Scalence L.L.C. · 21 hours ago
Process Mechanic
Exton, PA
Full-time
Onsite
Senior Level
$22/hr - $25/hr
5+ years expScalence L.L.C. is seeking a Process Mechanic to monitor and operate GMP and non-GMP utilities and HVAC equipment. The role involves performing preventive and corrective maintenance on various utility and process-related equipment while ensuring compliance with safety and regulatory standards.
Information Technology & Services
Responsibilities
Maintain GMP and non-GMP utilities related to the pilot plant and R&D facility
Perform preventive and corrective maintenance on process-related equipment and maintain spare parts inventory for critical equipment
Schedule preventive maintenance and corrective work orders in collaboration with user groups
Develop and adhere to SOPs and other GMP documentation as required
Monitor activities of outside contractors supporting maintenance and calibration activities
Participate in planning and process improvement activities at departmental and inter-functional levels
Ensure adherence to cGMP, industry safety standards, and OSHA guidelines
Interact cross-functionally with Downstream/Upstream Operations, Support Operations, Quality Assurance, Quality Control, Validation, and other internal and external functions within the R&D facility
Qualification
Required
High School Diploma required; Associate's Degree or equivalent experience preferred
Minimum of 5 years of experience in a cGMP Facilities department in an FDA-regulated industry with an Associate's Degree, or 7 years with a High School Diploma
Prior experience in a GMP plant and familiarity with 21 CFR Part 11
Knowledge of cGMP/EMEA and JP regulations
Experience supporting FDA or other regulatory inspections/audits
Experience with CMMS software
Working knowledge of Client operating systems and proficiency in MS Office applications
Ability to prioritize and manage complex, competing projects
Strong problem-solving and reasoning skills
Demonstrated ability to deliver effective troubleshooting solutions under tight timelines while maintaining composure and performance
Effective interpersonal, written, and verbal communication skills
Preferred
Associate's Degree or equivalent experience preferred
Company
Scalence L.L.C.
In today’s dynamic and competitive market, success hinges on mastering three key areas: Data Intelligence, Business Resilience, and Digital Experience.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase