Corporate/G&A Process Mechanic - Exton, PA Exton, Pennsylvania

Orbis Clinical is seeking a Process Mechanic located in Exton, PA for 12 months.

Job Title: Process Mechanic

Location: Exton, PA

Contract: 12 months

Job Summary

Under general direction, the Maintenance Mechanic is responsible for monitoring, operation, performing preventive maintenance and corrective maintenance of GMP and non-GMP utilities and HVAC equipment as well as process related equipment. System operation includes, but is not limited to, plant steam, clean steam, chilled water, cooling towers, compressed air systems, and pharmaceutical grade water systems (WFI water) equipment under GMP operation. Analyzes results and may develop testing and maintenance specification on new and existing equipment. Prepare reports with recommendations for solutions to technical problems. The ability to function in a fast-paced, highly-technical environment and communicate effectively is essential to success.

This position will require weekend on-call rotation and some off-hour emergency response.

Essential Functions

• Maintain GMP and non-GMP utilities related to the pilot plant and R&D facility.
• Perform preventive and corrective maintenance on process related equipment. Maintains spare parts inventory for critical equipment.
• Schedule preventive maintenance and corrective work orders working with user groups.
• Develop and adhere to all 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 the departmental and inter-functional level.
• Ensure adherence of operations to cGMP as well as 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 and the R&D Facility.

Requirements

• High School Diploma required, Associates Degree or equivalent experience preferred.
• A minimum of 5 years working experience in a cGMP Facilities department in a FDA-regulated industry with Associates Degree, or a minimum of 7 years working experience in a cGMP Facilities department in a FDA-regulated industry with High School Diploma.
• Prior experience in a GMP plant and experience with 21 CFR Part 11.
• Knowledge of cGMP/EMEA and JP regulations.
• Experience with inspections/audits by the FDA or other similar regulatory agencies.
• Experience with CMMS software.
• Working knowledge of Microsoft operating systems and proficiency in MS Office applications.
• Ability to prioritize and successfully manage complex and competing projects.
• Effective problem solving and reasoning skills.
• Demonstrated ability to deliver effective troubleshooting solutions under tight timelines and delivery pressures while maintaining composure and strong performance.
• Effective interpersonal, written and oral communication skills.
• Other Information (, Physical Requirements, On-Call Schedules, etc.)
• Limited handling of laboratory equipment, chemicals, and biological materials
• While performing the duties of this job the employee is frequently required to stand, walk, use hands to fingers, handle or feel objects, tools, or controls; reach with hands or arms; climb or balance; stoop, kneel, crouch, or crawl; and talk and hear. The employee is occasionally required to sit.
• The employee must frequently lift and or move up to 50 pounds.
• This position will require weekend on-call rotation and some off-hour emergency response.

Compensation Details:

• Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
• The Pay Range for this position is $31.61 – $33.79 per hour, can vary depending on employment status.
• Orbis Clinical provides W2 Employees with options for Health Benefits and 401K.

EEO and Reasonable Accommodation Statement:

Epic Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.