Manufacturing Associate I

RepliGen Corporation; Waterford; On-site; EUR 17,000 - 24,000; Full time

Job summary

RepliGen Corporation is seeking a Production Operator 1 in Waterford to assemble products per approved procedures and SOPs. You will follow batch documents and operate within a cleanroom environment while maintaining accuracy in documentation.

You will contribute to daily production targets, support continuous improvement initiatives and work as part of a manufacturing cell to ensure quality and efficiency in all processes.

Qualifications

• Leaving Certificate required.
• Ability to follow written and oral instructions and operate equipment.
• Desirable: CAPA, Cleanroom Operations, GMP, EHS, Packaging and Labelling and Quality.

Responsibilities

• Assemble products following SOPs and approved procedures.
• Maintain a safe, clean work area and complete required documentation accurately.
• Support the team to meet daily production targets.

Skills

Following instructions

Communication

Decision making

Education

Leaving Certificate

Job description

Responsible for assembling products in accordance with approved procedures, quality standards and production requirements. The role includes following SOPs and work instructions and completing required documentation accurately. Maintaining a safe and organized work area, and supporting the team in achieving daily production targets.

Scope of Responsibility

Use / storage / processing / control of materials within relevant areas in the manufacturing operations dept. as per relevant approved documentation including SOP’s / Batch Documents /MO’s/Mfg. Drawings etc.

• Use / storage / maintenance / cleaning of all equipment within the relevant areas in the manufacturing operations department as per approved documentation including SOP’s / Batch Documents /MO’s/Mfg. Drawings etc.
• Achievement of operational targets including but not limited to Efficiency / Right First Time(Rework) / Final Pass Yield (Scrap)/ Doc Error.
• Responsible for the Hourly/Daily Performance of the Mfg Cell where assigned.
• Involvement with Manufacturing Cell based Teams / Teamwork initiatives including but not limited to design / development / and implementation of Teamwork based projects e.g. audits, inspections, project implementation.
• Involvement and active participation with Continuous improvement projects to improve Quality and Efficiency of the Manufacturing Process.
• Complete and Thorough knowledge of Areas of expertise in Terms of Moulding Process , In Process Inspection , Assembly and Packaging as agreed by Shift Training Versatility Goals.
• Accurate reporting of department measures / metrics / controls which may be assigned.
• Maintaining and control of specialized equipment and tools in relevant areas as per applicable SOP’s
• Completion of all Manufacturing and Packaging in process testing as per approved Documentation / SOP’s / Batch Documents / Policies.
• Other duties may be assigned on discretionary basis as required by new developments or changes to the role

Impact of role on business objectives

• The Production Operator 1 Role is key in ensuring that:
• All product is manufactured and produced in a compliant manner.
• Line performance is maintained to ensure that production schedule is met to ensure customer requirements are met in terms of delivery.
• Environmental Health & Safety (EHS) Responsibilities
  • Compliance with Safety standards / Polices / procedures when conducting or carrying out normal duties or work practices.
  • Report all near misses, accidents or dangerous occurrences to their Department Manager/Supervisor immediately or as soon as is practicable thereafter.
  • Document all near miss/ accidents in conjunction with team leader/Supervisor
  • Cast the right shadow and lead by example.
• Quality Responsibilities
  • Compliance with quality standards / procedures / policies / SOP’s and all other approved documentation.
• Problem Solving
  • During routine production from time to time deviations may occur in the process.
  • These deviations may impact on product quality or line efficiency.
  • The purpose of the Problem Solving Process is to provide a mechanism and guidelines to: carry out effective investigations into problems or deviations, implement an effective root cause analysis process that will yield the most likely root cause to the problem, implement effective corrective and / or preventive actions that will provide a high probability that the problem will not reoccur.
• Interpersonal & Communication Skills
  • Effective communication skills are essential to this role both within the Shift team online which consists of Team Leaders/Technician/Production Operators and with other supports within the manufacturing value streams.
  • Within the Shift Team, and during a shift change it will be necessary to communicate current line performance, any issues noted during the shift, upcoming changeovers and current status of line and line documentation.
  • Support and interactive communication with the wider shift members during weekly communication meetings
  • Supportive and interactive communication is required during any training activities.
  • There is an expectation that any interaction /communication with fellow employees, contractors or visitors will be conducted in a respectful and courteous manner, being open honest and consistent.
• Minimum Requirements
  • Leaving Certificate
  • The ability to follow written and/or oral instructions and operate equipment.
• Preferred Requirements
  • Good understanding and knowledge of CAPA, Cleanroom Operations, Continuous Improvement, GMP, EHS, Press Operations, Packaging and Labelling and Quality.
  • Operating at pace and agile decision-making.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being
  • Building strong relationships and collaboration, honest and open conversations.
  • Previous Molding experience highly desirable
  • Previous experience desirable but not essential as full training will be given.

Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated hourly rate for this role is €1_4.75/Hr. Compensation decisions are dependent on several factors including, but not limited to an individual’s qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package_.