Engineer II
5 days ago
The Engineer II (MTS) supports late-stage and commercial drug product manufacturing within the Manufacturing Technical Services team. This role plays a key part in technology transfer, process validation, and continuous improvement to ensure robust drug product manufacturing. The successful candidate will contribute to the Drug Product (DP) Technology Transfer team, supporting activities that enable the reliable production of commercial products.
Key Responsibilities:
- Assist in process scale-up, optimization, and technology transfer of new drug product manufacturing at contract manufacturing organizations (CMOs).
- Participate in due diligence and technical assessments to ensure readiness for technology transfer.
- Assist with deviation assessments, change control documentation, and CAPA development.
- Participate in risk assessments and provide technical input to support ongoing GMP operations.
- Collect and analyze process data to identify trends and areas for improvement.
- Prepare data summaries, reports, and visualizations for internal and management review.
- Support the development and execution of process validation protocols and sampling plans.
- Assist with documentation of validation and launch activities to ensure GMP compliance.
- Identify and contribute to process improvement initiatives.
- Collaborate with cross‑functional teams to evaluate and implement operational enhancements.
- Conduct lab‑scale experiments to support development and manufacturing investigations.
- Ensure commercial drug product manufacturing readiness prior to each lot.
- Support timely closure of deviations, investigations, and CAPAs.
- Contribute to authoring and maintaining process control documentation.
- Communicate key updates to cross‑functional teams.
- Support achievement of Manufacturing Technical Services and department goals.
- Understanding of cGMP principles and regulatory expectations.
- Strong organization, communication, and teamwork skills.
- Ability to work independently and adapt to changing priorities.
- Technology transfer experience and prior collaboration with CMOs are a plus.
Work Environment & Physical Requirements:
- Must comply with all laboratory safety requirements.
- May be required to lift up to 50 lbs.
- Ability to travel between local manufacturing and development sites.
Education:
- B.S. in a relevant scientific or engineering field.
Experience:
- 2+ years in a laboratory or GMP manufacturing environment.
Technical Skills:
- Proficiency with MS Word, Excel, and PowerPoint.
- Data trending and analysis experience (Excel, JMP preferred).
Contract Duration:
- 1 year contract
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