Senior Computer System Validation (CSV) Engineer

Company Description

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.

Senior Computer System Validation (CSV) Engineer

The Senior Computer System Validation (CSV) Engineer will be responsible for Validation of Computer Systems throughout the System Lifecycle. This role will be part of the IT Clinical Development Systems team and reports to Sr Director IT Clinical Data Systems.

About You

You will be a part of interdisciplinary team including Clinical Development, Quality & IT to spearhead the validation of IT systems being implemented to support drug development program and computer system validation is second nature to you.  You’re conscientious and pay attention to detail.  You’re a problem solver and work well with a cross functional team.  You thrive in a fast-paced environment and are a multitasker.  You’re resourceful and work independently.

What You’ll Do

• Responsible for Computer System Validation of GxP Systems.
• Work with Business, Quality and Vendor teams to develop and facilitate approval of Validation documentation including:
• Validation Plan and Summary Reports
• Protocols – IQ/OQ/PQ and UAT Scripts
• User and Functional Requirements, Design and Configuration Specification, Business Process Flow Documents
• Risk Assessments and Traceability Matrix
• Qualification script execution and review against acceptance criteria
• Application Training, SOP and Work Instruction (WI) documentation
• Plan and Execute of Validation and Qualification scripts & activities and review against acceptance criteria.
• Management of UAT with End Users including planning, execution, and review of executed scripts.
• System Change Control Management ensuring systems remain GxP compliant.
• System Support for End Users as needed.
• System Setup & Maintenance including User Setup, Configuration Changes as needed.
• Support the development and maintenance of CSV SOPs including System Validation, Change Control, Risk Management, SDLC.

Qualifications

• BS/BA degree in engineering, computer science, information systems or equivalent with a combination of education/work experience
• 6+ years of Computer System Validation experience with full lifecycle validation of multiple computer systems (e.g. eTMF, CTMS, EDMS, QMS, Training)
• 4+ years’ experience with major computer systems such as Medidata, Oracle, Veeva.
• Solid knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Annex 11, GAMP5 and GxP guidelines.
• Detail Oriented; Excellent written and verbal communication skills.
• Proven skills in relationship building, customer-focus, decision-making, and problem solving.
• Ability to quickly understand business process and flows in unfamiliar functional areas to develop validation documentation and complete system validation.
• Experience with validation of systems in Clinical and Quality business functions is desirable. 

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

• 401k plan with company matching​
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)​
• Mental health and wellness benefits​
• Weeklong summer and winter holiday shutdowns​
• Generous paid time off and holiday policies​
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies ​
• Enhanced parental leave benefit​
• Daily subsidized lunch program when on-site​

The expected salary range for this role is $100,000 to $115,000, depending on skills, competency and the market demand for your expertise.