Senior Project Engineer (API Pharma)

Cpl Group

  • Cork
  • Permanent
  • Full-time
  • 29 days ago
LONG TERM CONTRACT ROLE - 5 to 10 YEAR DURATION AT API MANUFACTURING SITEJOB DESCRIPTION POSITION SUMMARY:As part of the Engineering Project Delivery Team, this contract position is responsible for all activities required to support project scoping, commissioning, qualification, validation and start-up operations within the API manufacturing site. These activities include but are not limited to:GENERAL ACTIVITIES:
  • Lead the delivery of Engineering projects on time, on budget & in accordance with all project & business Safety & Quality goals.
  • Scope new Engineering projects & secure Capital approval
  • Lead, support and participate in commissioning and qualification activities both current and future projects.
  • Updating & influencing management and project stakeholders.
  • Coordination of the participation of specialist trades and specialist departments
  • Coordination of project interfaces with other projects and departments
  • Coordination of and interfaces with third parties (suppliers, customers, service providers, etc.)
  • Coordination of project documentation
  • Cost Estimation (creation, tracking, updating, auditing vs actual Costs, forecasting)
  • Project Scheduling (creation, tracking, updating, review vs current state, forecasting)
  • Project progress reporting & Risk Management
  • Constructability- & Maintainability-/Operability-studies
  • Project Resource Management
  • Checking the current condition of systems (structural, E&I as well as safety, permitting and documentation)
  • Organization & coordination of project meetings and appointments
  • Provide project related training as required .
  • Completion of projects in accordance with J&J Change Management Procedures
  • Retrospective project performance review vs project goals and lessons learned.
  • Participate in and lead Cross-Functional teams as necessary.
SCOPE OF RESPONSIBILITIES:
  • Responsible and accountable for assuring the safe accomplishment of job activities, following good environmental practices and procedures. Commit to and demonstrate safe behavior in every activity.
  • Carry out routine and non-routine tasks delegated by the Manager according to appropriate procedures, values and standards .
  • Carry out all activities in compliance with corporate and cGMP/EHS regulatory requirements.
  • Compliance with Engineering and general site procedures at all times
  • Completion of all documentation in compliance with site procedures and GDP
  • Prioritize and schedule activities to support business needs
  • Ensure that personal training requirements are completed in compliance with site procedures .
  • Support ongoing studies by Operations, Quality Validation, MSAT, Facilities and other support functions .
  • Support external site visits as required for project related activities.
  • Lead by example and strive to perform to high standards at all times.
LEADERSHIP RESPONSIBILITIES / INDIVIDUAL CONTRIBUTION:
  • Report to Principal Project Delivery Engineer/Engineering Manager
  • Be familiar with daily activities in all areas of Manufacturing .
  • Facilitate an environment of continuous improvement.
  • Facilitate an environment of open communication.
  • Lead investigations in work area as necessary .
  • Lead Cross-Functional project teams to support site goals .
  • Collaboration and teamwork
  • Initiative and motivation
  • Share ideas and suggestions for improvement and encourage others to do the same.
  • To work as a strategic partner with all other departments within the company.
ORGANISATIONAL INTERFACES:Interface at with all site departments, Operations, Maintenance, Facilities, Quality, MSAT, Commissioning/Qualification and Training departments. Contact with other J&J sites . Be conscious of internal customers to Engineering department and work to fulfill their requirements.QUALIFICATIONS AND EXPERIENCE:ESSENTIAL:
  • Third level qualification in Engineering, Microbiology, Biochemistry, Biotechnology, or Science.
DESIRABLE:
  • Experience of delivering engineering projects within a GMP regulated environment.
  • Qualification in Project Management
  • Experience of Microsoft Word, Excel and Outlook
  • Experience of SAP, LIM's and/or other business systems
  • 6-Sigma/Kepner-Tregoe or similar problem solving/decision making methodology training
  • Experience of working within an Engineer team in a multinational corporate environment.
KEY COMPETENCIES REQUIRED:
  • Ability to operate as part of a team is critical.
  • Excellent Interpersonal Skills
  • Customer focus
  • Innovative
  • Mechanical/Technical aptitude
  • Excellent communication skills both written and verbal.
  • Attention to detail.
  • Good problem-solving skills.
  • Results and performance driven.
  • Adaptable and flexible
SIGNIFICANT ENVIRONMENTAL, HEALTH & SAFETY CONSIDERATIONS:All employees are required to comply with the requirements of the company's Environmental, Health & Safety Policy, Safety Statement, associated EHS Procedures, local legislation and duties outlined in the site EHS Manual. In line with the Safety Health & Welfare at Work Act, all employees are required to:
  • Take reasonable care to protect his or her own and the safety of their colleagues who may be affected by their actions.
  • Compliance with EHS rules and procedures at all times.
  • Understand the potential EHS impact of their activities.
  • Attend and participate in EHS training as required.
  • Use PPE and safety equipment as required.
  • Report all incidents, accidents, and near miss events.

Cpl Group