PQE Group - CSV Specialist - PLC/SCADA/HMI (2-7 yrs)

Key Responsibilities :

- Develop and execute comprehensive CSV protocols and plans for various computer systems, including but not limited to:

1. Laboratory systems (Chromeleon, LIMS, Empower)

2. Engineering systems ( PLC, SCADA, HMI, MES)

3. Manufacturing systems

3. Clinical Trial Management Systems (CTMS)

4. SAP systems

- Conduct risk assessments and identify potential compliance gaps related to computer systems.

- Perform thorough system assessments, including data integrity reviews, to ensure compliance with ALCOA+ principles.

- Author and review validation documentation, including protocols, reports, and deviations.

- Collaborate effectively with cross-functional teams (i.e., IT, Quality, Engineering, Validation) to ensure successful project delivery.

- Stay abreast of evolving regulatory requirements and industry best practices in CSV.

- Provide guidance and support to internal stakeholders on CSV-related matters.

- Travel domestically and internationally as required for project support.

Required Skills and Experience :

- Strong understanding of CSV principles and methodologies, with a focus on regulated industries (Pharmaceutical, Biotech, Medical Devices).

- In-depth knowledge of relevant regulations, including 21 CFR Part 11, EU Annex 11, and GAMP 5.

- Proven experience in validating various computer systems, including those listed above.

- Expertise in data integrity principles (ALCOA+) and their application in CSV.

- Excellent written and verbal communication, interpersonal, and presentation skills.

- Strong analytical and problem-solving abilities.

- Ability to work independently and as part of a team.

- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

- Experience with CSV software tools (optional).

Desired Skills :

- Experience with specific software applications (Chromeleon, LIMS, Empower, PLC, SCADA, HMI, MES, SAP).

- Knowledge of Excel sheet validation techniques.

- Experience in infrastructure qualification