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SUMMARY: Shannon - Onsite
The Production Technician is responsible for the assembly, testing, validation support, and documentation of biopharmaceutical processing equipment associated with Multi-Use Technology (MUT) and Single-Use Technology (SUT) systems. Working within a regulated manufacturing environment, the role ensures products are manufactured, tested, and documented to the highest quality and compliance standards.
PRIMARY DUTIES AND RESPONSIBILITIES:
Manufacturing & Assembly
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Assemble biopharma production pump, Multi Use Technology (MUT) systems, and Single-Use Technology (SUT) assemblies in accordance with engineering drawings, work instructions, and quality standards.
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Perform mechanical assembly, fitting, tubing installation, component integration, and final product configuration.
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Conduct visual inspections throughout the assembly process to ensure compliance with customer and regulatory requirements.
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Follow standard operating procedures (SOPs), manufacturing instructions, and Good Documentation Practices (GDP).
Testing & Validation Support
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Perform functional, mechanical, and operational testing on completed assemblies and systems.
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Carry out Production Testing, Installation Qualification, Operational Qualification, and Performance Qualification activities as required.
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Utilize measuring and testing equipment to verify product specifications and performance.
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Assist with troubleshooting and root-cause investigations of assembly or testing failures.
Electrical & Control Systems
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Read and interpret electrical schematics, wiring diagrams, panel layouts, and control system documentation.
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Upload approved software and configuration files to PLC and HMI systems as required during manufacturing and testing activities.
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Support commissioning activities through verification of electrical and control system functionality.
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Perform basic fault finding and troubleshooting of electrical components including power supplies, sensors, instrumentation, actuators, PLCs, HMIs, and communication networks.
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Identify, diagnose, and report electrical or control system issues, supporting corrective actions and resolution activities.
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Utilize electrical test equipment as required to verify wiring integrity, component functionality, and system operation.
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Ensure all electrical work is performed in accordance with company procedures, engineering requirements, and applicable safety standards.
Quality & Compliance
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Ensure all manufacturing activities are completed in accordance with good manufacturing practices, ISO, and company quality requirements.
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Complete production records, test reports, validation documentation, and traceability records accurately and on time.
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Maintain component and material traceability throughout manufacturing processes.
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Participate in quality investigations, non-conformance reporting, and corrective and preventive action (CAPA) activities as required.
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Promote a strong quality culture and Right First-Time approach.
Documentation & Systems
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Record manufacturing and testing results within ERP, MES, or other electronic systems.
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Maintain accurate production documentation and revision-controlled records.
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Support the review and continuous improvement of manufacturing procedures and work instructions.
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Ensure compliance with data integrity and documentation standards.
Continuous Improvement
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Identify opportunities to improve manufacturing efficiency, quality, safety, and productivity.
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Participate in Lean, 5S, and continuous improvement initiatives.
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Contribute to process optimization and manufacturing best practices.
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Support new product introductions (NPI) and process validations as required.
Cross-Functional Support
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Collaborate effectively with Engineering, Quality Assurance, Quality Control, Supply Chain, and Operations teams.
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Support inventory management, material handling, packing, shipping, and other production activities as required.
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Assist in training new team members and sharing technical knowledge and best practices.
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Support customer, supplier, and auditor visits when required.
Health, Safety & Environment
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Adhere to all company Health, Safety, Environmental, and Quality policies.
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Maintain a clean, organized, and safe work environment.
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Properly use personal protective equipment (PPE) and follow safe working practices.
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Participate in safety initiatives and risk assessments.
Education & Experience
Essential
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Technical qualification in Mechanical Engineering, Manufacturing, Mechatronics, Biotechnology Equipment, or a related discipline.
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Previous experience in a manufacturing, assembly, or production environment.
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Experience working with mechanical assemblies, tools, measuring equipment, and technical drawings.
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Computer literacy and experience using production or ERP systems.
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Strong documentation and record-keeping skills.
Desirable
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Experience in biopharmaceutical, medical device, life sciences, or regulated manufacturing environments.
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Knowledge of Single-Use Technology (SUT) systems and bioprocess equipment.
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Understanding of GMP, FDA, ISO 9001, ISO 13485, or similar quality standards.
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Experience supporting validation or testing activities.
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Lean Manufacturing or Continuous Improvement experience.
Key Competencies
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Strong mechanical aptitude and problem-solving skills.
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Excellent attention to detail.
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Ability to work independently and within a team environment.
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Effective communication and interpersonal skills.
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Strong organizational and time-management abilities.
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Adaptable and flexible approach to changing business needs.
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Commitment to quality, compliance, and safety.
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Results-oriented with a continuous improvement mindset.
Compensation Information
The expected pay range for this position is 45,000 - 55,000 annually.
Ultimately, in determining your pay, we may also consider your experience, and other objective job-related factors. This position may be eligible for a bonus or other incentive plan, as well as other forms of compensation.
Are you ready to join a different kind of company where our people, our culture, and our commitments are centered around providing trusted solutions that improve lives around the world?