Process Engineer II

Work Schedule

12 hr shift/nights

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Position Summary:

Join a team that is unwavering in its commitment to delivering outstanding technical support and expertise to sterile pharmaceutical production 24/7! As a Process Engineer II, you will be pivotal in guaranteeing seamless operations by assisting with customer technical transfers, modifying current processes, and supporting auxiliary systems. Your efforts will be instrumental in driving process improvements to enhance safety, reduce costs, improve quality, and increase Overall Equipment Efficiency (OEE). Work closely with Engineering, Operations, Maintenance, Validation, and Quality teams to ensure compliance with regulations and cultivate a workplace that is free from injuries. This is a 12-hour rotating shift position following a 2-2-3 schedule, either straight days or nights.

Key Responsibilities:

• Provide technical expertise and support to meet business unit objectives and improve OEE, maintaining system construction and documentation.

• Diagnose and resolve complex process and equipment interactions to ensure system readiness, often collaborating with other teams and communicating resolutions to leadership.

• Act as the Subject Matter Expert (SME) regarding equipment and process functionality for Production and Utilities.

• Develop process flow diagrams, problem-solving guides, and advanced troubleshooting aids to increase efficiencies and repeatability, and train internal resources.

• Offer SME input during the development of CAPEX Equipment Upgrades for compliance and efficiency on Sterile Fill/Finish equipment.

• Coordinate planned interruptions for processing areas/building during shutdowns as required.

• Develop, modify, and approve process equipment recipes while adhering to SOPs.

• Offer data assistance for production and quality inquiries, suggesting resolutions and enhancement possibilities.

• Collaborate with Engineering, Operations, Maintenance, Quality, and Safety teams on the production floor, dedicating 70-90% of your time during shifts.

• Collaborate with collaborators to prioritize activities and resolve conflicts.

• Document conditions, actions, and results of work performed in logbooks and shift reports.

• Drive Continuous Improvements using metrics, TPM, 5S, and the PPI process.

Frequent Contacts:

Internal

• Customer Facing Process Engineer, Maintenance, and Operations Colleagues.

External

• Equipment and Supply Vendors

Minimum Requirements/Qualifications:

• Associate's degree in Mechanical, Electrical, or Industrial Engineering

• Three years of experience in processes.

• Ideally 1+ years of Process Improvement experience applying Six Sigma, Lean, 5S, and Trend Analysis approaches.

• Experience in regulated manufacturing environments within Biotechnology, Pharmaceutical, or Medical Device industries is a plus.

• Knowledge of Data Integrity principles for automation systems and audit trail data is advantageous.

• Outstanding attention to detail and organizational skills to manage time and prioritize tasks.

• Strong verbal and written communication skills, along with the ability to establish and maintain effective working relationships.

Other Job Requirements:

• Adhere to OHS policies and procedures to ensure a safe and healthy workplace environment.

• Perform other duties as assigned.