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Biotech Software Engineer Jobs in Raleigh, NC (NOW HIRING)

... engineering drawings and technical documents, financial reports and legal documents. * Software ... biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and ...

Java Developer

Cary, NC

$47.25 - $61.25/hr

Key Responsibilities Develop, configure, and support software solutions using Java Work closely ... We look for Science - Biotechnology, Pharmaceutical Technology, Biomedical Engineering ...

Java Developer

Cary, NC · On-site

$47.25 - $61.25/hr

Key Responsibilities • Develop, configure, and support software solutions using Java • Work ... We look for Science - Biotechnology, Pharmaceutical Technology, Biomedical Engineering ...

Senior MES Engineer

Raleigh, NC · On-site

$101K - $139K/yr

... biotech, or life sciences manufacturing environments * Strong knowledge of GMP regulations, data ... The software uses pre-defined, rule-based filters which operate on fixed criteria and do not ...

Senior MES Engineer

Raleigh, NC

$101K - $139K/yr

... biotech, or life sciences manufacturing environments * Strong knowledge of GMP regulations, data ... The software uses pre‑defined, rule‑based filters which operate on fixed criteria and do not ...

... BIM software. * Provides mentorship to less experienced Mechanical Engineers and/or Designers ... Life Sciences (Pharmaceutical, Biotech, Laboratory) or Food & Beverage industry experience

... BIM software. * Provides mentorship to less experienced Mechanical Engineers and/or Designers ... Life Sciences (Pharmaceutical, Biotech, Laboratory) or Food & Beverage industry experience

... BIM software. * Provides mentorship to less experienced Mechanical Engineers and/or Designers ... Life Sciences (Pharmaceutical, Biotech, Laboratory) or Food & Beverage industry experience

... BIM software. * Provides mentorship to less experienced Mechanical Engineers and/or Designers ... Life Sciences (Pharmaceutical, Biotech, Laboratory) or Food & Beverage industry experience

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Showing results 1-20

Biotech Software Engineer information

See Raleigh, NC salary details

$61.7K

$143.4K

$199.8K

How much do biotech software engineer jobs pay per year?

As of Jun 21, 2026, the average yearly pay for biotech software engineer in Raleigh, NC is $143,397.00, according to ZipRecruiter salary data. Most workers in this role earn between $116,600.00 and $168,200.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in the Biotech Software Engineer position, and why are they important?

To thrive as a Biotech Software Engineer, you need a solid background in computer science or software engineering, coupled with an understanding of biology, genetics, or related life sciences. Familiarity with programming languages such as Python or Java, experience using bioinformatics tools (like BLAST or Bioconductor), and, in some settings, knowledge of regulatory standards are highly valuable. Strong problem-solving abilities, effective communication, and the ability to work well in interdisciplinary teams distinguish top performers in this field. These skills are crucial for building reliable software solutions that support scientific discovery and innovation in biotechnology organizations.

What are some typical projects or daily tasks for a Biotech Software Engineer?

As a Biotech Software Engineer, you'll often develop and maintain software tools for analyzing biological data, automate laboratory workflows, or create user-friendly interfaces for scientific researchers. Your daily tasks might include writing code, troubleshooting algorithms, reviewing scientific data, and collaborating closely with biologists, data scientists, and laboratory technicians. Depending on the company, you may be involved in developing cloud-based platforms, integrating new laboratory hardware, or ensuring software compliance with industry regulations. This dynamic and collaborative environment means your work directly impacts ongoing research and helps accelerate scientific discoveries in the biotech sector.

What is a Biotech Software Engineer job?

A Biotech Software Engineer develops software solutions for the biotechnology industry, enabling research, data analysis, and automation in fields like genomics, bioinformatics, and drug discovery. They work with scientists to design algorithms, manage biological data, and create applications that support experiments and workflows. This role requires expertise in programming, cloud computing, and biological sciences to bridge the gap between technology and life sciences.

What are the most commonly searched types of Biotech Software Engineer jobs in Raleigh, NC? The most popular types of Biotech Software Engineer jobs in Raleigh, NC are:
What are popular job titles related to Biotech Software Engineer jobs in Raleigh, NC? For Biotech Software Engineer jobs in Raleigh, NC, the most frequently searched job titles are:
What job categories do people searching Biotech Software Engineer jobs in Raleigh, NC look for? The top searched job categories for Biotech Software Engineer jobs in Raleigh, NC are:
What cities near Raleigh, NC are hiring for Biotech Software Engineer jobs? Cities near Raleigh, NC with the most Biotech Software Engineer job openings:
Infographic showing various Biotech Software Engineer job openings in Raleigh, NC as of June 2026, with employment types broken down into 75% Full Time, and 25% Contract. Highlights an 100% In-person job distribution, with an average salary of $143,397 per year, or $68.9 per hour.
Project Manager - Senior CQV Pharmaceutical

Project Manager - Senior CQV Pharmaceutical

Visium Resources, Inc.

Raleigh, NC • On-site

Contractor

Posted 4 days ago


Job description

Introduction
Visium Resources has been asked to identify qualified candidates for a full time position as a Senior CQV Project Manager located in Raleigh, NC. We are seeking an experienced Senior CQV Project Manager to lead commissioning, qualification, and validation activities for pharmaceutical manufacturing capital projects and operational initiatives. This individual will oversee cross-functional CQV execution for GMP-regulated facilities, utilities, equipment, automation systems, and manufacturing processes while ensuring compliance with FDA, cGMP, and global regulatory standards.


The ideal candidate will possess strong pharmaceutical project leadership experience within biotech, sterile manufacturing, fill-finish, API, or biologics environments and will serve as a key liaison between engineering, quality, validation, manufacturing, and external vendors. This role requires the ability to manage project schedules, budgets, risks, resources, and validation deliverables in support of facility expansions, new product introductions, and operational readiness initiatives.


Key Success Criteria
  • Experience leading major expansion C&Q projects start to finish (brownfield or greenfield). From strategy / planning through to full doc prep & execution
  • Writes CQV Strategies & Plans.
  • CQV Schedule
  • Should have experience with C&Q of process equipment.
  • Has experienced with integrated CQV (ASTM E2500 and ISPE C&Q baseline guide)
  • Has experience with digital validation (i.e. Kneat or other software) is a major asset but not required.
  • Capital Improvements experience is a major asset but not required.

Key Responsibilities
  • Lead all CQV project activities for pharmaceutical and biotech manufacturing projects. 
  • Develop and manage CQV strategies, project plans, schedules, budgets, and resource allocation. 
  • Coordinate commissioning and qualification activities for: 
    • Process equipment 
    • Clean utilities 
    • HVAC systems 
    • Automation and control systems 
    • Manufacturing and packaging lines 
  • Ensure compliance with FDA, cGMP, ISPE, GAMP, and corporate quality standards. 
  • Oversee execution of: 
    • FAT/SAT protocols 
    • IQ/OQ/PQ protocols 
    • Validation documentation 
    • Deviations and CAPAs 
    • Change controls 
  • Collaborate with Quality Assurance, Engineering, Manufacturing, Automation, and Regulatory teams to support project milestones and inspection readiness. 
  • Manage third-party CQV consultants, contractors, and vendors. 
  • Provide risk assessments and mitigation strategies to maintain project timelines and compliance objectives. 
  • Support startup, operational readiness, and technology transfer activities. 
  • Present project status updates and KPI reporting to senior leadership and stakeholders.

Qualified candidates would have the following:

  • Minimum 8-12 years of experience in pharmaceutical, biotech, or life sciences industries. 
  • Minimum 5 years of direct CQV project management experience within GMP-regulated manufacturing environments. 
  • Proven experience managing large-scale capital projects, facility expansions, or greenfield startup projects. 
  • Strong experience with commissioning and qualification of: 
    • Cleanrooms 
    • Process equipment 
    • Utilities 
    • Automation systems 
    • Manufacturing processes 
  • Experience authoring and reviewing validation lifecycle documentation. 
  • Demonstrated success leading cross-functional teams and managing multiple project workstreams simultaneously. 
  • Experience supporting FDA audits and regulatory inspections. 
  • Background in biologics, sterile fill-finish, vaccine, API, or aseptic manufacturing environments strongly preferred. 

Required Qualifications
  • Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related technical discipline. 
  • Strong understanding of: 
    • cGMP regulations 
    • FDA validation requirements 
    • ISPE Baseline Guides (inc. C&Q) and ASTM E2500 GUIDE
    • GAMP 5 principles 
  • Proficiency with project management methodologies, scheduling tools, and reporting systems. 
  • Excellent communication, leadership, and stakeholder management skills. 
  • Ability to work effectively in fast-paced, highly regulated project environments. 

Preferred Qualifications
  • Digital Validation software experience (i.e. Kneat or equivalent)
  • PMP certification preferred. 
  • Experience with DeltaV, MES, SCADA, or other pharmaceutical automation platforms. 
  • Familiarity with Kneat, TrackWise, Veeva, or electronic validation systems. 
  • Previous consulting or EPCM experience is a plus. 
  • Lean Six Sigma certification preferred.

________________________________________________________________________________________________


Visium Resources is an award-winning employment firm with a mission to match talented individuals with highly successful organizations. At Visium, our company's success is based on your success. When you work with us, you are never 'just a number'. You are our most important asset. Here, you will know us by name through our regular visits to client sites and even occasional luncheons. We will always be there when you need assistance and will always go the extra mile to ensure that you are as successful as possible. Whether you're looking for contract, contract-to-hire or permanent opportunities, we firmly believe there is no employment agency that will work harder for you than Visium.
Visium Resources is an equal opportunity employer and values diversity. All employment is decided based on qualifications, merit and business need.

Education:BS/BA DegreeEmployment Type: CONTRACTOR