Process Engineer
| Company | Sequoia Biotech Consulting |
|---|---|
| Location | Raleigh, NC, USA |
| Salary | $107000 – $130000 |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior |
Requirements
- Bachelor’s degree in Engineering, Bio/Pharma Science, or related technical field of study.
- 5-7 years of experience in drug substance manufacturing or drug product manufacturing, with a preference for large molecule, biologics drug substance.
- Extensive experience with authoring, updating, and reviewing SOPs and technical documentation related to manufacturing operations.
- Experience working with manufacturing batch records and associated documentation.
- Experience in a manufacturing support role such as MSAT, MS&T, Manufacturing Services, etc.
- Understanding of FDA regulations and GMP practices.
- Any exposure to MES (Manufacturing Execution Systems), electronic batch records is a plus but not required.
- Experience working on fast-paced, matrix, cross-functional team projects with defined timelines and deliverables.
- Excellent computer, verbal, and written communication skills.
- Innovative problem-solving skills and an integrated view of business/scientific issues.
- Accountable and responsible individual to perform as intended for clients.
- Willingness to travel to various clients when needed, with acceptable limitations during noted health pandemics or related constraints.
Responsibilities
- Author, update, and review SOPs and technical documentation related to manufacturing operations.
- Work with manufacturing batch records and associated documentation.
- Provide support in a manufacturing support role such as MSAT, MS&T, Manufacturing Services, etc.
- Ensure compliance with FDA regulations and GMP practices.
- Collaborate on fast-paced, matrix, cross-functional team projects with defined timelines and deliverables.
- Assist in the development and implementation of manufacturing processes and procedures.
- Provide technical support for the product/process lifecycle and related activities.
- Support client requirements to lead or help process or engineering projects at vendors or other third-party contract companies, as needed.
- Provide support for improvement projects regarding processes and systems.
- Analyze and recommend improved technology to increase quality and efficiency.
- Provide technical analysis and support for new or improved process systems.
- Facilitate and schedule meetings with subject matter experts across the organization.
- Ensure compliance with cGMP, regulatory, and industry standards.
Preferred Qualifications
- Any exposure to MES (Manufacturing Execution Systems), electronic batch records is a plus but not required.