Job Description
Project Engineer – New Syringe and AVI Lines Operations Readiness
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide.
We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.
Employees are the "heartbeat" of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression.
The Project Engineer – New Syringe and AVI Lines Operations Readiness will report to the Operational Readiness Programme Lead within the Operations Function.
They will be responsible for providing project management and engineering support for projects in the Operations Readiness Programme for the new syringe and AVI lines.
The successful candidate will have five to eight years of experience within the pharmaceutical or biotech industry and will have demonstrated project management skills.
Key Responsibilities:
- Arrange agreement among the project team, customers, and management on the goals of the project.
- Work with workstream leads to develop and maintain the Project schedule/plan that aligns with the overall goals of the Programme.
- Effectively communicate with everyone involved in the project.
- Have a controlled scope in place, which is understood by all stakeholders and maintained throughout completion of the project.
- Execute prudent risk and issue management.
- Maintain Actions/Risk and Decision logs.
- Generate and own the GMP change control.
- Motivate, support and direct project team members to deliver on project plan.
- Lead Team meetings and cross-functional collaboration.
- Work with resource managers from across the organisation to effectively obtain and allocate resources to complete programs and projects on time.
Compliance Related Tasks:
- Ensure compliance to c GMP
- Ensure safety & compliance standards are maintained to the highest standards.
- Ensure financial compliance in line with Business & Financial guidance.
- Support a culture of personal responsibility within reporting structure.
Requirements:
- High Energy and Commitment
- Ability to work independently.
- Comfortable leading across multiple stakeholders & multinational teams
- Strong ability to influence and affect change.
- Capable of resolving issues of conflict effectively
- A proven track record to transfer goals and objectives into measurable plans.
- Ability to identify gaps/risks and put appropriate remediation plans in place.
- Uses strong relationships to identify requirements and potential opportunities.
- Employs project management techniques and Problem Solving
- Provides leadership, guidance, and advice in own field of project management.
- Knowledge or experience with MES and EMBR projects
- Knowledge or experience with validation of Aseptic Filling Lines
Qualifications and Experience:
- Technical Degree and/or Masters' or equivalent
- Experience in a Life Science / Pharmaceutical / Biotechnology Environment
- Preferred Experience: Project Engineering & Management, Aseptic Filling Line Operations, MES/EMBR, Validation, Greenfield / Brownfield start up.
Systems / Equipment:
- MS Office, MS Project, MS Power Point, and MS Visio