CSV Associate

Job Introduction

Computer System Validation (CSV) Associate 

Hoddesdon

We are looking for:

An enthusiastic and detailed orientated Computer System Validation (CSV) Associate to support the technical administration of GMP informatics platforms and software for Hoddesdon Analytical and Process Chemistry laboratory employees. 

At Pharmaron we offer:

• Vibrant and dynamic employment – we are a highly specialised, growth company operating in a critical sector of the economy – our future is strong and exciting!
• Opportunities to develop your skills and yourself – our rapid growth brings greater opportunities for you to learn and grow faster!
• A great team where we all support each other – enjoy your work – after all you spend about a third of your time here!

Requirements:

• Bachelor’s or Master’s degree in Life Sciences, Computer Science, or related field.
• 0–2 years of experience working in IT or CSV support in the pharmaceutical or similar industry.
• General understanding of software development lifecycle (SDLC) and associated documentation with respect to regulatory compliance.
• Understanding of QMS, GMP, ALCOA+ and Data Integrity principles.
• Good understanding of laboratory systems, instruments, and associated software. 

• Knowledge of IT systems Client Server environment, Windows, Data communications equipment (Routers, Switches, LAN/WAN, Data Backup and Restore) would be desirable.

Key Roles and Responsibilities:

• Support R&D and QC laboratories as System Admin on 20+ systems.
• Support business critical roles as a back-up System Admin on Agilent OpenLab CDS  and Revvity Signals (E3) ELN.
• Support validation activities for COTS systems.
• Draft validation documentation (IA, URS, FS, IQ, OQ, PQ, QP, TRM, QSR, etc.).
• Perform GMP Risk & Impact Assessments and Data Integrity Risk Assessments.
• Support creation, modification and removal of user accounts.
• Collaborate with IT and QA to manage system changes, upgrades, deviations and investigations within the QMS.
• Conduct periodic reviews for active systems.
• Support decommissioning activities for systems being retired from use.
• Provide technical support for validated systems.
• Participate in internal audits and support external inspections.
• Act as a liaison between business users and IT for system-related issues.

Our Company: “We are a dynamic, fast-growing company, with an enviable reputation for leading edge science, offering contract research services to some of the world’s leading pharmaceutical companies, solving what were believed to be unsolvable scientific challenges”. 

We believe in our ability to relentlessly push forward the boundaries of scientific excellence, delivering solutions for our clients, always operating ethically and with integrity. We take pride in our professionalism and commitment to always deliver our very best work. 

We are based in Hertfordshire, in the town of Hoddesdon. The Hoddesdon campus, consisting of several purpose built scientific and administrative buildings together with a purpose-built conference area has more than 5,000 m² of premier R&D space and houses established Process Chemistry, Analytical Chemistry, Product Development and Drug Discovery teams. The Hoddesdon site has state-of-the-art Good Manufacturing Practice (GMP) standard facilities for the development of Active Pharmaceutical Ingredients (API) and Oral Solid Dose Manufacture, formulation development and process chemistry. We offer our employees a highly supportive team-focused environment, enabling them to develop and fulfil their true potential.

Reporting into the Analytical Chemistry management at the Hoddesdon site, you will be helping to  support the success of our scientific partners ultimately progressing medicines to the market.  A career at Pharmaron will give you the opportunity to gain exposure to a wide range of modern analytical and data handling software and bring your experience to enable these systems to be operated GMP compliantly. 

• We offer a competitive salary and a progressive and comprehensive suite of employee benefits.
• We offer state of the art working environment on site.
• We offer the opportunity for growth and development and will support funding for relevant training and development programmes.

Why Should You Apply?

• This is an opportunity for you to make a real impact in a highly scientific and regulated environment, demonstrate leadership, ambition and the desire to grow with the department.
• Build and shape your career in an environment that sets and commits to the highest standards of pharmaceutical development.
• To be part of a team who support each other, embrace and solve technical challenges and put excellence at the heart of all that we do.

Pharmaron is a premier R&D service company supporting the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities having established diverse drug R&D service capabilities, ranging from synthetic, medicinal, and analytical chemistry, biology, DMPK, pharmacology, drug safety assessment, radiochemistry and isotopically labelled metabolism, chemical & pharmaceutical development to clinical development.  With operations in China, US and UK staffed by over 21,000 employees, Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan, and China.