Lead CSV Engineer
Are you a seasoned CSV professional with a passion for innovation and precision in the biopharma industry? Join our dynamic team as a Lead CSV Engineer and play a pivotal role in shaping the validation strategy for cutting-edge sterile manufacturing facilities. This is your chance to lead complex validation projects, mentor a talented team, and ensure compliance with global regulatory standards-all within a ground-breaking, greenfield environment.
Key Responsibilities:
- Own and implement the sitewide Computer System Validation (CSV) strategy, lifecycle governance, and risk management frameworks for a state-of-the-art facility.
- Oversee the complete validation lifecycle, including Validation Plans, URS, Risk Assessments, IQ/OQ/PQ, and Summary Reports, particularly for sterile equipment and automated platforms.
- Lead and mentor a team of CSV engineers and contractors to meet critical project and commissioning milestones.
- Manage validation efforts across aseptic processing, lyophilization, automated inspection, and fill-finish lines.
- Act as the CSV SME during regulatory audits, ensuring full compliance with GAMP 5, ALCOA+, and 21 CFR Part 11 / Annex 11.
- Collaborate with CQV, IT, Automation, and Operations teams to align validation objectives with operational schedules and strategic goals.
Required Skills & Qualifications:
- Degree in Engineering, Computer Science, or a related Scientific discipline.
- 10+ years of CSV experience within a GMP biopharma environment.
- At least 3+ years in a team lead or project lead role managing validation projects.
- Proven track record on large-scale greenfield capital projects.
- Strong technical expertise in sterile fill-finish, lyophilization, and automated control systems (e.g., DeltaV, MES, SCADA).
- Deep understanding of GAMP 5, Data Integrity (ALCOA+), and international regulatory expectations (FDA, EMA, HPRA).
Preferred Education and Experience:
- Bachelor's or Master's degree in a relevant scientific or technical discipline.
- Extensive experience with validation in high-containment, sterile, and complex manufacturing environments.
- Demonstrated leadership in a fast-paced, regulated setting.
Take the next step in your career-bring your expertise to a project that challenges, develops, and rewards you. Apply now to be part of a pioneering team dedicated to excellence in life sciences manufacturing!
WHY LSC?
LSC work exclusively in the Life Sciences sector. Founded and run by contractors, we understand contracting first-hand and have created a unique approach to make the process as smooth as possible, so you can focus on delivering your best work. With over 23 years' experience supporting the industry, we bring deep sector knowledge and long-standing client relationships. At LSC, we partner with you for the long term, not just the duration of your contract. We are committed to building lasting relationships and will work closely with you to ensure you are placed on projects that challenge, develop, and reward you throughout your career.
Are you currently eligible to work in Ireland? As this is a contract opportunity, you will need to hold a Stamp 1G or Stamp 4 visa to apply. Apply via this advert or contact Paul O'Driscoll on 021 4777329 if you have any questions about this role. Find out more about working with LSC at lscconnect.com
