ZipRecruiter

Log In

1

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

Novartis

Engineer, MS&T - Aseptic Drug Product

Durham, NC · On-site

$89K - $166K/yr

Summary Are you passionate about advancing sterile manufacturing processes that help deliver life-changing therapies to patients? As an Engineer, Manufacturing Science & Technology (MS&T) - Aseptic ...

Valspec

Process Validation Engineer

Raleigh, NC

Process Engineer (Process Validation / PPQ Readiness) Location: Sanford, NC (Onsite) Type: Contract ... Familiarity with airflow visualization (AFV) studies within aseptic manufacturing environments.

Valspec

Process Validation Engineer

Durham, NC

Process Engineer (Process Validation / PPQ Readiness) Location: Sanford, NC (Onsite) Type: Contract ... Familiarity with airflow visualization (AFV) studies within aseptic manufacturing environments.

Danaher

Senior Engineer, Process Validation

Raleigh, NC · On-site +1

$100K - $130K/yr

The Senior Engineer, Process Validation is responsible for leading & supporting internal and ... for aseptic manufacturing processes including sterile filtration, aseptic process simulation ...

Danaher

Senior Engineer, Process Validation

Raleigh, NC · On-site +1

$100K - $130K/yr

The Senior Engineer, Process Validation is responsible for leading & supporting internal and ... for aseptic manufacturing processes including sterile filtration, aseptic process simulation ...

next page

Showing results 1-20

All JobsAseptic Process Engineer JobsAseptic Process Engineer Jobs in Raleigh, NC

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 Sep 2, 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 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 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 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

Engineer, MS&T - Aseptic Drug Product

Scorpion Therapeutics

Durham, NC • On-site

$90 - $166/hr

Other

Medical, Life, Retirement, PTO

Posted yesterday

New

Job description

Key Responsibilities:
  • Monitor and analyze process performance data to support continued process verification and product quality.
  • Lead technical investigations and provide scientific expertise to resolve manufacturing process challenges.
  • Trend critical quality attributes and process parameters to identify risks and drive improvements.
  • Support technology transfer activities for new products and processes into commercial manufacturing.
  • Identify and implement continuous improvement opportunities that enhance operational performance.
  • Partner with Quality teams to maintain a compliant and inspection-ready manufacturing environment.
  • Collaborate with Manufacturing to troubleshoot production issues and ensure reliable product supply.
  • Support process changes and improvements with cross-functional Engineering, Validation, and Operations teams.
  • Contribute to the startup and implementation of new equipment, software, and manufacturing processes.
  • Provide technical support for strategic projects, remediation initiatives, and process optimization efforts.
Essential Requirements:
  • Bachelor’s in Biochemistry, Chemical Engineering, Bioengineering, or related field with 4+ years biopharmaceutical GMP manufacturing (including aseptic fill-finish); or 3+ years direct Novartis Gene Therapies experience with aseptic fill-finish; or Master’s with 2+ years relevant aseptic fill-finish or engineering experience.
  • Knowledge of GMP requirements, pharmaceutical manufacturing regulations, and validation/qualification principles.
  • Experience supporting aseptic drug product manufacturing, MS&T, process engineering, or related technical operations.
  • Strong technical writing skills for accurate, compliant documentation.
  • Proven ability to collaborate across cross-functional teams and communicate with diverse stakeholders.
  • Ability to travel up to 10%.
Benefits (explicitly stated):
  • Salary expected range: $89,600–$166,400 annually; performance-based cash incentive; eligibility for annual equity awards (depending on level).
  • US-based comprehensive benefits (health, life/disability), 401(k) match, time off (vacation, personal days, holidays, other leaves).

Onsite in Durham, NC; no relocation support—apply only if location is accessible.

#J-18808-Ljbffr

Apply