Senior External Manufacturing Engineer

Senior External Manufacturing Engineer - Menlo Park, CA - Permanent

Proclinical is seeking a dedicated and technically skilled Senior External Manufacturing Engineer. This is a permanent position located in Menlo Park, CA.

Primary Responsibilities:

The successful candidate will be responsible for overseeing clinical and commercial manufacturing operations for pharmaceutical drug products. This role also extends support to drug substance manufacturing, supply chain, and analytical development activities when required.

Skills & Requirements:

• BA/BS degree in a scientific/technical/engineering field.
• Experience in Pharmaceutical Manufacturing or equivalent.
• Basic knowledge of current Good Manufacturing Practice regulations.
• Working knowledge of documents related to GMP and development regarding Manufacturing, Analytical Development and Supply Chain.
• High proficiency in the use of MS Office applications (Word, Excel, PowerPoint).
• Detail-oriented, highly organized, with a customer-service attitude.
• Interest in learning about technical aspects of CMC activities.

The Manufacturing Engineer will:

• Oversee drug product manufacturing activities at Contract Manufacturing Organizations (CMOs), including development projects and routine manufacturing operations.
• Provide on-site support to oversee critical manufacturing activities at CMOs as needed.
• Use technical expertise to troubleshoot manufacturing process issues.
• Collaborate with Analytical and Quality colleagues, providing technical expertise to drive CMO investigations/deviations to successful resolution.
• Assist in preparing reports detailing data analysis from manufacturing studies along with prospective solutions and benefits.
• Review and organize documents associated with drug product development and manufacturing.
• Assist in authoring relevant sections in support of regulatory filings.
• Assist in drafting, formatting, and routing of SOPs for manufacturing.
• Support activities to ensure compliance with EHS requirements.
• Provide administrative support for activities related to packaging, supply chain, analytical development, and stability when needed.
• Support department approval of contracts and purchase orders.

If you are having difficulty in applying or if you have any questions, please contact Dominic Williams at d.williams@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.