1mo
Save
Mark Applied
Hide
CSV Specialist II
Durham, North Carolina, United States
OnsiteFull Time
3+ YOEBachelor's in engineering/IT, 3+ years CSV experience in pharma/biotech, GAMP and 21 CFR Part 11 expertise, validation documentation and testing, and proficiency with Microsoft Excel and electronic document management systems.
GAMP, 21 CFR Part 11, Microsoft Office, Microsoft Excel, electronic document management systems
1mo
Save
Mark Applied
Hide
6385- Senior CSV/CQV Engineer / Senior Validation Engineer 2
Durham or Fishers
$65k-$91k/yr OnsiteFull Time
5+ YOEBachelor's degree required; 5+ years CSV experience in GMP pharmaceutical/biotech; PLC/HMI and historian validation experience; PAT instrument integration experience preferred; ability to author CSV deliverables and perform data integrity assessments; must be local to RTP and work onsite 100%.
PLC, HMI, PAT, NIR, NTP, Historian
4w
Save
Mark Applied
Hide
Project Manager – North Carolina
Raleigh or Durham or North Carolina
OnsiteFull Time
5+ YOE5+ years CQV/validation project management experience in GMP environments; strong IQ/OQ/PQ knowledge; experience with process equipment, utilities, and facility systems; able to lead on-site CQV execution and cross-functional teams. CSV/MES exposure preferred.
CSV, MES
3mo
Save
Mark Applied
Hide
Delivery Engineer
Durham, North Carolina, United States
OnsiteFull Time
Proficient in Python for data manipulation and automation; healthcare data experience; Excel/CSV and basic SQL; strong communication and project management; self-starter in a fast-paced environment.
Python, SQL, pandas, requests
1mo
Save
Mark Applied
Hide
Manager, Laboratory Automation & AI Transformation Lab
Durham, North Carolina, United States
$80k-$167k/yr OnsiteFull Time
5+ YOEBachelor's in science/engineering, 5+ years in lab operations or automation, experience with LIMS/ELN and instrument integration, familiarity with validation/CSV and regulated lab requirements, leadership and change management skills.
LIMS, ELN
2mo
Save
Mark Applied
Hide
Sr/Principle Computer Systems Validation Specialist
Durham, North Carolina, United States
$118k-$184k/yr OnsiteFull Time
8+ YOESenior/Principal level CSV expertise in cGMP, data integrity, 21 CFR Part 11, FDA-regulated manufacturing; 8+ to 15+ years experience; based in NC; GMP compliance knowledge.