Senior GXP Facilities Specialist

Responsibilities

• Perform preventative and corrective maintenance activities to support process equipment and systems, in accordance with established procedures and/or approved practices.
• Support efforts in developing remediation for follow-up and emergency work.
• Responsible for performing all work using all prescribed safety procedures.
• Troubleshoot equipment and systems and repair malfunctioning equipment.
• Work with equipment owners/engineers and direct the performance of work by equipment vendors.
• Responsible for periodic inspections of equipment to ensure they are operating properly and safely.
• Aid in the installation of equipment and write safety and maintenance procedures for new equipment.
• Must be able to effectively train equipment technicians.
• Must be able to lead troubleshooting activities to identify root cause and take immediate and appropriate action to implement the repair.
• Must be able to work with maintenance scheduling software to initiate, execute, and reconcile maintenance work orders.
• Respond to alarms and document activities in accordance with cGMP requirements.
• Work with equipment owners and develop remediation activities for alarms.
• Proficient in performing Quality Management System tasks such as deviation, change control, and CAPA deliverables.
• Must be able to assume a leadership role and effectively communicate to Management when deemed necessary.
• Provide "on-call" support on a rotating basis.
• Support regular 24-7 operation of facility and respond to facilities issues as needed.

Qualifications

• 12+ years of experience performing process support equipment and plant utility maintenance, troubleshooting and repair required.
• 10+ years of experience working in a cGMP environment is required.
• Proven ability to effectively lead, influence and course correct as needed.
• Experience in installation of new equipment and systems, as well as, developing their maintenance SOPs.
• Experience interfacing with multiple external vendors.
• Ability to effectively communicate and collaborate with internal and external stakeholders.
• Ability to work effectively in a collaborative team environment.
• Strong knowledge, troubleshooting skills and maintenance competence on GMP utilities and equipment.
• Proficient knowledge of controls and automation.
• Self-driven, independently motivated, data driven and excellent problem-solving ability.
• Proficient in use of CMMS and BMS systems.
• Experience with Blue Mountain and/or Alberio systems a plus.
• Bachelor’s degree in industrial engineering or related technical field preferred.