(Contract) Senior Process Engineer

Kymanox; United States; On-site; USD 140,000 - 180,000; Full time

Job summary

Kymanox is seeking a Senior Process Engineer to lead the design, development, and optimization of manufacturing processes for pharmaceutical substances and products. The role encompasses regulatory compliance, quality systems, and strong technical leadership across cross-functional teams.

You will develop technical documentation, plan validation studies, technology transfer, and drive continuous improvements while collaborating with Quality, Operations, and Regulatory Affairs.

Qualifications

• Advanced degree in a science-related field (e.g., MS/ME) is required.
• 10+ years of experience in the pharmaceutical or related industry.
• Strong knowledge of cGMP, FDA guidance, and quality systems.
• Excellent technical writing and documentation skills (SOPs, batch records, validation protocols).
• Ability to work cross-functionally with Quality, Operations, and Regulatory Affairs.
• Experience with process development, optimization, and technology transfer.

Responsibilities

• Develop manufacturing processes from concept to commercial implementation per regulatory guidelines.
• Create and maintain process documentation including flow diagrams, risk assessments, SOPs, and validation plans.
• Lead root-cause analyses and continuous improvement initiatives to enhance efficiency and quality.
• Plan, execute, and oversee IQ/OQ/PQ validation studies and technology transfer activities.
• Evaluate equipment, conduct vendor assessments, and manage installation and integration in production.
• Ensure compliance with cGMP, FDA regulations, and audit readiness.

Skills

Process engineering

Regulatory compliance

Technical writing

Cross-functional collaboration

Problem solving

Education

Master of Science in Biomedical/Mechanical/Chemical Engineering

Tools

MS Office

Job description

Job Description:

I s Kymanox the right fit for you?

You want to make a difference and have an impact…

You enjoy having an influence in your day-to-day work…

You are motivated by working alongside a team filled with subject matter experts who will help you learn and grow…

You wake up every day and do what you do… because patients deserve better.

If this sounds like you, you’ve come to the right place.

The Senior Process Engineer will join our CMC & Pharmaceutical Sciences team and lead the design, development, and optimization of manufacturing processes for pharmaceutical products, including both drug substance and drug product processes for multiple modalities of drug products. . This role requires expertise in process engineering principles, regulatory compliance, quality assurance, and technical leadership. The successful candidate will drive process improvements while collaborating with cross-functional teams including Quality, Operations, and Regulatory Affairs. In addition to support from a direct, functional manager, work will also be done under the guidance of a senior Kymanox engineer and/or senior project manager.

Responsibilities:

• Develop technical documentation for drug substance and drug product manufacturing across multiple product modalities (e.g., small molecule, biologics, gene therapies) including SOPs, CMC regulatory filings, manufacturing records, technical reports, process validation and technology transfer documents.
• Design and develop manufacturing processes from concept through commercial implementation, utilizing industry best practices and regulatory guidelines (FDA, ICH, and other applicable standards).
• Lead root cause analysis and implement continuous improvement initiatives to enhance process efficiency, reduce costs, and improve product quality and yield.
• Create and maintain comprehensive process documentation including process flow diagrams, risk assessments, standard operating procedures (SOPs), batch records, and validation protocols.
• Plan, execute, and oversee process validation studies (IQ/OQ/PQ) and technology transfer activities; ensure full regulatory compliance throughout the validation lifecycle.
• Evaluate and select manufacturing equipment, conduct vendor assessments, and oversee equipment installation, qualification, and integration into production workflows.
• Ensure all processes comply with cGMP, FDA regulations, and company quality systems; support regulatory submissions and maintain audit readiness.
• Partner with Quality, Operations, Product Development, Regulatory Affairs, and Supply Chain teams to ensure seamless process execution and continuous improvement.

Educational Background:

• The ideal candidate will have an advanced degree (e.g., Master of Science, Master of Engineering) in a science-related field such as Biomedical Engineering, Mechanical Engineering, or Chemical Engineering.

Experience:

• 10+ years of experience in the pharmaceutical or combination products industry.
• Demonstrated expertise in drug substance and drug product process development, process optimization, and continuous improvement methodologies.
• Strong knowledge of cGMP regulations, FDA guidance documents, and quality systems
• Excellent technical writing and documentation skills. Ability to independently support development of technical documentation such as SOPs, batch records, validation protocols, technical reports, and CMC-related content.
• Strong problem-solving abilities with proven analytical thinking.
• Effective communication and interpersonal skills with ability to work across departments
• Experience with MS Office products (Outlook, Excel, PowerPoint, Word) strongly preferred.

Desired Aptitude and Skill Set:

• Detail-oriented
• Strong organizational skills and verbal/written communication skills
• Highly motivated self-starter with a sense of ownership and willingness to learn
• Thrive in a fast-paced, growing, and dynamic work environment
• Ability to form partnerships with internal stakeholders
• Seasoned soft skills (i.e., high EQ)
• Technology savvy

Travel:

Up to 10% travel is possible for support at tradeshows, conferences, and related events. A passport is required for this job.