CSV (Delta-V) Engineer
Date Posted: May 10, 2024
Job Description
We are currently seeking a skilled CSV Engineer with expertise in Delta-V automation systems to join our team in Singapore’s pharmaceutical industry. The ideal candidate will play a crucial role in designing, implementing, and optimizing computerized systems validation (CSV) processes to ensure compliance with regulatory requirements and industry standards.
Key Responsibilities
- Design, develop, and implement CSV strategies and protocols for Delta-V automation systems used in pharmaceutical manufacturing processes.
- Collaborate with cross-functional teams to gather requirements, assess system functionalities, and develop validation plans aligned with project timelines and regulatory expectations.
- Execute validation protocols, including IQ/OQ/PQ (Installation Qualification, Operational Qualification, Performance Qualification), to ensure the integrity, reliability, and compliance of Delta-V systems.
- Perform risk assessments and impact analyses to identify potential validation gaps and develop mitigation strategies.
- Generate validation documentation, including validation plans, protocols, reports, and standard operating procedures (SOPs), in compliance with regulatory guidelines and company standards.
- Lead and participate in validation activities, such as system configuration, testing, documentation review, and deviation resolution.
- Provide technical expertise and support to project teams, including troubleshooting CSV-related issues and implementing corrective actions.
- Stay abreast of regulatory requirements, industry best practices, and technological advancements in CSV and Delta-V systems to ensure continuous improvement and compliance.
- Liaise with regulatory agencies and auditors during inspections and audits, providing documentation and support as needed.
Required Qualifications and Skills
- Bachelor’s degree in Engineering, Computer Science, or a related field.
- Minimum of 5 years of experience in CSV engineering within the pharmaceutical industry, with a focus on Delta-V automation systems.
- In-depth knowledge of regulatory requirements, including FDA 21 CFR Part 11, GAMP 5, and EU Annex 11, as they relate to CSV.
- Proficiency in Delta-V system administration, configuration, and troubleshooting.
- Experience in executing validation protocols and documenting validation activities according to regulatory standards.
- Strong analytical and problem-solving skills, with the ability to assess complex systems and identify compliance risks.
- Excellent communication skills, both verbal and written, with the ability to interact effectively with cross-functional teams and regulatory agencies.
- Detail-oriented mindset with a commitment to accuracy and quality in validation documentation and processes.
- Ability to work independently and collaboratively in a fast-paced, dynamic environment, managing multiple priorities effectively.
If you are keen to grow your career with this job, apply with us and send us your resume now. All shortlisted candidates will be contacted shortly.
Reference no.: 122-4948-2918-NW
Registration no.: 968446516E
