Business Analyst 2, BioAnalytical Sciences Information Systems

Location:  San Rafael, California Category: Research

Description

DESCRIPTION

BioMarin 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 teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.

SUMMARY

As a member of the BioAnalytical Operations-Information Systems (BAO-IS) team in the BioAnalytical Sciences (BAS) Department, you will play a key role in system deployment, validation and business process development. You will have the opportunity to participate in high impact, high visibility projects such as automated data capture and analysis, digital transformation of existing business process, and critical laboratory systems validation supporting GxP and R&D laboratory workflows. We are looking for an outgoing, motivated individual who is excited at the prospect of building out new digital infrastructure and taking it from concept through validation and finally deployment to a dynamic team of industry-leading scientific staff.

 

RESPONSIBILITIES

  • Perform drafting of project implementation plans, requirement specifications, and execution of test scripts for system validation implementation projects according to applicable GLP and 21CFR11 compliance regulations.
  • Assume Business Process Owner and Subject Matter Expert roles for system validation implementation projects.
  • Prepare controlled documents, process documents, and data reports including but not limited to SOPs, System Design Documents, System Configuration Documents, Data Transfer Specifications.
  • Perform System Administration and configurations as well as resolve technical issues for BAS Enterprise systems (such as LIMS, ELN, and SDMS), analytical instruments, and other software.
  • Perform Super User functions for BioMarin information and file sharing systems related to BAS.
  • Perform and assist with tasks for implementation and/or validation of new instrument and computer systems, software, and upgrades.
  • Business Process expert for 1 or more GxP validated systems in BAS.
  • Involved in decision making processes for the purchase of new systems.
  • Prepare controlled documents, process documents, and data reports including but not limited to SOPs, System Design Documents, System Configuration Documents, Data Transfer Specifications.
  • Collaborate with BAS Managers and Scientists to improve workflow processes involving LIMS and other computer systems.
  • Collaborate with BAS Managers to develop management metrics derived from computer system usage.
  • Coordinate with BAS personnel for instrument workstation troubleshooting and maintenance.
  • Provide general training on computer systems as needed.
  • Ensure data integrity and compliant laboratory operations.
  • Participate in internal and external inspections and audits.
  • Other duties as assigned

 

EXPERIENCE

  • Required: At least 4 years of experience as a Network or Laboratory Information Systems (LIMS, ELN, LES, etc.) Administrator.
  • Required: Strong technical skills in troubleshooting various computer systems/software and advanced MS Office, Excel skills.
  • Required: Excellent writing and verbal communications skills.
  • Preferred: At least 2 years of experience working in a bioanalytical laboratory or 2 years working in a biopharmaceutical company.
  • Preferred: Experience with 21 CFR Part 11Good Documentation Practices and Data Integrity Compliance.  SQL skills a plus.

 

EDUCATION

  • Required: Bachelor’s degree in computer sciences or equivalent experience with administration of information systems, laboratory information systems; or similar integrated, networked computerized systems; or Clinical Laboratory Scientist with laboratory information systems administrator experiences.
  • Preferred: Master’s degree in computer sciences

 

 

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.