Senior Process Engineer

New York, US
Posted 1 weeks ago by FPC Rehoboth

Job Description

Senior Process Engineer


The Senior Process Engineer will be responsible for the development and scale up of internal manufacturing processes to support the growth and advancement of our regenerative medicine products as well as supporting development and engineering activities associated with outsourced manufacturing.

Responsibilities:

· Work with Development to ensure appropriate equipment and processes are used for internal manufacturing.

· Identify, implement and develop equipment to support scale up of internal manufacturing of intermediates.

· Manage, directly or via peer leadership, junior process engineering staff.

· Identify / develop appropriate primary and shipping packaging for biological tissues and products. Manage external packaging vendors, as appropriate.

· Provide support for manufacturing facility development, buildout, commissioning and qualification.

· Support development of systems for equipment calibration, certification and qualification and ensure compliance with systems.

· Support development of relevant manufacturing metrics, data collection, reporting and process improvements.

· Support the development of regulatory CMC documentation.

Requirements:

· A minimum of 10 years in biopharmaceutical manufacturing engineering / development.

· Degree in biomedical engineering, chemical engineering, or similar related field required.

· Proven experience in improving and scaling up / out manufacturing processes and systems to support biopharmaceutical development.

· Experience with the development of Biologics, cell-based therapies, and/or Advanced Technology Medicinal Products preferred.

All interested and qualified candidates should call Kevin North at 302-226-8070 or email resume to knorth@fpcrehoboth.com

Recruiters Details

Location:
New York, US
Job number:
J56514-REHO-00750
Recruiter:
Kevin North
Office:
Rehoboth
Posted At:
1 weeks ago
Relocation:
No
Job Function:
Process Engineering
Industry:
Biopharmaceutical /Biotechnology
Education:
BS