Regulatory and Validation Services Specialist
Upto £50K with generous pension
This new role presents a fantastic opportunity to join a Global Regulatory and Validation Services team
at an award-winning, global engineering company and for over 60 years has manufactured components and systems for a range of industries. This role sits within the newly formed Marketing Directorate, linking together; Product Management, Business Development, Marketing Services, Training and Regulatory and Validation Services.
The company are going an exciting growth plan and this is the perfect time to be part of this incredible journey.
This role is key to the continued development of the company's technical strategy to support their customers within the BioPharm and Medical Diagnostics sectors with regulatory, validation and qualification documentation on products.
Reporting to the Global Regulatory and Validation Services Manager, you will be responsible for coordinating product validation and regulatory documentation updates from supply chain, engineering and product management. This will involve maintaining a database of group-wide documents relating to product validation and compliance documentation. This role involves working collaboratively with teams within supply chain, quality, design/ project engineering, project management and marketing. With a keen eye to detail and a customer facing approach, the role requires developing test protocols and executing of product validation test programs and reporting data to internal stakeholders and customers.
Ideally located near Portsmouth UK, however location could be flexible at another of our facilities depending on the right candidate.
Qualifications and Experience:
Bachelor's degree in Chemistry, Microbiology, Biology, Engineering or similar.
Minimum of 4 years in a scientific or engineering background.
Experience of working in a project environment.
Understanding of cGMP requirements.
Experience in Biopharmaceutical industry or supplier to Biopharmaceutical, or in a Medical Device company
Experience of writing and executing test protocols.
Demonstrate excellent verbal and written communication skills
Good technical and analytical judgement
Team player - achieving through teams.
Self-motivated and positive attitude to work.
Able to work under pressure.
Ability to influence and guide management decision making.
Experience of IQ/OQ/PQ validation of process equipment is a plus.
Experience of a customer facing environment is a plus.
Ability to communicate and negotiate whilst building relationships with different stakeholder groups within the organization
The position comes with a highly competitive remuneration package including pension, sickness benefits and career development prospects.
The company core values are very important to them and they are committed to promoting equality, diversity and inclusivity within the workplace. They offer a range of staff benefits including accessible employee forums, comprehensive pension packages, flexible working arrangements and inclusive employment practices