POSITION SUMMARY:

We are currently seeking a skilled cGMP Facility Technician with 2-5 years of experience to join the Wheeler Bio team. The ideal candidate will play a crucial role in ensuring the efficient operation and maintenance of our current Good Manufacturing Practice (cGMP) facility. This position requires hands-on experience in facilities in a regulated environment.

RESPONSIBILITIES:

·         Perform routine inspections and maintenance of cGMP facility systems, including HVAC, utilities, and building infrastructure, to ensure compliance with regulatory standards.

·         Execute equipment calibration and validation activities, maintaining accurate records and documentation in accordance with cGMP requirements.

·         Troubleshoot and resolve facility-related issues promptly, collaborating with cross-functional teams to implement corrective and preventive measures.

·         Participate in the planning and execution of facility-related projects, including upgrades, expansions, and renovations, ensuring minimal impact on ongoing operations.

·         Ensure cleanliness and orderliness of cGMP manufacturing areas.

·         Coordinate with external vendors and contractors for equipment servicing, repairs, and installations.

·         Assist in the development and revision of Standard Operating Procedures (SOPs) related to facility management.

·         Respond to emergency situations, following established protocols and contributing to the development of contingency plans.

PROFESSIONAL SCOPE:

• JOB LEVEL: Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
• EXPERIENCE: Typically requires a technical degree and a minimum of 2 years of related experience.
• COMPLEXITY: Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive internal/external working relationships.
• SUPERVISION: Normally receives general instructions on routine work, detailed instructions on new projects or assignments.

LOCATION:

This position is on site at Wheeler Bio’s headquarters in Oklahoma City, OK.

CANDIDATE QUALIFICATIONS:

·         Associate degree or equivalent in a relevant field (Mechanical Engineering, Facilities Management, or related discipline).

·         2-5 years of hands-on experience in cGMP facility management, with a strong understanding of regulatory requirements.

·         Familiarity with HVAC systems, cleanroom environments, and utilities commonly used in pharmaceutical manufacturing facilities.

·         Experience with calibration, validation, and maintenance of equipment in a cGMP setting.

·         Knowledge of safety protocols and procedures, with the ability to identify and mitigate potential risks.

·         Strong problem-solving skills and the ability to work effectively in a team-oriented environment.

·         Excellent communication skills, with the ability to interact with internal teams, external vendors, and regulatory agencies.

·         Detail-oriented, with a commitment to maintaining accurate documentation and records.

Physical Requirements:

Ability to perform facility-based tasks, including standing for long periods and working with various pieces of equipment.

Must be able to lift and carry equipment and materials weighing up to 25 pounds.

Working Conditions:

This position requires flexibility in working hours, including weekends, and on-call duties as necessary.

Work involves the handling of biological materials.