Job Title: CSV Engineer - Pharmaceuticals Services
Company Overview: Our client is a leading provider of comprehensive pharmaceutical services, dedicated to delivering innovative solutions and high-quality products to the pharmaceutical industry. Our mission is to support the development and manufacturing of life-saving medications that improve patient outcomes worldwide. We are currently seeking a highly motivated and skilled CSV (Computer System Validation) Engineer to join our dynamic team and contribute to our mission.
Job Overview: As a CSV Engineer at [Company Name], you will play a crucial role in ensuring the compliance, reliability, and efficiency of computerized systems used in the pharmaceutical manufacturing and quality control processes. You will collaborate with cross-functional teams to validate and maintain a variety of software applications, equipment, and systems to meet regulatory requirements and industry standards.
CSV Documentation: Develop, review, and execute validation protocols (IQ, OQ, PQ) for various computerized systems and equipment used in pharmaceutical manufacturing, laboratory operations, and quality control processes.
Compliance Assurance: Ensure that computerized systems adhere to regulatory guidelines such as FDA 21 CFR Part 11, EU GMP Annex 11, and other relevant regulations. Participate in audits and inspections to demonstrate compliance.
Risk Management: Conduct risk assessments to identify and mitigate potential risks associated with computerized systems. Implement appropriate controls and measures to maintain system reliability and data integrity.
System Implementation: Collaborate with IT, manufacturing, and quality teams to ensure successful implementation and integration of new computerized systems. Validate system configurations, interfaces, and functionality.
Change Control: Manage change control processes for computerized systems, including assessing and documenting the impact of changes, performing impact assessments, and updating validation documentation as needed.
Troubleshooting and Maintenance: Investigate and resolve issues related to computerized systems, including performance deviations, data discrepancies, and system failures. Provide technical support and troubleshooting expertise to ensure uninterrupted operations.
Training and Documentation: Provide training to users and stakeholders on system operation, data integrity best practices, and compliance requirements. Maintain accurate and up-to-date validation documentation.
Continuous Improvement: Identify opportunities for process optimization, efficiency improvements, and enhanced data integrity within computerized systems. Collaborate with teams to implement improvements and best practices.
- Bachelor's degree in Engineering, Computer Science, or related field. Master's degree is a plus.
- Minimum of 5 years of experience in computer system validation within the pharmaceutical or related industry.
- In-depth understanding of regulatory requirements and guidelines, including FDA 21 CFR Part 11 and EU GMP Annex 11.
- Proficiency in validation protocols (IQ, OQ, PQ), risk assessment, change control, and other validation-related activities.
- Strong analytical and problem-solving skills, with the ability to troubleshoot technical issues effectively.
- Excellent communication and interpersonal skills to collaborate across multidisciplinary teams.
- Detail-oriented mindset with a commitment to maintaining data integrity and compliance.
- Experience with laboratory information management systems (LIMS), manufacturing execution systems (MES), and other relevant software is a plus.
- Relevant certifications (e.g., Certified Validation Professional) are desirable.
Join our team and contribute to our mission of ensuring the highest standards of compliance, quality, and safety in pharmaceutical manufacturing. Apply today by submitting your resume and a cover letter detailing your relevant experience and passion for the pharmaceutical industry.