Process Development Engineer

7 days ago

Thousand Oaks CA United States ACL Digital Full time

Job Title: Process Engineer

Location: Thousand Oaks, CA

Duration: 12 Months

Top 3 Must Have Skill Sets:

GMP Experience

Troubleshooting

Engineering

Description:

Onsite 100% Thousand Oaks.

EW will need to report onsite to USTO Monday-Friday, standard business hours 8 AM - 5 PM PT. No remote work

Ideal candidate: 2 YOE in drug product manufacturing. Previous experience in pharma or biotech industry with filling equipment, GMP experience. Experience with filling equipment, washers, autoclaves desired. Must have equipment trouble shooting & continuous on going plant support experience. Top must have skills: GMP Experience, Troubleshooting, Engineering

· Minimum education and experience requirements the hiring manager is looking for in an ideal candidate:

Bachelor's Degree and 2 years of experience. PHD would be overqualified for this role.

The Engineer will be joining Facilities & Engineering (F&E) group within Manufacturing and Clinical supply organization at Amgen. The group’s mission is to enable introduction and integration of new technologies while ensuring existing clinical and commercial facilities and equipment operate reliably.

Responsibilities include:

• Provide system ownership for Biopharmaceutical process and analytical equipment. Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.

• Directing and coordinating equipment maintenance as necessary to ensure systems are in proper working order.

• Ensure necessary commissioning and qualification of systems is completed and interact with inspectors as necessary.

• Monitor systems to identify performance risks and implement risk reduction strategies.

• Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.

• Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.

• Ensure systems are installed and operating safety and comply with pertinent environmental health/safety practice, rules and regulations

Basic Qualifications

Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Day to Day Responsibilities:

• Provide system ownership for Biopharmaceutical process and analytical equipment. Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.

• Directing and coordinating equipment maintenance as necessary to ensure systems are in proper working order.

• Ensure necessary commissioning and qualification of systems is completed and interact with inspectors as necessary.

• Monitor systems to identify performance risks and implement risk reduction strategies.

• Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.

• Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.

• Ensure systems are installed and operating safety and comply with pertinent environmental health/safety practice, rules and regulations

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