Validation specialist - united kingdom, stevenage, hertfordshire

validation specialist

stevenage - min 3 days on site

permanent

competitive salary, bonus and corporate benefits

an exciting opportunity to join an expanding biopharmaceutical company in a role where you will be responsible for qualification and validation of analytical test equipment, facilities, services, computerised systems and processes, manufacturing systems capable of producing high quality drug products.

the role is based within the manufacturing sites in stevenage but may involve travel to other sites in london.

for you; excellent salary and benefits, performance related bonus as well as private healthcare & dental insurance, life assurance, pension and access to an employee share scheme along with the opportunity for flexible working.

main duties and responsibilities.

* perform qualification and validation of manufacturing equipment, analytical test equipment, facilities, services, computerised systems and processes in line with company procedures, eudralex vol 4 annex 11 and 15, relevant fda regulations and national and international standards.

* write qualification and validation lifecycle documents including impact risk assessments, electronic record, electronic signature and data integrity assessments, gamp assessments, user requirement specifications, design qualification, installation qualification, operational qualification, performance qualification.

* support maintenance of the validation master plan, requalification and periodic reviews of validated facilities, utilities, equipment and processes.

* provide project teams with expert validation guidance and best practices for system

implementation.

* lead and own project plans for more complex validation projects.

* work effectively with and lead cross functional team members to deliver validation projects to

schedule.

* manage work with third-party vendors and suppliers to deliver equipment and validation services to the required company standards.

* author internal company reports and regulatory documentation.

* participate in and support internal and regulatory authority quality inspections. participate in

inspections as a subject matter expert.

* assist in the development and maintenance of validation-related procedures.

* undertake any other reasonable tasks that are requested to help ensure that appropriate

compliance is achieved and maintained within the company's validated systems.

experience and skills.

* prior experience with biopharmaceutical or related industry processes and validation (e)

* prior experience in qualification of biopharmaceutical (or related industry) process equipment and processes (e)

qualifications

* bs or ms in engineering or science-based discipline (p)

skills/specialist knowledge

* strong verbal and written communication skills (e)

* flexible, self-motivated and focus on team outcomes (e)

* understanding of and familiarity with regulatory guidance governing cell-based and

biopharmaceutical development (e)

* excellent team-working and interpersonal skills (e)

* thorough knowledge of cgmp as applied in biopharmaceutical or related industry (e)

* thorough knowledge of cgmp pharmaceutical quality systems (change control, deviation and

capa processes) (e)

* good understanding of cell biology and immunology (p)

for further details, please contact us on

gi group pharmaceuticals provides a tailored account managed service and dedicated pharmaceutical recruitment team and partners with many different pharmaceutical and biotechnology clients throughout the globe and the united kingdom.

gi group holdings recruitment limited group of companies includes gi recruitment limited, draefern limited, gi group recruitment ltd, intoo (uk) limited, marks sattin (uk) limited, tack tmi uk limited and grafton professional staffing limited. we are committed to protecting the privacy of all of our candidates and clients. following some recent changes to data protection laws we have updated our privacy policy. to view a copy and to help you understand how we collect, use and process your personal data please visit the privacy page on our gi group uk website.

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