Validation Manager
- Recruiter
- Confidential
- Location
- Edinburgh
- Salary
- Competitive
- Posted
- 14 Jun 2022
- Closes
- 12 Jul 2022
- Sectors
- Health, Nursing & Social Care
- Contract Type
- Permanent
- Hours
- Full Time
We are looking for a driven individual to join our Validation team as a Validation Manager.
We are RoslinCT, a world-leading cell and gene therapy contract development and manufacturing organisation creating cutting-edge therapies that change people's lives. Collaborative, dedicated and talented people are at the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilising ground-breaking science.
As part of our continued growth, we are now recruiting across all of our teams including this Validation Manager role. This is an excellent opportunity for an experienced Validation professional to lead a talented team in the growing cell and gene therapy sector.
The Role:
You will lead our Validation team and hold responsibility for supervising activities relating to the regulatory compliance of RoslinCT's facilities and equipment validation activities, including the preparation and execution of validation protocols and reports. The ideal candidate will hold prior experience in GMP sterile Manufacturing validation programmes.
Responsibilities:
Work at RoslinCT is fast paced, and no two days are the same. Your responsibilities will therefore be varied, but will include;
* Planning, supervising and executing, as appropriate, RoslinCT's validation activities including product, facility and both new and existing equipment validation, qualification and re-verification in accordance with GXP.
* Ensuring a risk-based approach is applied to validation activities in accordance with industry guidance.
* Providing regular reports to RoslinCT Management on the status of validation tasks, alongside the periodic evaluation of processes, facilities and equipment to ascertain their status.
* Supervising and co-ordinating the preparation and execution of validation protocols and reports.
* Ensuring Cleaning validation and hold time programmes are delivered in a timely manner.
* Providing CSV support including operation and retirement of suitable qualified/validated computer systems.
* Ensuring data integrity is continuously developed within the QMS.
* Completion and review of quality related documentation including Validation documents, change controls, incidents/deviations and risk assessments in line with GMP and SOPs.
* As appropriate, communication of procedures and results with clients.
* Ensuring training needs of the Validation team are met.
* Line managing Validation team members, being responsible for managing employee performance and professional development with appropriate support from Management and our HR.
* Undertaking regular 1-2-1 meetings with Validation team members and holding team meetings to foster a professional, inclusive and supportive team environment.
Qualifications:
You will hold a degree in a Life Sciences or related subject or equivalent relevant training and experience.
Skills and Experience:
You will be able to demonstrate:
* Experience in management of GMP validation programmes including CSV and Data Integrity.
* Experience in GMP sterile or cleanroom Manufacturing.
* Experience in supervising a team.
Benefits:
In addition to a competitive salary and the opportunity to join an exciting, rapidly expanding company delivering life-changing therapies, we offer:
* ???31 days of annual leave, plus 4 public holidays - when you have been with us for three years, we will give you an extra day holiday and when you reach 5 years, you'll get an extra two days' holiday.
* Competitive company pension scheme - we contribute up to 8% of your salary (depending on length of service) to ensure that you are all set for the future.
* Group Life Cover - you are automatically covered for three times your basic salary to give you peace of mind for you and your family.
* Healthcare Cashback and Mental Health/Wellbeing support our Healthcare plan.
* Staff discounts on food, drink, electronics, entertainment and electricals.
* Access to our Cycle2Work Scheme so you can save up to 42% on a new bike to help with your commute and wellbeing.
* We have a dedicated Social Committee and other regular company events such as BBQs, team drinks, quizzes, parties and 5-aside football.
* Career Progression & Training Opportunities are provided for all of our staff to help you achieve your goals and grow professionally and personally.
Values:
A key part of working at RoslinCT is being able to embody our company values, which are integral to the work we do here. As such, you should be able to demonstrate:
* Passion for customer satisfaction.
* Ability to support a 'one team' approach.
* Great communication.
* Commitment to personal growth and development.
* Accountability for your work.
Location:
We are based at Edinburgh BioQuarter, which acts as a hub for Scottish Life Science with close links to the University and the Royal Infirmary.
Employer Value Proposition:
RoslinCT is seeking the best, brightest, and most passionate cell and gene therapy talent with a diverse range of skillsets, experience, and perspectives. We offer industry-leading annual leave allowances, career development opportunities and employee benefits, as well as working groups and social activities, and are dedicated to developing the next generation of experts and future leaders of our company. If you want to utilise your skills and talent in a state-of-the art company that truly changes lives, you belong at RoslinCT
We are RoslinCT, a world-leading cell and gene therapy contract development and manufacturing organisation creating cutting-edge therapies that change people's lives. Collaborative, dedicated and talented people are at the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilising ground-breaking science.
As part of our continued growth, we are now recruiting across all of our teams including this Validation Manager role. This is an excellent opportunity for an experienced Validation professional to lead a talented team in the growing cell and gene therapy sector.
The Role:
You will lead our Validation team and hold responsibility for supervising activities relating to the regulatory compliance of RoslinCT's facilities and equipment validation activities, including the preparation and execution of validation protocols and reports. The ideal candidate will hold prior experience in GMP sterile Manufacturing validation programmes.
Responsibilities:
Work at RoslinCT is fast paced, and no two days are the same. Your responsibilities will therefore be varied, but will include;
* Planning, supervising and executing, as appropriate, RoslinCT's validation activities including product, facility and both new and existing equipment validation, qualification and re-verification in accordance with GXP.
* Ensuring a risk-based approach is applied to validation activities in accordance with industry guidance.
* Providing regular reports to RoslinCT Management on the status of validation tasks, alongside the periodic evaluation of processes, facilities and equipment to ascertain their status.
* Supervising and co-ordinating the preparation and execution of validation protocols and reports.
* Ensuring Cleaning validation and hold time programmes are delivered in a timely manner.
* Providing CSV support including operation and retirement of suitable qualified/validated computer systems.
* Ensuring data integrity is continuously developed within the QMS.
* Completion and review of quality related documentation including Validation documents, change controls, incidents/deviations and risk assessments in line with GMP and SOPs.
* As appropriate, communication of procedures and results with clients.
* Ensuring training needs of the Validation team are met.
* Line managing Validation team members, being responsible for managing employee performance and professional development with appropriate support from Management and our HR.
* Undertaking regular 1-2-1 meetings with Validation team members and holding team meetings to foster a professional, inclusive and supportive team environment.
Qualifications:
You will hold a degree in a Life Sciences or related subject or equivalent relevant training and experience.
Skills and Experience:
You will be able to demonstrate:
* Experience in management of GMP validation programmes including CSV and Data Integrity.
* Experience in GMP sterile or cleanroom Manufacturing.
* Experience in supervising a team.
Benefits:
In addition to a competitive salary and the opportunity to join an exciting, rapidly expanding company delivering life-changing therapies, we offer:
* ???31 days of annual leave, plus 4 public holidays - when you have been with us for three years, we will give you an extra day holiday and when you reach 5 years, you'll get an extra two days' holiday.
* Competitive company pension scheme - we contribute up to 8% of your salary (depending on length of service) to ensure that you are all set for the future.
* Group Life Cover - you are automatically covered for three times your basic salary to give you peace of mind for you and your family.
* Healthcare Cashback and Mental Health/Wellbeing support our Healthcare plan.
* Staff discounts on food, drink, electronics, entertainment and electricals.
* Access to our Cycle2Work Scheme so you can save up to 42% on a new bike to help with your commute and wellbeing.
* We have a dedicated Social Committee and other regular company events such as BBQs, team drinks, quizzes, parties and 5-aside football.
* Career Progression & Training Opportunities are provided for all of our staff to help you achieve your goals and grow professionally and personally.
Values:
A key part of working at RoslinCT is being able to embody our company values, which are integral to the work we do here. As such, you should be able to demonstrate:
* Passion for customer satisfaction.
* Ability to support a 'one team' approach.
* Great communication.
* Commitment to personal growth and development.
* Accountability for your work.
Location:
We are based at Edinburgh BioQuarter, which acts as a hub for Scottish Life Science with close links to the University and the Royal Infirmary.
Employer Value Proposition:
RoslinCT is seeking the best, brightest, and most passionate cell and gene therapy talent with a diverse range of skillsets, experience, and perspectives. We offer industry-leading annual leave allowances, career development opportunities and employee benefits, as well as working groups and social activities, and are dedicated to developing the next generation of experts and future leaders of our company. If you want to utilise your skills and talent in a state-of-the art company that truly changes lives, you belong at RoslinCT