Junior HIL Validation Engineer responsible for reviewing test procedures and validating system requirements. Working in a hybrid model for a global engineering and consulting service provider.
About the role
- Facilities Maintenance Engineer managing equipment maintenance and operational procedures at Bachem. Collaborating with validation, quality assurance, and providing technical guidance in a pharma setting.
Responsibilities
- Responsible for maintenance and operational procedures for critical systems
- Provide support in planning and execution of shutdowns of equipment
- Responsible for troubleshooting and providing corrective action directives
- Participate in calibration process and cycle designs; implement the necessary process change through engineering change control procedures
- Collaborate with the validation department regarding change control requalification and validation of change
- Use understanding and knowledge of PLC control directly or through PLC engineering to participate in making necessary changes in process and mechanical control
- Collaborate with Quality Assurance in PR and SOP writing, and participate in review and corrective action related to mechanical or process deviation of equipment
- Routinely makes technical decisions affecting equipment/facilities and processes
- Identifies critical issues, investigates alternatives, makes recommendations, and develops and implements plan(s) for resolution
- Provides assistance and guidance within the work team to resolve technical and non-technical issues
- Follow applicable safety standards and procedures while working under company guidelines and cGMP processes
- Complete paperwork required for equipment and maintenance data into the department’s calibration processes.
Requirements
- Bachelor’s degree in electrical, mechanical or industrial engineering with at least 5 years relevant experience or Associate degree with at least 10 years relevant experience or High School Diploma with at least 15 years’ relevant experience
- 1-3 years’ experience with instrumentation, electrical systems, mechanical processes preferably in a bio/pharmaceutical or other related industry
- Direct related experience with refrigeration, electrical systems, & mechanical processes, preferably in a bio/pharmaceutical or other related industry
- Specific knowledge of vacuum systems, hydraulic systems and electrical circuit and control
- Electronic controls and refrigeration systems knowledge, including low temperature cascading systems and multi-stage compressors
- Understanding / knowledge of PLC control
- Strong analytical math and problem solving skills
- Proficient in reading schematics and diagrams as well as other written materials
- High level of safety awareness
- Excellent written and oral communication skills
- Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
- Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
- Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
- Detail oriented with the ability to troubleshoot and resolve equipment problems
- Ability to work independently and manage one’s time
- Communicate effectively and ability to function well in a team environment
- Previous experience utilizing a Computerized Maintenance Management System
- Lyophilization equipment experience (preferred)
Benefits
- comprehensive Medical/Dental/Vision coverage
- 401(k) plan with employer contribution
- paid vacation
- personal and sick days
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