Headcount Solutions are seeking to recruit a Biologics Process Equipment Engineer for one of our multinational clients' sites in Sligo.
Responsibilities:
* To work as a team member to support engineering in pharma operations in line with all safety, regulatory and organizational requirements.
* Develop and modify procedures as needed to support the manufacturing operation.
* Participate in process, equipment, and facilities validations efforts and project implementations.
* Process and equipment engineering Subject Matter Expert for vial filling and isolator equipment from design phase to equipment handover.
* Review and approve process flow diagrams (PFDs), specifications, layouts, and P&IDs. Interface with vendors to ensure that equipment/facility designs are aligned and to ensure efficient transfer of information between vendor and site.
* Review vendor design documentation to ensure compliance with process and technical specifications.
* Lead the FAT and SAT activities ensuring the equipment is designed, fabricated, and tested to meet the technical requirements of the project.
* Support follower equipment installation integration and coordinate vendor supervision as required.
* Support the development of the project commissioning and validation plan.
Requirements:
* A relevant third-level qualification in an engineering, science, or technical discipline (Degree Level or Masters Preferable).
* At least five (5) years of total combined experience in Process / Equipment or Manufacturing Engineering of a Pharmaceutical and Health Care Organization.
* At least three (3) years of experience in the manufacturing environment of a biotechnology, pharmaceutical, or health care plant.
* Previous experience in manufacturing processes of biotechnological drugs, parenteral drugs, solutions preparation, and sterilization operations preferable.
* Experience in new product introductions (drug product) to pharmaceutical facilities is desirable.
Ownership/Accountability:
* This role is accountable for supporting a positive developmental culture within the organization while ensuring compliance with Quality policies.
* Requires good knowledge of Company Policies and Procedures and involves working towards general results to achieve organizational needs.
* The position has a high level of autonomy, and individuals are expected to work on their own initiative.
* Demonstrates an ethos of Right First Time at all times.
* Adheres to and follows all procedures, policies, and guidelines ensuring compliance with cGMP and ISO/FDA regulations and company policies, procedures, and guidelines.
* Shows a high level of tenacity to ensure closure of issues.
EHS Responsibilities:
* Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities.
* Continually be conscious of your own safety and that of others, always complying with safety notices and barriers.
* Report any EHS incidents and/or Near Misses (unsafe acts and conditions) immediately to your supervisor and always raise the event in the EHS system.
* Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement in the EHS system.
* Attend all required EHS training and medical surveillance programs.
* Wear PPE as required.
For further information, please forward your CV.
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