Howdy, we are glad to inform you that PM Group is looking for a process specialist with a background in sterile manufacturing to support the design and installation of new GMP process equipment at a pharmaceutical site in Sweden.
·Working on the project’s process elements, particularly focusing on for selection, design and startup of GMP process equipment.
·Analyzing performance of new process equipment, meeting KPIs.
·Leading the project’s process engineering design, ensuring all design elements are in-keeping with client SHE and GMP compliance procedures.
·Developing design specifications and P&IDs.
·Producing and maintaining mass balance documentation.
·Working with and challenging the principle contractor in the project design and equipment selection.
·Acting as a client representative in meetings and discussions with third party vendors.
·Writing and reviewing URS documents, SOP documents, and other design documentation relevant to the process elements of the projects.
·Working alongside third party contractors and offering input into process design and installation.
·Collaborating with other client departments and offering technical support as required.
·Offering technical knowledge and experience to the design and specification of equipment selection, installation, validation and operation in line with site standards.
·Providing hands-on problem-solving, thorough investigation, and fault-finding expertise.
·Ensuring that GMP, Quality, Health and Safety processes are adhered to in all aspects of role.
·General process improvement, quality design, and risk management.
·Attending FATs, SATs, and similar testings.
·Consideration of maintenance, calibration, and reliability when designing.
·Candidates must have proven experience of working as a process subject matter expert on multiple sterilizing projects in the industry.
·Candidates must have extensive experience of working on fill finish projects in the pharmaceutical sector.
·Knowledge of standard industry practices, procedures and safety measures is essential, including a deep understanding of GMP and process safety practices.
·The successful candidates will have strong leadership and communication skills, including the ability to challenge and work with other technical engineers and project stakeholders.
·Candidates should have a degree in chemical engineering or other relevant discipline.
·Experience in process modelling software would be advantageous.