Lab Systems Engineer in Devens, MA at Integrated Resources, Inc

Date Posted: 11/12/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Devens, MA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    11/12/2019

Job Description

Qualifications:

1. A successful candidate will possess a minimum of a Bachelor's degree in a Computer Science, Engineering, Science or equivalent field with at least 3 years of experience within a GxP environment at a pharmaceutical / Biotechnology industry.
2. Experience and knowledge of GMP, 21CFR Part 11, excellent written and verbal communication skills, and strong adherence to Good Documentation Practices.
3. A successful candidate will possess:
a. Ability to identify data integrity/compliance gaps and create remediations with minimal supervision
b. Ability to gain technical understanding via SOPs and manuals
c. Experience with ticketing and change management systems (Vitalize and Trackwise experience are a plus).
d. Have knowledge of laboratory software technologies with the ability to assess issues and mitigate utilizing the appropriate change control process. Benchtop equipment includes, but is not limited to: ViCell, HIAC, UV-VIS, SoftMax plate readers, cIEF, etc.
e. Experience and/or substantial understanding of Lab system principles and common system vendors' available products with the ability to engage the vendor for additional support when required.
f. Knowledge and experience administrating systems per defined SOPs: Lab Execution System (SmartLab), Empower, NuGenesis, Trackwise, Document Management System (DCA) is strongly encouraged.
g. Skills and experience working in diverse, multi-disciplined work groups, able to prioritize and allocate their time to meet the business day-to-day demands in a fast paced environment.
h. Engaged hands-on individuals that have the ability to self-direct and take initiative when an opportunity arises that requires attention and support.

4. Additional skills of experience with Windows 7/10 PC configuration, HPALM, Crystal Reports, SQL Reports, and html expertise may be useful but are not required.