Process Maintenance Specialist

Role: Process Maintenance Specialist

Location: Raleigh NC (onsite)

Duration: 6 months

Interview and Offer Same Day if goes well 2 30 Minute Interviews

Description:

Process Maintenance Specialist II

Client is looking for someone to start on site ASAP as a process maintenance mechanic with experience in a GMP pharmaceutical environment working with machinery including isolators autoclaves buffer prep skids and bioreactors. For the first 26 months candidate will work 6 AM to 4 PM schedule taking apart piping cleaning up in passivation for loops and machines and changing gaskets and diaphragm seals for w5 clean steam generators and bioreactors for 2 buildings. Production is expected to start between AugustDecember at which point the role will transition to commissioning and validation someone with this experience will be extended. Once this is complete role will transition to FAT for 2 buildings currently in construction and experience with FAT related to expansion would be preferred.

Must have:

• Experience with isolators
• Process maintenance in GMP environment

Plus:

• Gowning in class C environment (more likely to extend if they have this) would not be until EO 2025
• Utilities

Bad resumes he has seen: manufacturing associates and utility mechanics that operate machinery but havent maintained equipment.

Heres a Similar (NOT EXACT) JD from last year Job is Similar but more in the beginning stages than this one

What Youll Do

• Performs preventative maintenance and repairs on process equipment such as bioreactors centrifuges ultrafiltration skids parts washers autoclaves isolators and fillers
• Provides recommendations to develop preventative maintenance plans to minimize equipment downtime
• Contributes to Standard Operating Procedure (SOPs) development and revisions for process maintenance related activities
• Diagnoses and troubleshoots equipment malfunctions
• Assists in the installation and commissioning of new equipment
• Maintains accurate maintenance records and documentation
• Follows SOPs to ensure compliance with safety and Good Manufacturing Practices (GMP) quality standards
• Adheres to all safety requirements and follows safe work practices
• Notifies management or Environmental Health & Safety (EHS) when unsafe conditions or hazards are found
• Attends all required safety and health training
• Supports site operations and emergency work orders during offhours as needed
• Performs spare parts assessments as required
• Other duties as assigned

Who You Are

You have knowledge in mechanical electrical and control systems. You have knowledge of GMP requirements. You have effective communication skills both written and oral. You have the ability to work in a team environment.

Basic Requirements

• High School Diploma/GED
• 4 years of maintenance experience in a pharmaceutical or similar manufacturing setting
• Experience with Computerized Maintenance Management Systems (CMMS)
• Knowledge of mechanical electrical and control systems
• Knowledge of GMP requirements
• Effective communication both written and oral
• Ability to work in a team environment
• Knowledge of lean manufacturing principles
• Strong problemsolving and time management skills
• Ability to train and mentor others

Preferred Requirements

• Associate degree in Mechanical Electrical or Chemical Engineering or a related field
• 5 years of maintenance experience in a pharmaceutical or similar manufacturing environment
• Certified Maintenance & Reliability Professional Certified Maintenance & Reliability Technician or certification in another relevant field