Computer System Validation (CSV) Engineer

Loughrea, Co. Galway

BASIC SUMMARY:

Chanelle Pharmaceutical is a leading Pharma company committed to delivering high-quality products and services. We prioritize compliance, efficiency, and innovation, striving to maintain the highest standards in all our operations.

 

The Computerized Systems Validation (CSV) Engineer will oversee and perform computer systems validation activities enterprise-wide, ensuring that business processes required to operate are qualified and maintained in a validated state according to company directives and procedures. The successful candidate will have advanced knowledge and experience developing and leading CSV and Life-cycle management activities to support GxP conforming systems, facilities, manufacturing and laboratory systems. The CSV Engineer understands industry-wide and Regulatory expectations for computer system validation and works with members of IT, QA, and other departments to ensure that Computerized System Validation (CSV) packages are consistent with validation plans and standard operating procedures and utilizes industry experience to identify continuous improvement opportunities for CSV practices.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Conception, planning and performing of Computer Systems Validation (CSV) in the regulated environment.
  • Advisory and support of application owners to build and maintain GxP conforming systems and ensure compliance with applicable regulations and industry standards.
  • Develop strategies for and drive Implementation of qualification/validation requirements for new and existing computer systems.
  • Development and implementation of IT procedures that adhere to Data Integrity requirements as defined in applicable regulation for Raw-Data-Handling systems and solutions.
  • Oversee and perform computer system validation activities and ensures the approach and execution aligns to applicable regulations, GAMP 5, and Chanelle’s directives and procedures.
  • Develop/enhance and implement Computer Systems Validation documentation such as VPs, Test Scripts, Assessments, Reports, SOPs, Policies.
  • Support the implementation and adoption of the global CSV program and remediation.
  • Support data integrity implementation and remediation for systems within CSV program.
  • Participate in audits and continuous improvement efforts related to CSV program.
  • Support Chanelle to achieve all CSV site and corporate goals.

    COMPETENCIES:

    • Strong knowledge of regulatory requirements (FDA 21 CFR Part 11, EMA, GAMP).
    • Excellent analytical and problem-solving skills.
    • Proficiency in validation documentation and technical writing.
    • Ability to work independently and in a team environment.
    • Strong organizational skills and attention to detail.
    • Effective communication and interpersonal skills.

     

    QUALIFICATIONS:

    • Bachelor’s Degree (BS) with an emphasis in Engineering/Life Sciences or equivalent.
    • A minimum of 5 years relevant CSV experience, preferably in the biotech / pharma industry.
    • Direct experience with IT and MFG automation systems supporting GMP manufacturing.
    • Direct experience implementing CSV activities to support GxP systems.
    • Direct/ hands-on experience with validation of enterprise systems (e.g., ERP, LIMS, MES).
    • Strong knowledge of FDA and cGMP regulations and documentation practices.
    • Strong knowledge of GAMP 5.
    • Strong knowledge of 21 CFR Part 11 and Annex 11.
    • Strong knowledge of computer system validation methodologies.

PHYSICAL DEMANDS: Health & Safety requirements (eg. Manual Handling Training)

  • To take reasonable care for their own safety, health and welfare at work and that if aby other person that may be affected by their actions or omissions while at work
  • To co-operate with Chanelle or any of its representatives that will enable the company to comply with the relevant health and safety statutory provisions. 
  • Adheres to safety regulations by ensuring correct usage of PPE in laboratory and production areas
  • Reports to the supervisor or health and safety representative without unreasonable delay of any defects in plant, equipment, place of work, system or work which might endanger safety, health or welfare of themselves or any employee, contractor or visitor to the company
  • Keeps work area safe, clean and tidy
  • Required Training: 
    • Manual Handling Training
    • Working on PC

      PERSON SPECIFICATION:

      • Sc. / M.Sc. in Engineering / LifeScience
      • Minimum 5 years relative experience in a similar position
      • Demonstrated ability to work and communicate effectively cross-functionally with at all levels of management
      • Proactive, motivated, analytical and strategic

       

      WORK ENVIRONMENT: (eg. Office, Production)

      • Office

Computer System Validation (CSV) Engineer

Reference No: J0755
Loughrea, Co. Galway