Your Career with SPGL
SPGL helps clients in managing all aspects of quality for their projects and products through the provision of commissioning, integrated commissioning & qualification, construction quality, consulting services (including cleaning and process validation) as well as programme & project management. We serve the needs of all commercial developments and industrial facilities including Pharmaceuticals & Biotechnology, Regulated Consumer Products, Healthcare, Chemicals, Buildings, and Mission Critical Facilities.
SPGL handles multiple projects through alliance agreements with key clients on a global basis. We are always looking for exceptional talent combined with a positive attitude and a strong drive for customer satisfaction.
We are interested in graduates and experienced professionals in the above market sectors. Typically you will need to be educated to a degree level or equivalent in either mechanical or process engineering or science discipline with at least 2 years relevant experience in the above market sectors. The successful candidates will be responsible for compliance with EU and/or USA cGMP requirements, preparation of written commissioning and/or qualification plans, equipments/systems inspections, completion of commissioning/validation documentation (DQ, FAT, SAT, IQ, OQ and PQ protocols) and successful handover to the end user.
Project Engineer/Project Manager
Educated to degree level or equivalent in Project Engineering/Management with at least 2 years relevant experience in the pharmaceutical or biotechnology sectors. The successful candidates will have practical experience in Project Engineering, Project Management, Commissioning, Qualification/Verification covering Facilities, HVAC, Utilities and/or Equipment. You will have good technical and organizational skills to lead small or large projects in the highly regulated environment of Pharma and Biotech.
Educated to degree level or equivalent in mechanical or process engineering with 3 – 5 years relevant experience in the pharmaceutical or biotechnology sectors. The successful candidates will be responsible for preparation of written commissioning plans and method statements, review of vendor documentation, equipment/system inspection, startup and commissioning, completion of commissioning documentation and successful handover to end user.
Educated to degree level or equivalent in either an engineering or sciences discipline with 3 – 5 years relevant experience in API, biotechnology or secondary manufacturing sectors. The successful candidates will be responsible for generation and execution of qualification/validation documentation. This will include generation and execution DQ, FAT, SAT, IQ, OQ and PQ protocols and generation of summary reports. Candidates must have practical experience of qualifying facilities, utility systems and process equipment.
Computer System Validation
Educated to degree level or equivalent with a minimum of 5 years relevant experience in validation of control/computer systems. The successful candidates will be responsible for generation and execution of validation documentation for computer and control systems including PLC and DCS systems. Candidates must be familiar with GAMP and 21 CFR Part 11 requirements, PAT, HACCP and Six Sigma.
Educated to degree level or equivalent with a minimum of 5 years relevant experience in a regulatory compliance or quality assurance role. The successful candidate will be responsible for reviewing completed commissioning and qualification documentation to ensure compliance with cGMP requirements. Acting as the client representative in developing URS, conducting critical analysis and risk assessments.
Laboratory System Validation
Educated to degree level or equivalent in a science discipline with 3 – 5 years relevant experience. The successful candidate will be responsible for generation and execution of DQ, FAT, SAT, IQ, OQ and PQ protocols for laboratory instrumentation. Candidates must have practical experience of qualifying laboratory equipment such as HPLC, UV, NIR, GC, etc. Previous experience in the validation of a computerised laboratory system such as LIMS would be an advantage.
SPGL operates in accordance with the requirements of cGMP and appropriate training will be provided to all candidates in the SPGL Quality System and SOPs.
A competitive salary and benefits package will be offered. Please send full career details for all spontaneous applications to firstname.lastname@example.org