Process Development Engineer

4 weeks ago

Thousand Oaks, United States ACL Digital Full time

Job Title: Process Development Engineer/Pharma/Biotech

Location: Thousand Oaks, CA

Duration: 12 Months

Description:

Onsite 100% Thousand Oaks.

NO RELOCATION CANDATATES.

Ideal candidate: 2 YOE in drug product manufacturing. Previous experience in pharma or biotech industry with filling equipment, GMP experience. Experience with analytical equipment such as Osmometers, Spectrophotometers, TOC analyzers, etc. Must have equipment trouble shooting & continuous on going plant support experience.

Top 3 Must Have Skill Sets:

*Previous experience in pharma or biotech industry

*Experience with analytical equipment such as Osmometers, Spectrophotometers, TOC analyzers, etc.

*Must have equipment trouble shooting & continuous on going plant support experience

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

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