Downstream Process Engineer
- North America, East Coast
- Contract
- Life Sciences
Our client, a global pharmaceutical manufacturing organization are looking for a talented Downstream Process Engineer to join their expanding team. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.
Essential Duties and Responsibilities for this role include, but are not limited to:
- Serves as point of contact to the Engineering, Procurement, Construction Management (EPCM) provider
- Develops and aligns basic plans and provides mitigations, as needed
- Provides direction to detailed design activities in partnership with the EPCM provider
- Writes User Requirements Specifications (URSs)
- Reviews piping and instrumentation diagrams (P&IDs) and other process design documents
- Supports Commissioning Qualification and Validation (CQV), and start-up activities
- Serves as on-call support for process equipment
- Reviews, redlines, and approves P&IDs and other technical documents with limited supervision
- Performs system impact assessments and quality risk assessments for process equipment
- Performs technology transfer (TT) activities related to process equipment
- Requires extensive engineering experience
- Experience in a Life Science or other regulated industry
- Prior experience working in a cGMP environment or other highly regulated industry
- Ability to develop effective working relationships internally and externally
- Effective communication, both written and oral
- Strong problem-solving skills
- Project Management skills
- Ability to effectively present information to others
- Ability to provide standard professional advice and create reports and analyses for review
#LI-NR1
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
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