Maintenance Technician IV

COMPANY SUMMARY:

RESILIENCE is creating the first sustainable ecosystem for advanced biopharmaceutical manufacturing. We’re building a robust, dynamic, and diverse network of manufacturing capability and talent – investing in innovation every step of the way.

We provide high-tech, end-to-end manufacturing and development solutions to ensure the medicines of today and tomorrow are accessible to all in need. This includes complex medicines, such as cell and gene therapies, viral vectors, and vaccines; as well as proteins and the next generation of medicines.

RESILIENCE believes in access to quality and innovation for all. Our adaptive facilities serve partners big and small. We continuously invest in R&D for next generation manufacturing and development, freeing our partners to focus on the discoveries that impact lives.

We offer customized and scalable processes, the highest quality and regulatory capabilities, and world-class facilities. Through manufacturing that’s faster, more flexible, and less risky, we safeguard the quality of critical medicines and protect the resilience of a vital supply chain.

JOB SUMMARY:

Under minimal supervision, this position will perform varied and complex fabrication, installation, operation, maintenance, calibration, and monitoring, of plant, laboratory, and production equipment, and controls relating to the operation of systems and equipment utilized in a cGMP facility.

MAJOR RESPONSIBILITIES:

• Maintain, test, evaluate, and inspect the operation of critical equipment and systems in order to provide a safe and reliable facility infrastructure.
• Maintain a clean, safe work area and perform all work in accordance with SOPs, and GMP and Environmental, Health and Safety guidelines and local codes
• Monitor and respond to system failures, alarms, and abnormal site conditions by taking appropriate preventive and corrective actions.
• Ability to troubleshoot using a variety of diagnostic tools and standard equipment to isolate malfunctions and effect appropriate corrective actions.
• Perform various preventive, corrective maintenance tasks and set-up activities , on a wide variety of GMP and non-GMP production and facilities equipment such as, clean in place, purified water, water for injection, clean steam, waste neutralization, LN and mechanical refrigeration, boilers, compressed air, HVAC, pump, process tank systems, and measuring (indicating and recording) and test equipment, autoclave, depyrogenation oven, parts washing, isolator, chromatography, and filling and capping equipment.
• Use established internal procedures as well as industry standards, manufacturer procedures, etc. for the proper inspection, diagnosis, and troubleshooting of measuring and test equipment.
• Must be able to work long periods under strict and controlled conditions in a sterile filling environment.
• Responsible for daily operational checks which may include maintaining, repairing, lubricating, inspecting, cleaning and testing of equipment.
• Legibly and accurately document work performed, and in detail, on work order reports.
• Complete required documentation to certify the verification and proper functioning of measurement and test equipment.

• Determines impact of required work, communicates, performs, coordinates, and/or supervises major repairs with other facilities staff/contractor and users to minimize service interruptions.
• Inspects third party repairs and/ or rebuilds for adherence to requirements and the quality of work.
• Ability to multi-task and manage multiple and shifting priorities.
• Requires a flexible work schedule, which may include shift work and weekends to support operating schedules, facility requirements, and / or respond to call-in emergency situations.
• Performs any other related job-duties as assigned.

MINIMUM QUALIFICATIONS:

TECHNICAL KNOWLEDGE/EXPERIENCE:

• High School plus some formal technical education and trade Certificate of Qualification or Technologist Diploma at community college level
• 3-5 years related experience in process equipment and building services
• Good organization and communication skills
• Ability to read architectural, mechanical and electrical drawings, and P&IDs
• Good computer skills
• Positive, and flexible frame of mind, to react to demanding situations

PREFERRED QUALIFICATIONS/EXPERIENCE:

Example:

• Industrial Millwright (433A) license and/or equivalent working equipment in maintenance field will be considered
• Industrial electrician (442A) license
• Experience with processing, filling and packaging equipment
• Experience in a cGMP environment

ADDITIONAL REQUIREMENTS:

• Pre-employment medical and medical re-examination; inclusive of eye examination, performed every 2 years or as per RESILIENCE’s SOPs. Included as part of the medical is a respirator fit test (half mask), and pulmonary function test
• This position requires occasional use of a half face respirator
• This position requires vaccination for Hepatitis A and B
• Gown qualified for Sterile operations in Class A/B clean rooms
• Job requires shift work including weekends, and occasional extended shifts

BEHAVIOURAL:

Demonstrated ability to apply the following behavioural competencies on the job:

Example – select the ones applicable to the role

Teamwork: Working effectively and productively with others

Interpersonal Skills: Effectively communicating, building rapport and relating well to all personality types

Goal Orientation: Energetically focusing efforts on meeting a goal, mission or objective

Organization and Planning: Utilizing logical, systematic and orderly procedures to meet objectives

Leadership: Achieving extraordinary operational results through inspiring, encouraging and developing people

Problem Solving: Anticipating, analysing, diagnosing and resolving problems

Decision Making: Utilizing effective processes to make timely decisions

Written Communication: Writing clearly, succinctly and in a manner understood by the target audience.

Flexibility: Agility in adapting to change. Ability to work independently

Conflict resolution - Effectively broker solutions to resolve conflicts between individuals and groups.

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