Vacancy expired!
- Serve as the principal IT business partner and systems engineer in support of Development and Quality functions.
- Manage enterprise Quality Control and Quality Assurance applications (QMS, Document Management, LIMS, ELN, etc.).
- Provide support and applications management for standalone laboratory instruments in support of both our Development and QC Laboratories.
- Guide and support computer systems compliance activities including change control and Computer Systems Validation (CSV).
- Act as an internal advisor to align processes and systems capabilities with industry best practices.
- Partner with stakeholders in the Development and Quality organizations to prioritize demand and the laboratory systems and Quality Assurance roadmaps.
- Propose innovative technology and processes based on cost-benefit analysis and the need to address key capabilities gaps.
- Moderate travel (estimated 10%) to laboratories in Woburn, MA and Overland Park, Kansas.
- Bachelor's degree or above, with preference for majors relating to chemistry, quality management, computer science or similar fields of study.
- At least three (3) years of relevant experience in the pharmaceuticals or life science industry, to include systems support of Research and Quality organizations with hands-on laboratory instrumentation experience.
- Working knowledge of GLP and GDP, including Computer Systems Validation (Part 11, Data Integrity, Predicate Rule).
- Prior hands-on experience with at least one of the following: LIMS implementation, QMS implementation, calibration management implementation, or ELN implementation.
- Demonstrated business communications, influencing, and situational awareness skills.
- Innovative and proactive mindset.
- Ability to translate complex business problems into solutions.
- Flexibility to wear several hats, ranging from strategy to hands-on systems work as needed.
- Business process design and documentation skills.
- Prior experience working in a lean IT organization where each person must apply diverse skills and take responsibility for multiple processes and systems.
- Direct experience with the following platforms: Agilent, Empower, and TrackWise QMS.
- Direct hands-on experience with standalone laboratory instrumentation systems (i.e., Mass Spec, FTIR, Plate Readers, etc.)
- Working knowledge of IT network engineering and information security principles; preference given to those with related education and certifications.
- Six Sigma Blackbelt
- Other certifications relevant to this role.
- ID: #49879852
- State: Massachusetts Woburn 01801 Woburn USA
- City: Woburn
- Salary: $140,000 - $160,000
- Job type: Permanent
- Showed: 2023-05-07
- Deadline: 2023-06-16
- Category: Et cetera