Process Engineer II – Vaccine Manufacturing
New Mexico
Our Client is a global leader in contract research and manufacturing for the pharmaceutical and biotechnology industries. We are seeking a Process Engineer II to support the transfer, scale-up, and documentation of vaccine manufacturing processes. In this role, you will lead process activities, including formulation, filling, and GMP operations, while providing guidance and training to team members.
Key Responsibilities:
- Lead process activities for vaccine formulation and filling operations, including equipment preparation, bulk formulation, sterile filtration, and filling support.
- Act as an SME for GMP investigations (CAPA, departures, CCRs) and manage from initiation to closure.
- Interact directly with clients to communicate progress and technical details.
- Develop and optimize procedures and batch records to meet client and facility requirements.
- Ensure compliance with safety standards and GMP regulations.
- Provide training on SOPs, equipment operation, and client-specific processes.
Qualifications:
- Bachelor’s degree in Biology, Chemical Engineering, or related field.
- Minimum 3 years of process engineering experience, preferably in vaccine or pharmaceutical manufacturing.
- Experience with aseptic fill/finish and vaccine production is highly preferred.
- Strong written and verbal communication skills.
Other Skills:
- Attention to detail and strong problem-solving skills.
- Ability to work independently and mentor team members.
- Familiarity with cleanroom environments and aseptic techniques