Freelance Assignment: CSV C&Q Engineer (SME)

UCB

  • Braine-l'Alleud, Brabant Wallon
  • Contrat
  • Temps-plein
  • Il y a 15 jours
Opportunity open to freelance or temporary employed consultant.Make your mark for patientsWe are looking for a CSV Commissioning and Qualification (C&Q) Engineer SME who is detail-oriented, proactive, and collaborative to join us as a freelance in Braine-l'Alleud, Belgium.About the RoleAs a freelance CSV C&Q Engineer SME, you will act as UCB's CSV C&Q Subject Matter Expert, providing expertise and leading the CSV C&Q portion of the project. You will ensure that C&Q activities are completed safely, on schedule, and in compliance with system requirements, specifications, and project procedures/guidelines. Your role will be transversal across GMP equipment.Who You Will Work WithYou will work closely with suppliers, IT SMEs, automation SMEs, and other UCB team members to ensure effective implementation and testing of CSV aspects. You will also interact with various stakeholders to ensure compliance and optimal outcomes.What You Will Do
  • You act as CSV C&Q Subject Matter Expert and Compliance lead for CSV.
  • You provide guidance to suppliers and the UCB team in all CSV C&Q activities.
  • You lead the CSV C&Q strategy based on CSV VMP.
  • You liaise with IT SMEs for correct implementation and testing.
  • You liaise with automation SMEs for correct implementation and testing.
  • You draft or provide technical guidance on document drafting.
  • You drive correct CSV verification testing, compliance, and acceptance.
  • You conduct troubleshooting, deviation investigation, and resolution.
  • You generate and review change controls related to CSV C&Q.
  • You ensure relevant training for personnel performing C&Q activities.
Interested? For this role, we are looking for the following education, experience, and skills
  • Strong knowledge in PCS7 or Delta V
  • 5+ years of C&Q CAPEX experience in biopharma industry
  • Mastery of ISPE, GAMP-5, Annex 15, ASTM E2500 standards
  • Expertise in automated systems (SCADA, DCS, PLC, EMS, BMS…)
  • Knowledge of GMP, safety, and environmental requirements
  • Strong leadership, communication, and decision-making skills
  • Fluent in English; knowledge of French is a plus.
#genetherapyAre you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!About UCB
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.Why work with UCB?
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.Employment or engagementIf you have been selected to work for UCB, please note that you will be formally employed by a staffing agency (in case of being a temporary employed consultant) or engaged via a broker (in case of being a freelancer), to work for UCB.Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

UCB