Manufacturing Facility Engineer
4 weeks ago
Iovance Biotherapeutics Inc is looking for a highly motivated Manufacturing Facility Engineer to join their team. As a key member of the engineering group, this individual will be responsible for providing expertise in manufacturing facility design, construction, and operation.
The successful candidate will have a strong understanding of manufacturing facility design principles and practices, as well as experience with GMP procedures, including change controls, deviation management, and CAPAs. This role requires excellent technical writing and communication skills, as well as the ability to interface with senior leadership to develop long-term strategic planning consistent with operational strategies.
The estimated salary for this position is $105,000 - $125,000 per year, based on industry standards and location.
Key Responsibilities:
- Design, construct, and operate manufacturing facilities to meet GMP requirements.
- Write, review, and edit technical documents, including drafting and approval of equipment specifications, test protocols, SOPs, CAPAs, and change controls.
- Participate in technology transfer, conference calls, and sharing of technical information.
- Ensure that all documentation is compliant with internal requirements, regulatory requirements, including FDA, EMA, and ISO standards.
Requirements:
- Bachelor's or Master's degree in Chemical, Mechanical, Biochemical Engineering, or a related field.
- At least 2 years of experience in manufacturing facility design, construction, or operation.
- Experience with GMP procedures, including change controls, deviation management, and CAPAs.
- Excellent analytical, communication, presentation, and interpersonal skills.
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