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POSITION SUMMARY:
This role reports to the Rathdrum Site Technical Engineering Lead and will assist with activities associated with the Rathdrum site s core plant equipment. The objective is to ensure the highest levels of safety and availability of plant equipment and compliance with the company and regulatory standards.
Primary accountabilities are
The role will report to the site Technical Engineering Lead and will have a strong relationship with the site Maintenance, Projects, Operations, Quality and EHS functions.
POSITION RESPONSIBILITIES :
Compliance
Ensure company, and 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 walk downs
Work closely with EHS, Operations, 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 plant equipment are maintained and updated as required
Act as Client representative for interactions with project delivery teams and OEM s in relation to Machinery Directive and risk assessments for 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 plant equipment reviews and upgrades are implemented in a timely manner to avoid production downtime
Collaboration and Influencing
Work with the Restart Project Team to execute a timely start-up to the Rathdrum facility
Collaborate closely with EHS, Operations and Maintenance in supporting problem investigation
Act as client representative on capital projects ref plant and utility scope
Be a champion for Health & Safety for the company
Support the implementation of corporate global policies, site and business specific guidelines and manufacturing SOPs
ORGANIZATIONAL RELATIONSHIPS
Directly reports to the Utilities & Equipment Lead.
Strong working relationship with other functional areas such as Maintenance, Projects, Automation, Operations, Quality and EHS
EDUCATION AND EXPERIENCE
Bachelor s Degree in Mechanical or Electrical Engineering, honors grade.
3 years plus experience in GMP manufacturing environment.
Understanding of GMP and the Quality standards required in the API Manufacturing sector.
Experience of the Operation and Maintenance of Manufacturing & Utility systems within a regulated environment
Experience of Machinery Directive legislation & implementation within an ATEX environment would be a distinct advantage
Financial Accountability
Supporting the capital budget development related to plant equipment
Oversee external support companies for on-site work scopes and ensuring cost adherence
TECHNICAL SKILLS and COMPETENCIES REQUIRED
Excellent oral and written communication skills report writing skills
Analytical approach, demonstrated problem solving skills, comfortable with use of spreadsheets
Ability to collaborate with and influence colleagues
Attention to detail, strong appetite for learning, ambitious
Full Time