ProClinical is seeking a number of Production Engineers for a biotechnology production company to be based in London on a contract basis. This Production Engineer role will be responsible for the maintenance, calibration, repair, and continual development of all equipment and plant services within the mechanical and electrical scope of the Production Engineering Department with due regard to all relevant regulations, guidelines and practices.
Work to GMP and GxP standards always. (FDA, MHRA, and other regulatory bodies as required.)
- Maintain, calibrate, repair, set-up machinery, equipment, and plant services ensuring continual improvement with due regard to all relevant guidelines and practices detailed below.
- Install, commission, and develop complex pharmaceutical equipment.
- Maintain documentary records relevant to all aspects of the job, both electronic and manual systems.
- Maintain and use GMP documentation for all aspects of the job as expected within a pharmaceutical environment.
- Drive continuous improvement to all engineering processes and procedures through knowledge, innovation and teamwork.
- Provide a calibration service which is in accordance with company procedures and all manufacturing operations.
- Assist with Installation, Operational, and Process Qualification processes for new and existing equipment.
- Carry out autonomous maintenance activities as required.
- Drive and deliver safe working practices in accordance with current legislation and company requirements.
- Act with due regard of current environmental legal requirements and company requirements.
- Ensure that all statutory engineering tasks are carried out in accordance with both legal and company requirements and recorded accordingly.
- Ensure all activities are carried out within the Right First Time principle.
- Make decisions relating to the successful completion of each task in hand, including - but not limited to;
- Root cause identification
- Technical specifications
- Operational requirements
- Maintenance planning and scheduling.
- Ensure that parts and equipment comply with the required quality standards within the pharmaceutical and GMP environment.
- Make technical decisions relating to engineering tasks and their impact on Operations, seeking guidance where necessary.
- Decide on individual work priorities within managerial guidelines.
- Promote the company's core purpose and communications strategy.
- Act as a role model and promote behaviours in keeping with the company's mission and values
Skills and Requirements:
- Experience of working in a pharmaceutical, Food process, FMCG environment including
- a. Packaging lines
- b. Autoclaves
- c. Dry heat sterilizers
- d. Ultra filtration systems
- HNC or equivalent formal qualification in main discipline
- Formal qualification in at least one other engineering discipline
- Formal qualifications for statutory requirements such as B&P, L*, 17th ED
- Evidence of CPD
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 call Ivan Gitardi on +44 203 0789 551 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.