Associate Specialist, Engineering - 2nd Shift (Onsite)
Core
Support the design, commissioning, and operations of a new sterile clinical manufacturing facility for small molecules, biologics, and vaccines.
Role type
Associate Specialist, Engineering (Manufacturing Operations)
Builds
Sterile clinical manufacturing capacity for drug products
Domain
Pharmaceutical manufacturing / Biotechnology
Required skills
GMP compliance, aseptic handling, equipment qualification, process development, technical writing, data review, troubleshooting, change control, deviation management, regulatory readiness
Preferred skills
pharmaceutical/biotech internship, machine-shop or equipment assembly experience, cross-functional collaboration, root cause analysis
Technologies
SAP, HMIs, calibration databases, Microsoft Office
Responsibilities
Provide technical support for formulation, process development, scale-up, and technology transfer; support commissioning and qualification of sterile manufacturing equipment; execute sterile operations including filling and lyophilization; maintain batch records, SOPs, and technical protocols; contribute to facility and process improvements; perform material movement and inventory checks.
Seniority
Entry-level / Associate