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Drug Product Process Engineer Jobs (NOW HIRING)

FUJIFILM Biotechnologies

... process SME who keeps operations running smoothly in a 24/7 environment-driving documentation excellence, tech transfer readiness, and continuous improvement across Drug Product Finished Goods.

Alcami Corporation

Sr. Process Engineer

Charleston, SC · On-site

$99K - $128K/yr

Job Summary The Sr. Process Engineer is accountable for driving results in a fast-paced environment by providing technical support for clinical and commercial parenteral Drug Product manufacturing.

Alcami Corporation

Sr. Process Engineer

Charleston, SC · On-site

$99K - $128K/yr

The Sr. Process Engineer is accountable for driving results in a fast-paced environment by providing technical support for clinical and commercial parenteral Drug Product manufacturing. The Sr. ...

Merck & Co.

$101K - $131K/yr

We have an exciting opportunity for a Senior Process Engineer, Technical Operations - Small Molecule Drug Product (Spray Drying) to join our growing team.At our company, we aspire to be the premier ...

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Drug Product Process Engineer information

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$49.5K

$113.5K

How much do drug product process engineer jobs pay per year?

As of Sep 10, 2026, the average yearly pay for drug product process engineer in the United States is $108,847.00, according to ZipRecruiter salary data. Most workers in this role earn between $113,000.00 and $113,000.00 per year, depending on experience, location, and employer.

What does a drug product process engineer do?

A Drug Product Process Engineer is responsible for designing, optimizing, and overseeing the manufacturing processes of pharmaceutical products, such as tablets, capsules, or injectable drugs. They work to ensure that drug products are produced efficiently, safely, and in compliance with regulatory standards. Their duties often include process development, troubleshooting production issues, scaling up processes from laboratory to manufacturing scale, and collaborating with cross-functional teams such as quality assurance and research & development. By continuously improving processes, they help ensure the quality and consistency of drug products delivered to patients.

What are the key skills and qualifications needed to thrive as a drug product process engineer?

To thrive as a Drug Product Process Engineer, you need a solid background in chemical engineering, pharmaceutical sciences, or a related field, often supported by a bachelor’s or master’s degree. Familiarity with process simulation tools, Good Manufacturing Practices (GMP), and quality control systems is typically required. Strong problem-solving abilities, attention to detail, and effective communication skills set exceptional candidates apart. These capabilities are vital to ensuring safe, efficient, and compliant drug product manufacturing processes in a regulated environment.

What are some common challenges faced by drug product process engineers during scale-up from laboratory to commercial manufacturing?

One of the main challenges Drug Product Process Engineers encounter during scale-up is ensuring that product quality and consistency are maintained when moving from small-scale laboratory batches to full-scale commercial production. Variations in equipment, process parameters, and environmental factors can impact critical quality attributes, requiring careful risk assessment and validation. Engineers must collaborate closely with formulation scientists, quality assurance, and manufacturing teams to troubleshoot issues, optimize processes, and ensure regulatory compliance. Proactive communication and strong problem-solving skills are essential to overcoming these challenges and achieving successful technology transfer.

What are popular job titles related to Drug Product Process Engineer jobs?

For Drug Product Process Engineer jobs, the most frequently searched job titles are:

Bio/Sterile Drug Product Process Expert - 599833

Boston, MA • On-site

Solve IT Strategies, Inc.
Recruiting and Staffing Services • 11 - 50 employees
Learn more about Solve IT Strategies, Inc.external

Full-time

Posted 14 days ago

Key responsibilities

  • Provide day-to-day technical oversight of activities at external CMO partners involved in sterile drug product manufacturing.

  • Collaborate with cross-functional teams and external partners to drive technical investigations, change implementations, and continuous improvements.

  • Participate in process risk assessments, review manufacturing processes, and support regulatory documentation related to sterile drug products.

Job description

Role Summary

This position is a contract worker (CW) role in which the CW is a subject matter expert (SME) responsible for technical oversight of several sterile drug products at external manufacturing sites related to drug product manufacturing. This CW will work with other SMEs knowledgeable with the CMO and the sterile products.

Primary Responsibilities

  • Day-to-day technical oversight of activities at external CMO partners
  • Provide technical oversight at Drug Product CMOs within Servier External Manufacturing organization framework
  • Proactively drive technical deviation investigations, change implementations and continuous improvements in alignment with technical team and Virtual Plant Team goals
  • Collaborate efficiently with Quality, Operations, Supply Chain and extended teams
  • Maintain and review Drug Product manufacturing process monitoring for commercial products as part of robust Continuous Process Verification
    • Cross-functional team participation
    • Actively participate in Virtual Plant Team led by Operations
    • Be the Servier point of contact (with SME oversight) for Joint Technical Team responsible for coordinating with CMO point of contact to drive agenda, moderate meetings and review minutes
      • Subject Matter Expertise (SME)
      • Perform process risk assessments to define improvements and mitigate gaps as per Quality and Regulatory requirements and industry best practices
        • Familiarize with and author/review CMC related sections for regulatory filings
        • Other duties as required by management

          • Education and Required Skills

          • Minimum B.S. degree in Pharmaceutical Sciences or Chemical Engineering or related technical field with minimum of 6 years relevant experience or a M.S. degree in Pharmaceutical Sciences or Chemical Engineering with a minimum of 5 years of relevant experience in sterile drug product formulation and process development and manufacturing including experience with regulatory submissions
          • In-depth knowledge of sterile drug product formulation concepts/techniques and aseptic fill/finish processes as well as relevant GxPs and multinational regulatory guidelines
          • In-depth knowledge of container closure components as well as single-use components and technologies typically used in aseptic processing
          • Experience in a variety of problem-solving tools (e.g. Ishikawa, Kepner-Tregoe (KT), five-whys, etc.)
          • Strong analytical skills, attention to detail, and ability to plan, organize, and manage multiple projects simultaneously
          • Strong interpersonal skills and demonstrated accomplishments working in interdisciplinary teams that require collaboration, influencing and negotiation skills, and analytical judgement
          • Working knowledge in microbiology and extractables/leachables techniques and regulations
          • Experience with basic statistical methodologies and software (e.g., Minitab, JMP or equivalent)
          • Experience in collaborating with Contract Development / Manufacturing Organizations and external partners
          • Excellent written and oral communication and presentation skills

            • Travel and Location

            • Domestic travel up to 20%
            • Preferred location is in Boston, USA, but position is amenable to remote work
            Solve IT Strategies logo

            About Solve IT Strategies

            Sourced by ZipRecruiter

            We are a technology staffing firm, offering a comprehensive suite of services designed to cater to the dynamic and specialized needs of businesses in the constantly evolving tech sector. Our core services revolve around the recruitment and placement of highly skilled IT professionals, including software developers, data scientists, network engineers, and cybersecurity experts, addressing staffing gaps and project-specific requirements. We excel in identifying and thoroughly vetting top talent, ensuring that candidates not only possess the right technical skills but also align with our clients' unique cultural requirements.

            Industry

            Recruiting and staffing services

            Company size

            11 - 50 Employees

            Headquarters location

            Chicago, IL, US

            Year founded

            2016

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