(Contract) Process Engineer

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

• 5+ 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.