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Biotech Csv Jobs in Colorado (NOW HIRING)

Exposure to CSV/MES/DCS/PCS/SCADA/PLC/LIMS/EBR/QMS/PDH * Tools: Agile PLM, MS Project/Smartsheet ... Knowledge of data integrity and 21CFR11 requirements and for the design qualification of Biotech ...

Biotech Csv information

What is a Biotech CSV professional?

Biotech CSV (Computer System Validation) professionals are experts who ensure that computerized systems used in biotechnology and pharmaceutical industries meet regulatory requirements and function as intended. They are responsible for planning, executing, and documenting validation activities to ensure data integrity, product quality, and compliance with standards such as FDA 21 CFR Part 11. Their role is crucial in maintaining reliable and compliant technology solutions throughout the product lifecycle, helping companies avoid costly errors and regulatory penalties.

What are common challenges faced by Biotech CSV professionals when ensuring compliance with regulatory standards?

Biotech CSV (Computer System Validation) professionals often encounter challenges such as keeping pace with evolving regulatory requirements and ensuring that validation documentation is both thorough and audit-ready. Navigating the complexity of integrating new software or technologies into existing validated systems can also be demanding. Effective communication with cross-functional teams—such as quality assurance, IT, and laboratory staff—is crucial to address gaps and maintain compliance. Staying organized and proactive in risk management helps CSV professionals overcome these hurdles and support successful regulatory inspections.

What are the key skills and qualifications needed to thrive as a Biotech CSV specialist, and why are they important?

To thrive as a Biotech CSV Specialist, you need a solid understanding of computer system validation principles, regulatory compliance (such as FDA 21 CFR Part 11), and a background in life sciences or engineering. Familiarity with validation tools, quality management systems (QMS), and relevant software like TrackWise or MasterControl is crucial. Strong analytical thinking, attention to detail, and effective communication are standout soft skills in this role. These skills and qualities ensure validated systems meet regulatory standards, minimize compliance risks, and support reliable biotech research and manufacturing processes.

What are popular job titles related to Biotech Csv jobs in Colorado?

For Biotech Csv jobs in Colorado, the most frequently searched job titles are:

What cities in Colorado are hiring for Biotech Csv jobs?

Cities in Colorado with the most Biotech Csv job openings:

Sales Consultant - Cell & Gene Therapy

Denver, CO • On-site

System One Holdings, LLC
Business Consulting Services • 5 - 10K employees

$60K - $75K/yr

Full-time

Medical, Dental, Vision, Life, Retirement

Posted 21 days ago


Job description

Title: Sales Consultant, Cell and Gene Therapy - Welders
Location: Headquarters Lakewood, CO, remote/field-based anywhere within U.S. territory)
Type: Direct Hire
Compensation: $$68,200.00 to $75,000 plus commission
Travel: ~30-35% (field travel)
Responsibilities:
  • Generate leads in target segments to meet/exceed sales goals; develop new business with pharma and biotech accounts.
  • Sell using a consultative approach: discovery, solution positioning, training coordination, and ongoing customer support.
  • Manage customer/account activity in the CRM (account + opportunity profiles), track pipeline progress/trends, and build weekly/monthly plans plus an annual territory plan.
  • Build strong cross-functional partnerships internally to support customer success (service/training/operations).

Requirements
  • 3+ years successful consultative sales experience in biotech, medical device, or adjacent technical/regulated markets (5+ preferred).
  • Strong presentation, communication, and relationship-building skills.
  • Highly organized; planning + follow-through discipline.
  • Valid driver's license.
  • Bachelor's degree (or equivalent combination of education/experience

Product provides cell & gene therapy customers with sterile, closed-processes and automation solutions that help them collect, expand, and finish therapeutic cells more consistently, safely, and at scale.
Typical customer segments include:
  • Biopharma and biotech companies developing/manufacturing cell therapies (autologous and allogeneic programs)
  • CDMOs/CMOs and contract cell-processing/manufacturing organizations supporting CGT production
  • Hospitals/health systems with cellular therapy programs and in-house processing
  • Academic / research centers and translational labs (cellandgene.com)

Typical buyer / decision-maker personas
  • Common buyers and influencers for sterile welding + CGT workflow equipment:
  • Manufacturing / Operations: Manufacturing Manager, MSAT leader, Operations Director
  • Process/Tech: Process Development Scientist/Engineer, Automation/Controls, Tech Transfer
  • Quality: QA Manager/Director, QC leadership (closed system, contamination control, documentation expectations)
  • Facilities / Validation: Validation/CSV, Engineering, Metrology/Calibration (equipment qualification + maintenance)
  • Procurement: Strategic Sourcing, Category Manager

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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System One logo

About System One

Sourced by ZipRecruiter

System One helps employers get work done more efficiently and economically without compromising quality. Over our 35+ year history, we've helped connect thousands of talented people with innovative companies. The excitement of a perfect fit motivates us every single day.

Industry

Business consulting services and recruiting and staffing services

Company size

5,001 - 10,000 Employees

Headquarters location

Pittsburgh, PA, US