Senior Facilities Compliance Engineer
A leading biotechnology company is recruiting a Senior Facilities Compliance Engineer to their office in Cambridge. The organisation applies innovative technologies and revolutionary assays to the analysis of genetic variation and function, allowing for the realisation of personalised medicine. This is an exciting opportunity to work with a company that prides itself on its rapid advances in the industry.
- Collaborate with Quality, Departmental Stakeholders, and other regional and global functions establish requirements and specifications for Facilities.
- Develop and maintain the regional Facilities compliance action plan.
- Support turnkey and infrastructure projects on compliance and validations requirements.
- Develop guidelines, processes, and procedures for facilities compliance with appropriate standards and regulations.
- Engage Facilities Operations, Real Estate, and Construction management Teams to fulfil all required Compliance requirements in the action plan.
- Manage non-conformities (including root cause investigation) and CAPAs and follow up on the corrective actions.
- Take ownership of the Facilities change control process.
- Develop Validation-related documents (e.g. Validation Master Plans, protocols, and risk assessments) and ensure effective implementation.
- Review technical documents to support compliance requirement.
- Create and update documents for Compliance requirements.
- Conduct training for Compliance-related scopes.
- Lead for facilities in ISO and other regulatory certification programs.
- Carry out internal audits of the facilities Department compliance.
- Ensure that all company procedures and policies are complied with and carried out accordingly.
- Establish improvement through risk-based thinking and analysis.
Skills and Requirements:
- Diploma or bachelor's degree in Mechanical, Electrical Engineering, or equivalent disciplines.
- 5 - 8 years' relevant working experience, preferably in Biotech, Pharmaceutical, or Semiconductor facilities environment
- Familiarity with regulatory guidelines and industry standards.
- Experience in leading Compliance related initiatives and projects.
- Experience in establishing documentations and protocols.
- May need to travel to support regional projects.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Katty Maia at +44 2038543317 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.