(Contract) Senior Process Engineer
On-siteSanford, North Carolina, United States
Job Summary
Develop technical documentation for drug substance and drug product manufacturing across multiple modalities, including SOPs, CMC filings, and validation protocols. Design and develop manufacturing processes from concept through commercial implementation while leading root cause analysis and continuous improvement initiatives. Plan, execute, and oversee process validation studies and technology transfer activities to ensure full regulatory compliance. Evaluate manufacturing equipment, conduct vendor assessments, and oversee installation and qualification into production workflows. Partner with cross-functional teams including Quality, Operations, and Regulatory Affairs to drive process efficiency and maintain audit readiness. This 100% onsite role in Sanford requires 10+ years of pharmaceutical process engineering experience and supports a team focused on patient outcomes. Up to 10% travel is possible for trade shows and conferences.
Required Qualifications
- 100% onsite in Sanford
- Advanced degree (e.g., Master of Science, Master of Engineering) in a science-related field such as Biomedical Engineering, Mechanical Engineering, or Chemical Engineering
- 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
- Passport
Desired Qualifications
- Experience with MS Office products (Outlook, Excel, PowerPoint, Word)
- 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
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.