My client is seeking a highly skilled CSV (Computer Systems Validation) Contract Engineer to join their team and provide regulatory support and expertise for various systems used in pharmaceutical manufacturing and laboratory environments. The ideal candidate will have experience in validating and supporting systems such as Maximo, SAP, Infinity, MES, Delta V, and other local laboratory systems.
Responsibilities:
- Qualification and validation of systems including Maximo, SAP, Infinity, MES, Delta V, and local laboratory systems.
- Support new system introductions and ensure the smooth operation of changes to existing systems.
- Develop protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases of the system life cycle.
- Conduct periodic reviews and assessments of validated systems to ensure ongoing compliance.
- Provide support for new hires to familiarize them with both new and existing systems.
- Contribute to a large-scale project in the laboratory, replacing existing systems reaching the end of their life cycle.
- Utilize expertise in both manufacturing and laboratory systems, with a focus on pharmaceutical and medical device validation and automation.
Requirements:
- Bachelor's degree in Engineering, Computer Science, or related field.
- 3-5 years of experience in a GMP (Good Manufacturing Practices) environment, with a focus on CSV, validation, and automation.
- Strong understanding of regulatory requirements and guidelines related to pharmaceutical and medical device manufacturing.
- Experience with a variety of systems including Maximo, SAP, Infinity, MES, Delta V, and laboratory systems is highly beneficial.
- Excellent communication and teamwork skills, with the ability to collaborate effectively with cross-functional teams.
- Ability to work independently and manage multiple projects simultaneously.
- Experience with validation life cycle processes including IQ, OQ, PQ, and periodic reviews.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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