Location: Pampisford, GB
Posted Date: 12/22/2024
Location: Hybrid in Cambridge
Employment Type: Contract or Permanent
About the Role:
We are seeking a skilled Process Validation Lead to support a leading biotechnology company in the successful validation of processes for the production of a diagnostic medical device. The ideal candidate will be adept at managing end-to-end process validation projects within tight deadlines while ensuring compliance with industry standards and regulations.
We are currently exploring this as a contract (outside of IR35) or as a permanent role.
Salary will be dependent on experience and whether contract or permanent, but are inline with current market rates.
Key Responsibilities:
* Lead and execute process validation projects from initiation to completion.
* Develop and implement validation master plans, protocols, and report templates.
* Validate laboratory equipment, including basic and complex instruments such as pipettes, HPLCs, centrifuges, fridges, freezers, and spectrophotometers.
* Ensure compliance with ISO 13485, cGMP guidelines, and related standards.
* Collaborate with cross-functional teams and manage multiple stakeholders effectively.
* Deliver projects within defined timelines, maintaining high attention to detail.
Essential Requirements:
* Significant experience conducting process validation in a laboratory setting under ISO 13485 or equivalent.
* Proven ability to lead process validation projects independently.
* Strong knowledge of ISO 13485 and cGMP guidelines.
* Demonstrated expertise in writing validation master plans, protocols, and report templates.
* Excellent communication and stakeholder management skills.
* Strong organizational skills with the drive to meet tight deadlines.
Desirable Qualifications:
* Experience with risk-based qualification and QC process validation.
* Advanced degree (Master’s or PhD) in Life Sciences or Engineering.
* Background in enzyme manufacturing or the diagnostics industry.
* Experience in project management and creating training materials.
* Ability to conduct in-person training sessions.
We are unable to provide sponsorship for this role. Please ensure that you have the right to work in the UK before applying
Location: Pampisford, GB
Posted Date: 12/22/2024
Contact Information
| Contact | Human Resources Capilaux |
|---|