This job is currently Archived,
Posted on : 08 March 2017
- 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
Duration: 6 Months
- 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
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Find a Job Find Candidates