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Specialist, Engineering
4 weeks ago
Job Description
The Mechanical Services Engineer (Process) will troubleshoot and maintain process and process support equipment used in a drug substance manufacturing operation. Develops Standard Operating Procedures (SOP's) and Preventative Maintenance (PM's) plans, as needed. Responsible for documenting activities. Handles SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) plans. Actively supports an inclusive team culture with interaction across various departments.
Responsible for supporting:
- Process Equipment (e.g. tanks/bioreactors, filtration skids, chromatography columns)
- Support Equipment (e.g. washers, autoclaves, tube welders/sealers)
- Automated Systems (e.g. Distributed Control System (DCS), Programmable Logic Controllers (PLC), robotics)
- Clean-In-Place (CIP) Systems
- Maintenance Equipment (e.g. tools and calibration equipment)
Required to perform the following functions and other tasks, as needed:
- Authors SOPs, PM job plans, and change control requests related to equipment modifications.
- Manages small projects for equipment/maintenance-related improvements, including obtaining quotes, drawing/specification review/approval, and review of contracts.
- Interfaces with vendors for equipment testing, parts, and troubleshooting.
- Ensures spare part inventories are established and maintained.
- Supports safety initiatives, including audits and Hazardous Energy Control Procedure updates.
- Conducts troubleshooting and maintenance of equipment to support production.
- Provides training to others.
- Completes written documentation of work performed.
- Executes SAP transactions including spare parts management and change control.
- Monitors equipment operations performance by analyzing work orders.
- Collaborates with reliability engineers for periodic assessments.
- Supports atypical investigations as needed.
- Ability to lift/move materials/equipment weighing up to 100 pounds.
- Effective communication
- Works as part of a team to achieve operational goals with compliance.
Education:
- Bachelor's degree in science, engineering or related field with a minimum of 2 years of relevant equipment experience
Required Experience and Skills
- Experience in a manufacturing setting with mechanical troubleshooting and repair of automated equipment
- SAP experience (or equivalent) related to plant maintenance and spare parts procurement systems.
- Regulatory knowledge in alignment with GMPs
- Ability to work in a team environment.
- Strong communication skills.
- Ability to handle multiple priorities.
- Ability to work with computer control equipment including Programmable Logic Controllers and/or Distributed Control Systems
- Proficiency in computer systems and applications including Microsoft Office.
Preferred Experience and Skills
- Maintenance/calibration experience, project engineering, or operations experience
- Experience in job plans authoring and spare parts management.
- Project management experience including change control and equipment qualification.
- Experience with biopharmaceutical manufacturing equipment.
- Six Sigma green and/or black belt certification
Residents of Colorado
U.S. Hybrid Work Model
Search Firm Representatives Please Read Carefully
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
1st - DayValid Driving License:
NoHazardous Material(s):
CIP and cleaning suppliesJob Posting End Date:
05/25/2024Requisition ID:R293155
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