Engineer - Process Equipment : 26-03362

Akraya; Thousand Oaks (CA); Presencial; USD 52.000 - 59.000; A tiempo parcial

Descripción de la vacante

Akraya is seeking a qualified engineer to ensure reliable operation of clinical and commercial biopharmaceutical facilities and equipment in a highly regulated setting.

The role focuses on integrating new technologies, driving engineering improvements, and maintaining systems to maximize uptime and compliance.

Formación

• Experience in biopharmaceutical operations within a regulated GMP environment.
• Demonstrated ability to analyze complex equipment and processes data.
• Proven track record in diagnosing issues and driving improvements.

Responsabilidades

• Own and maintain biopharmaceutical process equipment systems.
• Lead and implement engineering improvements and upgrades for equipment and facilities.
• Coordinate maintenance to maximize system performance and uptime.
• Oversee commissioning and qualification of systems, interacting with inspectors.
• Diagnose and resolve issues to reduce production downtime and implement corrective actions.

Conocimientos

Root Cause Analysis

Biopharmaceutical/Process Equipment

Process Improvement

Equipment Qualification

GMP Compliance

Root Cause Analysis/RCA

Statistical Process Control/SPC

Maintenance

Equipment Troubleshooting

Descripción del empleo

Contract Type: W2 Contract Duration: 12+ Months Location: Thousand Oaks, CA (Fully Onsite) Pay Range: $38.00 - $43.00 Per Hour

Primary Skills

• Root Cause Analysis (advanced)
• Biopharmaceutical/Process Equipment (advanced)
• Process Improvement (advanced)
• Equipment Qualification (advanced)
• GMP Compliance (advanced)
• Root Cause Analysis/RCA (intermediate)
• Statistical Process Control/SPC (intermediate)
• Maintenance(intermediate)
• Equipment Troubleshooting(intermediate)

Job Summary: This role focuses on ensuring the reliable operation of clinical and commercial facilities and equipment within a biopharmaceutical manufacturing environment. The engineer will be instrumental in integrating new technologies and driving engineering-based improvements to existing systems.

Key Responsibilities

• Own and maintain biopharmaceutical process equipment systems.
• Lead and implement engineering improvements and upgrades for equipment and facilities.
• Coordinate maintenance to maximize system performance and uptime.
• Oversee commissioning and qualification of systems, interacting with inspectors.
• Diagnose and resolve issues to reduce production downtime and implement corrective actions.

Must-Have Skills

• Ability to analyze problems and propose data-driven engineering solutions.
• Strong technical troubleshooting skills with P&IDs and electrical drawings.
• Effective collaboration with diverse teams and adaptable support.

Domain / Industry Experience: Experience in biopharmaceutical operations and manufacturing within a regulated environment, including familiarity with GMP quality systems, is highly preferred.