GxP-Blog

Organisation operational Site Service
Chemgineering supports well-known companies in the pharmaceutical and life sciences in mastering the challenges of everyday engineering operations on site.

How big is the workload of your engineering team that ensures the availability of your production systems and is responsible for improving the ongoing processes? Is there also a large investment project pending? Are you in a situation in which enlarging the team is not permitted, but the rules and regulations require ever more extensive documentation of the actual technical state of the systems and ongoing operations in the areas of maintenance and optimization, which ties up resources?

Rising costs and increasing statutory and regulatory requirements, particularly in the life sciences sector, necessitate alternative and efficient engineering methods and channels. In the past, exclusively engineers who worked for the company were assigned to handle technical issues involved in the maintenance and optimization of the value-creating processes, but today the work of the in-house engineering team focuses primarily on organizational and documentary tasks. Thus, it is increasingly difficult for the technical staff of a manufacturing company to concentrate on core technical issues in the implementation of maintenance measures or improvements without neglecting other organizational processes that are essential to companies in this highly regulated sector. Put simply, there are two possible solutions for the company: Either they increase the number of technical staff or they transfer tasks and services to specialized service providers like Chemgineering.

The tasks assigned to the service provider can range from the preparation of a single qualification document to the update of a flow diagram to the complete execution of smaller project and handover to the plant. This has a number of benefits for the client, particularly with regard to CAD. The client doesn’t need to hire permanent staff or maintain the required CAD license. The request for services is handled via a defined contact.

In the areas of engineering and qualification, specialized service providers can meet individual challenges effectively, implementing solutions and meeting targets rapidly. Depending on the task and scope of services, staff with a wide variety of core skills is needed – generalists as well as specialists.

The locally and/or regionally available staff of the service provider is able to take over tasks and projects at very short notice and to relieve the client of these burdens. In this regard, established options include «on-shore» and «near-shore» solutions. In on-shore solutions, the staff members of the service provider work directly on the client’s site. In near-shore solutions, the service provider maintains an office near the client’s site. Both options facilitate short response times and high flexibility. If required, the local team can obtain support from persons in more remote locations («offshore»).

Moreover, the on-shore and near-shore staff of the service provider are usually integrated in the client’s internal quality  training programs. This ensures that the service provider’s staff are up-to-date with the company’s internal standard operating procedures (SOPs).

In addition to the qualified staff on site, the service provider has extensive experience from numerous projects and assignments in the world of pharmaceuticals and chemistry. The client benefits from the cross-sectoral and interdisciplinary knowledge used in designing and implementing the solutions – in other words, the client has extensive state-of-the-art knowledge at his fingertips. The service provider can focus on the task assigned, ensuring high-quality results based on his expertise in conjunction with established, quality-assured processes. This enables the company’s own personnel to focus more intensively on the corporate value creation processes.

The flexible design of the support and the high-quality, efficient and fast processing of the work assigned means that financial resources are used sparingly. Fixed commercial terms and conditions give both partners security in commissioning and execution, facilitating a collaborative partnership.

Outsourcing engineering services in the construction of process-based systems and plants has been practiced for a long time. Even during ongoing operation of plants/systems, the transfer of tasks and services to specialized service providers like Chemgineering improves performance, as the staff of the manufacturing company can focus on the value-creating processes. Chemgineering will be happy to provide you with on-site support in your daily engineering operations.