Project Engineer
7 days ago
- Generate User Requirement Specifications (URS), Risk Assessments (RAs), to select and oversee procurement of utility equipment, facilities and services.
- Organise and lead design and stage-gate reviews to ensure delivery of appropriate, reliable and safe equipment/utilities to support commercial manufacture.
- Work within the project team to engage with design consultants, construction managers and sub-contractors to develop, review and finalise project scope.
- Input into and/or lead modelling and feasibility assessments.
- Provide technical support from project definition through to commercial manufacture.
- Ensure related maintenance, calibration, validation and all project activities comply with safety (regulatory and Pfizer) standards.
- Provide periodic project updates and present to site leadership as necessary.
- Ensure the systems are maintained in a GMP compliant state and that GEP as robustness, reliability, safety and efficiency apply.
- 5 years industry experience as a project engineer in a manufacturing organisation.
- A technical degree in a field that is related to Pharmaceutical Manufacturing. A Masters or Doctoral degree is not required but is preferred.
- Extensive experience with packaging and inspection technology in a pharmaceutical setting
- Project Management experience, training or certification (Preferred) Experience in a Pharmaceutical environment/ sterile injectable (Preferred) Delegation & Leadership Skills
- Financial management and procurement competency.
- A growth mindset and a drive to continue learning every day.
- A clearly demonstrated awareness of the importance of EHS, particularly Safety.
- Will deliver on commitments, particularly agreed timelines, budget, quality and scope.
- A proactive approach, a self-starter with an ability to deal with ambiguity.
- A collaborative approach and ability to work in a team environment.
- A willingness to challenge the status quo, investigate and consider alternatives.
- A good understanding of cGMP principles and requirements.
- Ability to communicate and influence key stakeholders.
- Ability to communicate effectively to all levels of the business.
- The perspective to understand and appreciate business goals beyond immediate team or project.
- Ability to manage involvement in multiple projects at same time
- An openness to critical feedback and personal development. Excellent written and verbal skills.
Pfizer
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