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Drug Product Process Engineer Jobs (NOW HIRING)

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.

Sr. Process Engineer

Charleston, SC · On-site

$97K - $125K/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.

The 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 Process ...

Job Summary The 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 ...

$76K - $99K/yr

In the later stages of development, engineers optimize the drug substance and drug product processes and lead manufacturing campaigns. Engineers also work cross-functionally to transfer the optimized ...

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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 9, 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:

Sr. Process Engineer

Charleston, SC • On-site

Alcami Corporation
Pharmaceutical and Medicine Manufacturing • 501 - 1,000 employees

$99K - $128K/yr

Full-time

Re-posted 2 days ago


Alcami rating

7.8

Company rating: 7.8 out of 10

Based on 9 frontline employees who took The Breakroom Quiz


Job description

 

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

Are you interested in joining our team?

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. The Sr. Process Engineer's responsibilities include but are not limited to the following: performing tech transfers of new processes and technologies into the site, preparation of documentation to support process validation and batch manufacturing, troubleshooting manufacturing processes, completing process deviations and investigations, and coordinating lab studies with the formulation development lab. These functions will be executed following standard operating procedures and batch records in accordance with FDA and EU requirements and current Good Manufacturing Practices.

On-Site Expectations
  • 100% on-site position.
  • 1st Shift: Monday - Friday, 8:00am - 5:00pm.
Responsibilities
  • Provides technical assistance for process tech transfer and validation efforts for assigned manufacturing projects.
  • Writes Master Batch Records with a strong understanding of equipment, critical process parameters, in-process tests, etc.
  • Monitors manufacturing processes during production runs to assess any technical process issues and provides troubleshooting support as needed.
  • Author manufacturing investigations and complete CAPA assignments.
  • Composes process validation documentation, including CQA assessment, pFMEA risk assessment, and process validation protocols.
  • Identifies specific parameters, sampling, and tests used in the validation protocols of new and existing products.
  • Interact with clients during routinely scheduled project meetings.
  • Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
  • Other duties as assigned.
Qualifications
  • Bachelor's degree in Engineering, Pharmacy, or Chemistry.
  • 5 years of experience of technical support in a sterile pharmaceutical manufacturing environment.
  • Previous experience supporting tech transfer of parenteral Drug Products preferred.
Knowledge, Skills, and Abilities
  • Excellent verbal communication, written communication, documentation, negotiation, critical thinking, analytical, problem solving, detail orientation, organization and time management skills required.
  • Working knowledge of cGMP requirements related to sterile Drug Product manufacturing processes.
  • Working knowledge of EU regulations preferred.
  • Proficiency with Microsoft office (Word, Excel, Outlook) required.
  • Ability to interact with internal stakeholders and external customers.
Travel Expectations
  • Up to 5% domestic travel.
Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is required to frequently stand, walk, sit; talk or hear; use hands to finger, handle or feel. The employee is required some of the time to reach with hands and arms. The employee is required occasionally to climb or balance; and taste or smell. The employee must frequently lift and/or move up to 25 pounds. There is no special vision requirement for this job. The employee may occasionally work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals.

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Employment Type: FULL_TIME

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