- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
- We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- Our company will continue to focus on advancing therapies that are the first or best of their kind.
- By providing a foundation for all operations company wide, our company’s General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases.
- Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology.
- Come join our team and make a meaningful impact on patients’ lives.
- Our company is a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.
- A high level of initiative, energy and motivation are key role requirements, as well as organizational skills.
- The IT-CSV Consultant will focus on validation activities for automation, Manufacturing, Enterprise and Lab Computer Systems
- Responsible for validating, at a minimum new or changes to Automation systems (e.g. Delta V), Enterprise Systems (e.g. LIMS, CMMS, HPQC, Empower), Laboratory Equipment (e.g. TOC, UV-Vis, HPLC), Data Historian (OSI Pi).
- Coordinating and monitoring the validation phases and informing management of project progress.
- Assess systems to determine validation and data integrity requirements.
- Develops and executes all validation project deliverables. Capable of owning issues and driving them to resolution.
- Capable leading testing efforts for small to medium sized projects. Interacts directly with project teams.
- Generating Validation/SDLC documentation e.g. VRQ, SRA, VP, URS, FRS, IQ, OQ, PQ, DIA, RTM, VSR.
- Creating and executing protocol test scripts in accordance with cGMP, regulatory requirements, the Computer System Validation Master/Project Plan, and Policies, Procedures & Guidelines.
- BSc qualification (Degree) in a scientific, technical or engineering discipline
- 5+ years of experience working with Computer Systems for pharmaceutical/Biotech manufacturing facilities.
- Must possess a thorough understanding of GxPs, in addition to FDA and International requirements for computer validation and Part 11 / Annex 11 requirements.
- Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Project)
- Experience with HP Application Lifecycle Management (ALM) or equivalent software testing/requirement tools