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Biotech Csv Jobs in Georgia (NOW HIRING)

CSV Lead

Atlanta, GA · On-site

$98K - $129K/yr

CSV Lead -- East Coast (Greenfield Pharma/Biotech Program) About the Role We're seeking a CSV (Computer System Validation) Lead to support automation and digital systems validation on a major ...

New

CSV Quality Engineer Lead- Part-Time Location: Remote Commitment: Approximately 20 hours per week ... At least 7 years of Quality experience in pharmaceutical, biotechnology, life-sciences technology ...

Senior MES MBR Author

Atlanta, GA · On-site

$125 - $150/hr

Experience supporting pharmaceutical, biotechnology, vaccine, cell therapy, gene therapy, or other regulated manufacturing operations. * Knowledge of Computer System Validation (CSV), qualification ...

... Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory ... FAT, SAT, CSV, equipment integration, and startup. * Drive process design for new equipment and ...

Strong CSV management and deliverable governance experience * Background in document review, resource planning, and quality systems oversight * Experience on large capital pharma/biotech or advanced ...

New

Automation Program Lead -- East Coast (Greenfield Pharma/Biotech Program) About the Role Join a ... Own Automation Governance, Digital Systems Integration, MES/EBR Governance, CSV Coordination, and ...

New

Ensure all automation systems comply with GMP, FDA regulations, Computer System Validation (CSV ... Proven experience in GMP-regulated operations such as pharmaceutical, biotechnology, medical device ...

Collaborate with scientists, QA/CSV teams, and IT to gather requirements, design technical ... Experience working in regulated environments such as pharmaceuticals, biotechnology, or food safety

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 Georgia?

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

CSV Lead

Valspec

Atlanta, GA • On-site

$98K - $129K/yr

Full-time

Medical, Retirement

Posted 3 days ago

New


Job description

Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec's mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals.

Valspec's projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.

CSV Lead — East Coast (Greenfield Pharma/Biotech Program)

About the Role
We're seeking a CSV (Computer System Validation) Lead to support automation and digital systems validation on a major greenfield pharmaceutical manufacturing program.

What You'll Do

  • Manage CSV execution and deliverable governance
  • Coordinate with the Automation Program Lead on MES/EBR and digital systems validation
  • Support qualification documentation and execution team management

What We're Looking For

  • Greenfield CSV leadership experience
  • Strong deliverable governance and execution team management background
  • Familiarity with IQ/OQ/PQ and GMP qualification workflows

Location: East Coast (site-specific details shared during interview process)

Why Join Valspec?

At Valspec, we offer more than just a job — we provide a career experience rooted in a standout culture, collaborative environment, and a strong sense of ownership. As an Employee Stock Ownership Plan (ESOP) company, every team member has a stake in our success, fostering a shared commitment to excellence and innovation.  We also offer a highly competitive benefits package, including:

  • Premium medical coverage
  • 401(k) with company match
  • Tuition reimbursement
  • Unique performance incentives
  • And more — all designed to support your growth, well-being, and future.

Join a team where your contributions matter, your development is prioritized, and your success is shared.

When receiving e-mails from a Proconex or Valspec recruiter, you will only receive e-mails from addresses ending in @proconexdirect.com, @proconex.net or @valspec.net.  Any other domains are impersonations and should be ignored.

Candidates must be legally eligible to work in the United States without company sponsorship.  Also, we are not interested in working on a corp-to-corp basis with other companies at this time.

Any third-party unsolicited resume submission(s) will immediately become the property of Valspec. Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.

Valspec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.