Utilities Engineer

Responsibilities

Maintaining utilities and media systems at state-of-the-art levels in accordance with the production requirements and ensuring continuous availability without unplanned downtime. Performing comprehensive inspection, maintenance, servicing, and troubleshooting on utility and technical building system in accordance with pharmaceutical and technical requirements. Overseeing all contractor activities for maintenance, repairs, and troubleshooting while coordinating all necessary documentation, testing, and release approvals with manufacturing, validation, and quality management.

Tasks

• Carries out engineering activities and leads internal projects including investments, planned exceptions, and change controls for repairs, updates
• Carries out requirement planning and order placement in SAP
• Conducts staff training
• Develops recommendations, solutions and corrective actions for the elimination of weak points in the continuous improvement process
• Contributes to process and equipment optimization initiatives that improve long-term system availability of all utilities and media systems
• Ensures documentation according to cGMP
• Ensures the technical availability of equipment, machines, devices, systems, and utilities including availability of replacement parts.
• Establishes user requirement specifications for new equipment and service and maintenance specifications (including all relevant SAP procedures).
• Provides technical supervision, coordination, and oversight of external contractors and service providers
• Inspects the equipment related documentation (e.g. user requirement specification, operating instructions)
• Issues and revises SOPs and QC forms
• Monitors existing utilities, machines, devices, systems, and equipment technical performance
• Organizes and supervises equipment installation, startup, and approval/release
• Performs daily inspections and continuous troubleshooting and weakness analysis
• Supports external and internal audits, providing tours, presenting documentation and trending, and defending procedures.
• Coordinates and supports qualification activities for all primary equipment/utilities
• Participates in rotating On-Call-Duty to respond to equipment or system failures
• Takes on special tasks at the instruction of the site president and site directors (e.g. mediafill support)
• While performing the duties of this job, is regularly required to stand, sit, walk, climb stairs/ladders, kneel, crouch, or wear safety gear.  Must regularly lift and / or move up to 10 pounds, frequently lift and/or move up to 25 pounds, and occasionally lift and/or move up to 50 pounds.
• Other duties as assigned.

Minimum requirements

• Bachelor’s degree in a science-related or technical field or equivalent work experience
• Technical or mechanical vocational training
• 5+ years work experience in pharmaceutical or food industry
• Experience with Vetter systems and maintenance or similar strongly preferred
• Communication in English
• Knowledge of MS Office

Overview

Join our team at Vetter Development Services, an international leader in aseptically prefilled syringe systems, cartridges, and vials production. As a family-owned Contract Development and Manufacturing Organization (CDMO), we are dedicated to supporting our clients through all stages of product development and manufacturing.