Alcami
Process Engineer - MSAT, GMP, Tech Transfer
Morrisville, NC, US
Sponsorship not specifiedDetected 1 day ago
NegotiationExcelCustomer SupportGMPFDA RegulatoryCommunicationProblem SolvingCritical ThinkingTime ManagementMicrosoft Office
About the role
- 1st Shift: Monday - Friday, 8:00am - 5:00pm.
- Responsibilities Provides technical assistance for process tech transfer and validation efforts for assigned manufacturing projects.
Responsibilities
- The Process Engineer is accountable for driving results in a fast-paced environment by providing technical support for clinical and commercial parenteral Drug Product manufacturing.
- Monitors manufacturing processes during production runs to assess any technical process issues and provides troubleshooting support as needed.
Requirements
- Bachelor's degree in Engineering, Pharmacy, Chemistry, or related field required.
- Minimum 2 years of experience of technical support and technical transfer in a sterile pharmaceutical manufacturing environment.
- Working knowledge of cGMP requirements related to sterile Drug Product manufacturing processes.
- Proficiency with Microsoft office (Word, Excel, Outlook) required.
- Physical Demands and Work Environment The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel
- The employee is frequently required to sit.
- The employee is occasionally required to stand
- Writes Master Batch Records with a strong understanding of equipment, critical process parameters, in-process tests, etc.
- Qualifications Bachelor's degree in Engineering, Pharmacy, Chemistry, or related field required.
Nice to have
- Working knowledge of EU regulations is preferred.
Skills
- Process Engineer's responsibilities include but are not limited to the following:
- On-Site Expectations 100% on-site position.
Benefits
- Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
Company info
- Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
- Ability to interact with internal stakeholders and external customers.
This listing is sourced directly from Alcami's careers page and normalized into a canonical job model.