CSS L2

DescriptionCompliance Solution Specialist (CSS, Levels 1 through 4)
Reports to: Team Lead
Department: Compliance Solution - Field Operations
Location Region-based; field and customer-site work
Direct reports: None at L1 and L2; L3 and L4 mentor and review the work of more junior CSS
Travel: Local to national
Position Summary
The Compliance Solution Specialist (CSS) is the technical professional who delivers compliance services at customer sites across the VaLogic Bio service lines: Validation (including Computer System Validation), Calibration, Certification, Lab Services, Maintenance, and Strategic Consulting (regulatory advisory). The CSS career ladder runs L1 through L4.

Key responsibilities

• Execute compliance services independently within 2 of the service lines (validation, calibration, environmental monitoring, clean environment certification, lab support activities, preventive and corrective maintenance) per VaLogic Bio SOPs and customer requirements.
• Maintain accurate, contemporaneous, attributable, legible, and original documentation that meets ALCOA+ data integrity standards.
• Communicate professionally and clearly with customer personnel on site; escalate appropriately.
• Identify and report compliance risks, deviations, and out-of-specification results promptly.
• Complete required training and competency assessments on schedule.

Required qualifications

• Education and experience appropriate to the entry level (see the Leveling Matrix; L1 entry: High School or equivalent plus technical training or an AS;
• Working knowledge of GxP and data integrity principles, with depth scaled to level.
• Excellent attention to detail; reliable execution of structured technical work.
• Professional written and verbal communication.
• Ability to travel to customer sites and to maintain a customer-ready professional presence.

Preferred qualifications

• Prior experience in pharmaceutical, biotech, medical device, or other regulated manufacturing.
• Industry certifications appropriate to the candidate's level and specialty (e.g., NEBB CPT for certification, ASQ CQE for quality, ISPE GAMP for CSV).

Working conditions
Field-based role with significant customer-site work. Travel at all level, from primarily local to regional and occasionally national. Physical demands include standing, walking, climbing ladders, accessing equipment, and wearing PPE as required by customer sites.

Benefits

We currently offer a robust suite of employee benefits including:

Medical & Prescription Coverage Supplemental Life and AD&D
Dental Coverage Short and Long term Disability
Vision Coverage Employee Assistance Program
Health Savings Account (HSA) Unlimited Paid Time Off
Basic Life and AD&D 11 Paid Company Holidays

EEO Statement

VaLogic Bio, LLC is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

VaLogic Bio, LLC (VaLogic) does not accept unsolicited resumes from search firms or any other third parties. Any unsolicited resume sent to VaLogic will be considered VaLogic property, and VaLogic will not pay a fee should it hire the subject of any unsolicited resume.