Process Validation Expert - Biopharmaceuticals

Location
Berkshire
Salary
Dependent on experience
Posted
11 Aug 2017
Closes
08 Sep 2017
Ref
J4263
Contact
Gregory Hammond
Contract Type
Permanent
Hours
Full Time
A fantastic opportunity has become available for a Lead Process Validation Expert to join a world leading Biotechnology company based in the Berkshire area. As the Lead Process Validation Expert you will be Recognized and established senior Subject Matter Expert responsible for providing the technical oversight of all aspects of process validation working directly with the customers to ensure the successful commercialization of processes from laboratory through to GMP manufacturing.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Lead Process Validation Expert will be varied however the key duties and responsibilities are as follows:

1. Responsible for the technical oversight of commercialization process validation execution and directs technical subject matter experts, validation via others, in Quality and Regulatory functions to ensure successful outcomes.

2. Represents the company manufacturing science and technology technical capability in preparation and execution of regulatory submissions. Represents the manufacturing science and technology function working cross functionally with research and technology and process development to implement to desired timelines on innovative and new process technologies

3. Contributes to the development and implementation of structured technical process validation training and sharing best practices at a team and site level to ensure continuous improvements in project tech transfer execution and personnel/professional development of staff.

4. Proactively anticipates and evaluates trends of innovation within manufacturing science and technology and technically lead site application and implementation including project management, working cross functionally to resolve barriers and delays.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Lead Process Validation Expert we are looking to identify the following on your profile and past history:

1. Relevant degree in a Biotechnology, Biochemistry, Biochemical Engineering or similar along with significant experience within the biopharmaceutical industry.

2. Proven industry experience in preparing validation master plans for either process or equipment validation.

3. A working knowledge and practical experience with upstream or downstream bioprocessing systems and ideally working with tech transfer projects to GMP.

Key Words: Validation | Bioprocess | Upstream | Downstream | Process | Equipment | Validation Master Plan | GMP | Tech Transfer | Biopharmaceuticals |

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.

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