Job Description
Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!
Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.
Maintenance Technician is responsible for providing equipment troubleshooting and maintenance support for a new product feasibility project/manufacturing support. Support updates to standard operating procedures (SOP's) and preventative maintenance (PM's) plans, as requested. Responsible for written documentation of activities.
Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) plans. Actively supports, participates and embraces an inclusive team culture including significant interaction with Operations, Quality, Automation, Technology, and other groups as required.
Responsible for supporting:
- Process Equipment (e.g. tanks/bioreactors, filtration skids, chromatography columns)
- Support Equipment (e.g. washers, autoclaves, tube welders/sealers, WFI stills, Clean steam generation)
- Automated Systems (e.g. Distributed Control System (DCS), Programmable Logic Controllers (PLC), robotics, Building Automation System (BAS))
- Clean-In-Place (CIP) Systems
- Maintenance Equipment (e.g. tools and calibration equipment)
- Support to Digital Platforms (eg. SAP, ProCal, Brady)
- Initiate and complete routine calibration tasks, work with and troubleshoot complex process systems
- Contributes to the performance and results of the department
- Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units
- Assisting in the identification, development, and implementation of new systems which enhances the operation and engineering processes
- Decisions are guided by policies, procedures and business plan; receives guidance from manager
- Manage multiple priorities and advance several tasks in parallel
Must be flexible to perform all the following functions and other tasks, as needed:
- Ability to work with and troubleshoot complex process systems to include bioreactors, filtration skids, chromatography columns, washers, autoclaves and CIP skids.
- Testing, adjustment, maintenance, repair, calibration and troubleshooting of complex automated process equipment.
- Support updates of standard operating procedures (SOPs), preventative maintenance (PM) plans/calibration procedures, task lists, etc., as required.
- Identify spare parts for preventive maintenance plans.
- Interface with other departments, contractors and disciplines on scheduling repairs and maintenance of clean utility systems
- Assists with execution of automation, validation and additional testing, as required
- Responsible for written documentation of activities
- Completes preventative maintenance and calibration work orders, resolves deviations, and evaluates equipment performance for efficient operation.
- Efficient and safe maintenance and repair of equipment using Hazardous Energy Control Procedures
- Compliance with current good manufacturing procedures(cGMP), safety and environmental requirements/regulations/guidelines
- Effective maintenance, troubleshooting, and problem-solving skills required
- Ability to manage multiple priorities and advance several tasks in parallel
- Demonstrated instrumentation aptitude
- Proficient in the use of general hand and power tools, instruments and testing apparatus commonly used in maintenance and instrumentation.
- Ability to read P&ID's, electrical drawings, blueprints, etc.
- Routine night shift will be 2-2-3, 12-hour night shift schedule, including holidays and alternating weekends. Required to support an on-call schedule for off-nights and weekends. Successful candidate will be required to work an 8-hour weekday schedule until shift is required.
Required Education, and Experience
- High School Diploma/GED or higher and two years of plant maintenance experience with knowledge of technical craft skills (instrumentation, electrical, plumbing, advanced mechanical, HVAC, and/or multi-stage refrigeration systems)
- Required Experience and Familiarity of regulatory requirements in accordance with GMP manufacturing operations
Preferred Experience and Skills:
- Associate Degree in Industrial Systems, Mechanical, Electronics, Electrical or Instrumentation
- Experience working in a clean room or GMP/regulated manufacturing environment
- Operation, maintenance and/or troubleshooting experience with automated process equipment in the biopharmaceutical field
- Experience with GMP compliant calibration and/or maintenance database systems.
- Knowledge of SAP and DeltaV and Procal
Physical Requirements
- Willing and able to lift 50 pounds, climb ladders and stairs, work on platforms and equipment above floor level.
- Walking, bending, crawling and stooping are required. .
- Required to wear personal protective equipment including safety glasses, earplugs, gloves, hard hats, safety harnesses,etc.
- Position requires clean room gowning during performance of job duties
Skills:
- Effective communication both written and oral
- Effective maintenance, troubleshooting, and problem-solving skills
- Working knowledge of regulatory requirements in accordance with GMP manufacturing operations.
- Proficiency in computer systems and applications including but not limited to: Microsoft Office (Word, Excel and Outlook), Programmable Logic Controllers (PLCs), CMMS Calibration/Maintenance Database Systems.
- Must demonstrate adept leadership skills.
- Strong planning, scheduling, and time management skills.
- Available for “On-Call” work rotation (during off-hours) and weekend overtime, as needed.
#MSJR
VETJOBS
Required Skills:
- Allen Bradley PLC
- Biopharmaceutical Industry
- Build Automation
- Building Automation Systems
- Digital Platforms
- Distributed Control System (DCS)
- Equipment Troubleshooting
- Global Manufacturing
- GMP Compliance
- Lockout Tagout
- Regulatory Requirements
Preferred Skills:
- Autoclaves
- Biopharmaceuticals
- Bioreactor Design
- Business Management
- cGMP Regulations
- Cleaning Equipment
- Column Chromatography
- Database Systems
- Electrical Technology
- Equipment Calibrations
- Group Problem Solving
- HVAC Management
- Ladders
- Leadership
- Maintenance Management
- Manufacturing Support
- Microsoft Word
- Preventive Maintenance
- Process Planning
- Programmable Logic Controller (PLC)
- Quality Management
- Safe Operation
- Time Management
- Troubleshooting
- Written Communication
