Sr. Process Engineer - MSAT, GMP, Tech Transfer

About the role

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?

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.

Physical demands: frequently stand, walk, sit; talk or hear; use hands to finger, handle or feel; occasionally reach with hands and arms; occasionally climb or balance; occasionally taste or smell; frequently lift and/or move up to 25 pounds. No special vision requirement. May occasionally work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals. Reasonable accommodations may be made for individuals with disabilities.

Travel expectations: up to 5% domestic travel.

Responsibilities

• Perform tech transfers of new processes and technologies into the site
• Prepare documentation to support process validation and batch manufacturing
• Troubleshoot manufacturing processes
• Complete process deviations and investigations
• Coordinate lab studies with the formulation development lab
• Provide technical assistance for process tech transfer and validation efforts for assigned manufacturing projects
• Write Master Batch Records with a strong understanding of equipment, critical process parameters, in‑process tests, etc.
• Monitor manufacturing processes during production runs to assess any technical process issues and provide troubleshooting support as needed
• Author manufacturing investigations and complete CAPA assignments
• Compose process validation documentation, including CQA assessment, pFMEA risk assessment, and process validation protocols
• Identify specific parameters, sampling, and tests used in the validation protocols of new and existing products
• Interact with clients during routinely scheduled project meetings
• Ensure 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

Skills

• Excellent verbal communication, written communication, documentation, negotiation, critical thinking, analytical, problem solving, detail orientation, organization and time management skills
• 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)
• Ability to interact with internal stakeholders and external customers

Schedule

100% on‑site position. 1st Shift: Monday – Friday, 8:00 am – 5:00 pm.