Laboratory IT QC Specialist
Hyde Engineering + Consulting
Ensures quality, compliance and reliability of laboratory IT systems through validation and support.
15 days ago ago
$90 - $100
Intermediate (4-7 years), Expert & Leadership (13+ years), Experienced (8-12 years)
Full Time
Louisville, CO
Onsite
Company Size
250 Employees
Service Specialisms
Engineering
Consulting
Project Management
Design
Technical Services
Sector Specialisms
Pharmaceutical
Biopharmaceutical
Vaccine Manufacturing
Fill-finish Facilities
Process System Design
Commissioning
Qualification and Validation
Sanitary Design
Role
What you would be doing
server monitoring
gxp administration
vulnerability testing
it qa
automation
validation docs
- Manages server and cloud monitoring, software updates, licensing, and IT budget tracking.
- Administers and supports GxP systems such as LIMS, NuGenesis, ELN, QMS, Deltek, Microsoft Office/SharePoint, and electronic signature platforms.
- Conducts vulnerability assessments/penetration tests and manages remediation activities.
- Leads GxP IT QA activities in alignment with laboratory validation plans and regulatory requirements (cGxPs, GAMP 5, 21 CFR Part 11, EU Annex 11).
- Provides in-person troubleshooting for lab hardware (PCs, analyzers, access issues, resets).
- Supports inspections and audits related to validated laboratory systems.
- Oversees onboarding/offboarding for systems, hardware, and facility access.
- Supports automation and reporting tools such as PowerApps and Power BI.
- Drafts, reviews, and approves Validation Life Cycle (VLC) documentation, test scripts, and deviations.
- Contributes to quality programs including Data Integrity, Training, Deviations, and Change Control.
- Adheres to all laboratory and safety policies and procedures.
- Maintains IT and lab policies and procedures, including cybersecurity, patch management, and system administration.
What you bring
gmp
sharepoint
hardware
bachelor's
5 years
validation
- Strong organizational skills with the ability to manage multiple projects concurrently.
- Strong knowledge of GMP, GLP, FDA regulations, 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity requirements.
- Ability to work both independently and in a team environment.
- Hands-on IT skills including hardware troubleshooting, Microsoft Office, SharePoint, and laboratory informatics systems.
- Bachelor’s degree in a science or technical field, or equivalent experience.
- Minimum of 5 years of IT and/or QC experience in regulated industries (pharma, biotech).
- Experience with validation lifecycle documentation, risk management (ICH Q9), and GxP systems.
- Excellent analytical, interpersonal, and communication skills.
Information not given or found
Training + DevelopmentInformation not given or found
Interview process
Information not given or found
Visa SponsorshipInformation not given or found
Security clearanceInformation not given or found
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Company
Overview
Founded 1993
Company Origin
The firm was established in 1993 as a boutique engineering consultancy.
2001 Global Expansion
Growth Milestone
The company expanded its operations globally, opening offices across three continents.
Revenue Millions
Financial Growth
Revenue has grown into the tens of millions, reflecting stable growth as a mid-market firm.
2020 Leadership
Succession Milestone
Key leadership transition occurred in 2020 with Kerren Bergman becoming president.
- Began as a niche engineering consultancy focused on biopharma.
- Operates 11 offices across North America, Europe, and Asia.
- Primary focus areas include process system design, commissioning & validation, FDA compliance, and cleaning technologies.
- Significant projects involve pharmaceutical manufacturing facilities, bioprocess plants, and clean utility systems.
- Maintains a global presence while providing local engineering expertise.
- Employee-owned through an ESOP since 2017, aligning staff incentives with company performance.
- Safety is always the first priority
- Our people are our greatest asset
- Collaboration and innovation drive our success
- Integrity and transparency guide our actions
- Sustainable solutions are at the core of our work
- We are committed to continuous learning and improvement
Net Zero by 2040
Carbon Emissions Target
Commitment to achieving zero net carbon emissions by the year 2040.
- Provide sustainable engineering solutions to reduce environmental impact.
- Implementation of energy-efficient practices and renewable energy solutions in projects.
- Reduce operational carbon footprint through waste management and energy conservation.
- actively fosters an inclusive and diverse work environment
- prioritizes gender diversity with efforts to close the gender gap in leadership positions
- focuses on equal opportunity in recruitment, development, and promotion of employees
- offers ongoing support for mentorship and career development programs aimed at underrepresented groups
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