Equipment Engineer

ACL Digital; Thousand Oaks (CA); Presencial; USD 110.000 - 170.000; Jornada completa

Descripción de la vacante

ACL Digital is seeking an Engineer to join the Facilities & Engineering group at the Thousand Oaks site to support drug product manufacturing. The role focuses on ownership of biopharmaceutical process equipment, installation of improvements, and collaboration with QA during commissioning and validation activities.

The candidate will lead investigations, perform root cause analyses, and support new product introductions, with a strong emphasis on data-driven methods and regulatory compliance in

Formación

• Master's degree in Engineering with 1 year of experience or equivalent.
• Bachelor's degree with 2 years of engineering experience.
• Associate's degree with 8 years of engineering experience.
• High school diploma / GED with 10 years of engineering experience.

Responsabilidades

• Own system ownership for Biopharmaceutical process equipment.
• Lead improvements or upgrades to equipment or facility systems.
• Coordinate maintenance to ensure peak capacity.
• Ensure commissioning and qualification of systems are completed and interact with inspectors.
• Monitor performance risks and implement risk reduction strategies.
• Lead root cause analysis and implement corrective/preventive actions.
• Support new product/technology introductions with engineering assessments.
• Perform equipment modifications and support engineering runs.
• Provide shift coverage on a 4x10 schedule including at least one weekend day.

Conocimientos

RCA

SPC

Six Sigma

Predictive Maintenance

Data-driven analysis

Educación

Master's degree in Engineering

Bachelor's degree in Engineering

Associate's degree in Engineering

High school diploma / GED

Descripción del empleo

Provide shift coverage on a four-day, 10-hour-per-day schedule, including at least one weekend day.

Shift work, 4X10 hrs. including at least one weekend day.

Description

The Engineer will be joining Facilities & Engineering (F&E) group within Manufacturing and Clinical Supply organization at Client. The group's mission is to enable introduction and integration of new technologies while ensuring existing clinical and commercial facilities and equipment operate reliably. This position will report into Senior Manager of Engineering supporting drug product supply at Client Thousand Oaks site.

Responsibilities

Provide system ownership for Biopharmaceutical process 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 working at peak capacity.

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.

Solving issues to support and 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.

Provide shift coverage on a four-day, 10-hour-per-day schedule, including at least one weekend day.

Operate independently, adapt quickly, and learn effectively in a fast-paced environment.

Basic Qualifications

• Master's degree and 1 years of Engineering experience
• Bachelor's degree and 2 years of Engineering experience
• Associate's degree and 8 years of Engineering experience
• High school diploma / GED and 10 years of Engineering experience

Preferred Qualifications

• Bachelor's degree in Chemical or Mechanical Engineering
• 4+ years' of relevant work experience with 2+ years' experience in Biopharmaceutical operations/manufacturing environment
• Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
• Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as continuous fill lines (washer, tunnel, isolator, cappers and lyophilization), filling, lyophilization, inspection, as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
• Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
• Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects