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Aseptic Process Engineer Jobs in Raleigh, NC (NOW HIRING)

Novartis

Aseptic Drug Product MS&T Lead

Durham, NC · On-site

$138K - $257K/yr

As the Aseptic Drug Product MS&T Lead, you will play a critical leadership role at our Durham site ... You will lead a talented team of scientists and engineers, oversee process validation and ...

ATS Automation

Senior Systems Engineer

Raleigh, NC

$145K - $175K/yr

In this role, you'll be the technical glue across mechanical design, controls, automation, process ... Direct experience with aseptic fill-finish and/or lyophilization systems. * Working knowledge of ...

Kelly Services

Sterility Assurance Lead

Raleigh, NC

$90K - $110K/yr

Provide oversight for terminal sterilization and aseptic manufacturing processes across development ... Partner with Manufacturing, Engineering, Validation, Quality Control Microbiology, and Quality ...

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Aseptic Process Engineer information

See Raleigh, NC salary details

$48.1K

$89.4K

$138.5K

How much do aseptic process engineer jobs pay per year?

As of Aug 12, 2026, the average yearly pay for aseptic process engineer in Raleigh, NC is $89,449.00, according to ZipRecruiter salary data. Most workers in this role earn between $72,400.00 and $100,100.00 per year, depending on experience, location, and employer.

What is an aseptic process engineer?

Aseptic process engineers are professionals who design, develop, and maintain sterile manufacturing systems, primarily in the pharmaceutical, biotechnology, and food industries. Their main responsibility is to ensure that products are produced in a contamination-free environment, using processes that prevent the introduction of microorganisms. This involves overseeing the design of cleanrooms, validating equipment, developing standard operating procedures, and ensuring regulatory compliance. Aseptic process engineers work closely with quality assurance teams to maintain high standards of product safety and efficacy. Their expertise is crucial for industries where product sterility is critical to consumer safety.

What are some common challenges faced by aseptic process engineers, and how can they be addressed?

Aseptic Process Engineers often encounter challenges such as maintaining strict sterility standards, troubleshooting equipment issues, and ensuring compliance with changing regulatory requirements. Addressing these challenges requires strong attention to detail, proactive communication with cross-functional teams, and staying current with industry best practices and regulations. Collaborating closely with quality assurance, production, and maintenance teams helps to identify and resolve issues quickly, ensuring that processes remain efficient and compliant.

What is the difference between Aseptic Process Engineer vs Pharmaceutical Manufacturing Technician?

AspectAseptic Process EngineerPharmaceutical Manufacturing Technician
CredentialsBachelor's degree in engineering, life sciences, or related field; GMP trainingHigh school diploma or associate degree; GMP training often required
Work EnvironmentCleanroom, sterile environments, manufacturing facilitiesManufacturing floors, production areas, sometimes cleanrooms
Industry UsageDesign, optimize, and validate aseptic processes in pharmaOperate equipment, assemble products, support manufacturing

The Aseptic Process Engineer focuses on designing and validating sterile manufacturing processes, requiring specialized engineering knowledge. In contrast, the Pharmaceutical Manufacturing Technician handles day-to-day production tasks, often with less formal education but essential for maintaining manufacturing flow. Both roles are vital in pharmaceutical production but differ in responsibilities and qualifications.

What are the key skills and qualifications needed to thrive as an aseptic process engineer, and why are they important?

Aseptic Process Engineers need a strong background in chemical, mechanical, or biomedical engineering, along with experience in aseptic manufacturing environments and a solid understanding of GMP regulations. Familiarity with process automation systems, sterilization equipment, and industry certifications such as Six Sigma or Lean Manufacturing are often required. Attention to detail, strong problem-solving abilities, and effective communication are vital soft skills for ensuring product quality and process efficiency. These skills are crucial for maintaining sterile conditions, regulatory compliance, and the safe production of pharmaceuticals or biotechnology products.
What are popular job titles related to Aseptic Process Engineer jobs in Raleigh, NC? For Aseptic Process Engineer jobs in Raleigh, NC, the most frequently searched job titles are:
What job categories do people searching Aseptic Process Engineer jobs in Raleigh, NC look for? The top searched job categories for Aseptic Process Engineer jobs in Raleigh, NC are:
What cities near Raleigh, NC are hiring for Aseptic Process Engineer jobs? Cities near Raleigh, NC with the most Aseptic Process Engineer job openings:
Aseptic Process Engineer jobs near you

Staff Engineer - Process & Cleaning Validation

PM Group

Zebulon, NC • On-site

Contractor

Re-posted 8 days ago

Job description

Overview
The Staff Engineer - Process & Cleaning Validation position is an exciting opportunity to join PM Group's quickly growing Outsourced Technical Services(OTS) team near Zebulon, NC. Outsourced Technical Services (OTS) is an integral part of PM Group's ability to support clients across the complete project life cycle. We have over 50 years' industry experience, strong technical knowledge and integrated resources. Clients look to us to provide experienced technical professionals that complement their project teams. Together we are sharing knowledge, learning, growing and continuing to be an integral part of supporting PM Group's ongoing expansion in the US.
We are seeking an experienced Staff Engineer, Process & Cleaning Validation to support manufacturing operations by ensuring processes and cleaning procedures are validated, compliant, and capable of consistently delivering high-quality products in a regulated sterile/aseptic environment.
PM Group is an employee owned, international project delivery firm with a team of 4,000+ people. We are world leaders in the pharma, food, biotech, medical technology and mission critical sectors. From our network of offices in Europe, Asia and the US, we work with the world's leading organizations. We are focused on growing a sustainable business centered on our people, our clients and trade partners.
Responsibilities
  • Lead process validation (PPQ) and cleaning validation activities.
  • Develop validation strategies for new and existing products, processes, and equipment.
  • Author, review, and execute validation protocols and reports.
  • Analyze data and compile conclusions to support validation activities.
  • Support change controls, deviation investigations, and CAPA initiatives.
  • Collaborate with cross-functional teams including Manufacturing, Quality, and Technical Operations.
  • Ensure compliance with cGMP requirements and regulatory expectations.
  • Participate in internal and external audits and regulatory inspections.
  • Drive continuous improvement initiatives related to validation programs.

Qualifications
  • Bachelor's degree in Engineering, Chemistry, Life Sciences, or a related technical discipline.

  • 8+ years of experience in process validation and/or cleaning validation within a regulated manufacturing environment.

  • Hands-on experience in sterile or aseptic manufacturing environments is required.
  • Strong knowledge of cleaning validation principles, including residue limits, risk assessments, and risk-based validation approaches.
  • Experience with lifecycle process validation and Process Performance Qualification (PPQ).
  • Strong understanding of cGMP regulations and industry standards.
  • Excellent analytical, problem-solving, and data interpretation skills.
  • Proven technical writing and documentation experience.
  • Ability to manage multiple priorities and projects simultaneously.
  • Strong communication and cross-functional collaboration abilities.
  • Demonstrated attention to detail and commitment to quality and compliance.

All of your information is confidential according to EEO guidelines.
Why PM Group?
As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are the heart of our new 2026 business strategy. Click here to read more in our 2025 Environmental, Social and Governance Report.
Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future.
PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know.
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