Plant Equipment Engineer

Recruiter
Randstad
Employment Type
Permanent
Salary
Not disclosed
Randstad logo

Why work for this company?

Our client discovers, develops, manufactures and commercialises medicines, vaccines and diagnostic products, which are complemented by bio-devices, genetic tests and a range of services.

Company Profile:

  • 65+ years of experience in health
  • Nearly $6 billion annual revenues
  • 25 manufacturing sites around the world
  • 10,000 employees worldwide of which 1,100 employees are committed to R&D

This role reports to the Electrical Lead and will assist with Engineering activities associated with the site’s core process plant equipment.

Primary accountabilities are

  • Support the development of a Central Engineering Database and Centre of Excellence for API process plant
  • Engineering oversight of process plant equipment
  • Subject Matter Expert for Engineering Department for existing and new process plant
  • Support the development and delivery of process plant training modules for Engineering Technicians
  • Support the scoping and early Engineering design of new process introductions and process improvement projects
  • Approve design deliverable and hand over documentation associated with process projects
  • Update and maintain relevant site Engineering standards & procedures
  • Scope, develop and lead new projects related to process plant equipment improvements
  • Ensure compliance with all relevant and regulatory policies
  • Ensure that process plant equipment is maintained in accordance with vendor & legislative requirements
  • Support the Safety Controls & Interlock strategy for the site
  • Support the Asset Integrity strategy for the site with particular emphasis on process plant
  • Support the development of the site strategy for process plant equipment risk assessments and compliance with Machinery Directive guidelines

The role will report to the site Electrical Lead and will have a strong relationship with the site Maintenance, Projects, Utilities, Operations, Quality and EHS functions.

Responsibilities

Compliance

  • Ensure regulatory agency policies and standards for plant equipment are fully complied with including Quality, EHS, FDA, HPRA, EPA, HSA
  • Interface with regulatory agencies during site audits and walkdowns
  • Work closely with EHS, Operations, Utilities, Automation and Maintenance personnel to ensure equipment is safe to operate & maintain
  • Utilise the site Change Control process for all site projects ensuring that all changes are captured and assessed/tested/closed out in a timely manner
  • Ensure safety files for process plant equipment are maintained and updated as required
  • Act as Client representative for interactions with project delivery teams and OEM’s in relation to design, Machinery Directive and risk assessments for process plant equipment
  • Attend Factory Acceptance Tests at OEM manufacturing facilities
  • Ensure Pre-Startup Safety Reviews are completed prior to operation and use of existing, modified or new equipment.

Availability of Systems

  • Work closely with Maintenance, Utilities & Operations to ensure process plant equipment reviews and upgrades are implemented in a timely manner to avoid production downtimes

Collaboration and Influencing

  • Work with the Restart Project Team to execute a timely start-up to the Wicklow facility
  • Collaborate closely with EHS, Quality, Operations and Maintenance in supporting problem investigation
  • Act as client Engineering representative on capital projects associated with process plant
  • Be a champion for Health & Safety.

Education and Experience

  • Bachelor’s Degree in Mechanical, Chemical, Process or Electrical Engineering, honors grade.
  • 5 years plus experience in the GMP manufacturing environment.
  • Understanding of GMP and the Quality standards required in the API Manufacturing sector.
  • Experience of the Operation and Maintenance of Manufacturing process systems within a regulated environment
  • Familiarity with Machinery Directive legislation & implementation within an ATEX environment would be an advantage.

Technical skills

  • Familiar with the operation of API process plant including centrifuge, drying, separation, filtration and condensing equipment
  • Experience of leading root cause investigations, deviation reports and CAPA implementation

Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003