Digital CMC Configuration Specialist
Are you passionate about harnessing the power of digital platforms to revolutionize pharmaceutical manufacturing? Join our innovative team as a Digital CMC Configuration Specialist and become a vital driver of transformation within our Product Lifecycle Management (PLM) program. In this dynamic role, you will be at the forefront of configuring, validating, and optimizing manufacturing data within cutting-edge digital systems, ensuring data integrity, compliance, and process excellence. Be part of a collaborative environment that supports accelerated delivery and sustainable internal PLM capabilities, making a tangible impact on the future of life sciences.
Key Responsibilities
- Collaborate with SMEs from Technical Services, Manufacturing Science, Quality Assurance, and Process Development to design and translate product control strategies into the digital PLM system.
- Perform hands-on configuration and data entry within digital PLM CMC platforms, maintaining strict adherence to data standards, controlled vocabularies, and GMP requirements.
- Support the digitization of PFD and Specification documents, resolving discrepancies and ensuring accurate data migration.
- Conduct data integrity checks and support critical build tasks, including data transfer and documentation updates.
- Lead end-to-end PLM deployment tasks, including project planning, risk management, and stakeholder engagement at the Kinsale manufacturing site.
- Drive business process harmonization across sites and identify opportunities to accelerate PLM adoption.
- Support training, knowledge transfer, and continuous improvement initiatives, fostering a culture of learning and innovation.
Required Skills & Qualifications
- Strong understanding of PLM CMC master data, product lifecycle, and regulatory compliance principles.
- Hands-on experience with digital CMC systems such as QbDVision.
- Familiarity with GMP, GDP, data integrity, and validation processes.
- Excellent project management, stakeholder communication, and problem-solving abilities.
- Proficiency in configuration, data migration, and issue resolution within regulated environments.
- Strong analytical, decision-making, and collaborative skills in global and cross-functional settings.
Preferred Education and Experience
- Bachelor's or Master's degree in Life Sciences, Engineering, Business, or Information Systems.
- At least 3 years of experience in the pharmaceutical or life sciences industry.
- Prior experience with PLM systems, especially QbDVision, and pharmaceutical manufacturing environments is highly desirable.
Ready to advance your career in a role that challenges and rewards? If you're detail-oriented, innovative, and eager to contribute to a pioneering team, we want to hear from you. Take the next step and apply now to become part of an industry leader shaping the future of life sciences.
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
