What are the responsibilities and job description for the Facilities and Maintenance Engineer - GMP Operations and Project position at PHARMALOGIC HOLDINGS?
Job Description
Job Description
Position Title : Facilities and Maintenance Engineer – GMP Operations and Project Support
Company : PharmaLogic
PharmaLogic is a leading contract development and manufacturing organization (CDMO) focused on advancing diagnostic imaging and therapeutic radiopharmaceuticals for cancer treatment. With a robust portfolio in drug development and commercialization, we are committed to delivering cutting-edge therapies to improve patient outcomes worldwide.
Role Description :
We are seeking a hands-on Facilities and Maintenance Engineer with a strong understanding of GMP compliance, equipment qualification processes, and experience contributing to cross-functional projects. In this role, you will play a key part in commissioning and operationalizing our advanced manufacturing facility in Idaho Falls, ID. After the facility's launch, you will focus on supporting maintenance operations, ensuring equipment reliability, and driving compliance with regulatory standards.
This role is ideal for a technically skilled professional with a solid grasp of GMP requirements, IOPQ documentation, and the ability to lead specific project workstreams while collaborating with teams across operations, quality, and engineering.
Key Responsibilities :
Facility Operations : Support the efficient operation of facility systems, utilities, and production equipment in compliance with GMP, FDA, and environmental regulations.
IOPQ Documentation : Collaboratively write, review, and execute Installation, Operational, and Performance Qualification (IOPQ) protocols for new and existing equipment.
Project Leadership : Contribute as a key team member on cross-functional projects, including scope development, timeline planning, and commissioning / testing activities.
Preventive Maintenance : Implement and support preventive and predictive maintenance programs, ensuring equipment reliability and reducing downtime.
Troubleshooting and Repairs : Diagnose and resolve facility and equipment issues, collaborating with maintenance and quality teams to ensure timely corrective actions.
Compliance and Documentation : Maintain technical documentation, including SOPs, user manuals, and maintenance logs, ensuring alignment with regulatory requirements.
Collaboration : Work closely with operations and quality teams to optimize capacity, improve processes, and ensure compliance with safety standards.
Safety and Inspections : Promote a positive safety culture, participate in inspections, and support compliance with environmental health and safety (EH&S) requirements.
Qualifications :
Education : Bachelor’s degree or equivalent in Engineering, Facility Management, or a related field.
Experience : At least 5-10 years of experience in a regulated industry such as pharmaceuticals, biotechnology, or chemical manufacturing, with hands-on experience in GMP environments.
Technical Skills : Proficiency in equipment qualification, IOPQ documentation, and maintenance management in manufacturing or laboratory settings.
Project Experience : Demonstrated ability to lead project workstreams or contribute as a team lead on small- to medium-scale initiatives.
Regulatory Knowledge : Familiarity with GMP, FDA regulations, and cleanroom operations.
Problem-Solving : Strong analytical skills and a proactive approach to addressing challenges.
Communication : Clear verbal and written communication skills to interact effectively with cross-functional teams.
Preferred Experience :
Supporting commissioning and qualification activities for pharmaceutical manufacturing facilities.
Familiarity with cleanroom environments and regulatory standards.
Physical Requirements :
Ability to lift up to 50 lbs. and perform physical tasks such as crawling, stooping, and kneeling.
Strong mechanical aptitude and dexterity for handling equipment and tools.
Benefits :
Competitive salary and bonus potential.
Comprehensive benefits package including medical, dental, vision, disability, and life insurance.
401(k) retirement plan with employer match.
Flexible spending accounts (FSA) and health savings accounts (HSA).
Paid time off program.
PharmaLogic is an equal opportunity employer committed to fostering diversity in the workplace. Employment decisions are made based on qualifications, merit, and business needs.
