What are the responsibilities and job description for the Project Engineer position at PSC Biotech?
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in California, employing a global team of skilled professional and experts that span across strategically located offices in the United States, Europe, Asia, and Australia. PSC operates in 52 countries globally and has served thousands of clients to date.
We focus on providing GMP professional consulting services in the Life Sciences Industry to ensure our client’s success. PSC provides exceptional technical capabilities and customer service to our clients for all projects ranging from equipment qualification to large scale greenfield Commissioning, Qualification and Validation (CQV) projects. We understand that the world of life science is evolving rapidly, so we are on the front-line providing GMP expertise and innovative products to meet our customer’s expectations.
We are looking for a Project Engineer. The ideal candidate should have at least 2-5 years of experience.
Responsibilities
- Responsible for providing engineering support to project managers and stakeholders.
- Manage and execute CQV projects in the GMP Biotechnology industry.
- Equipment and Facilities CQV activities
- Project life cycle activities for greenfield sites
- End to End project management, including design, procurement, construction, installation through to commissioning and qualification
- Equipment / systems selection – develop and document equipment / system requirements, assess alternative solutions, and contribute to CAPEX / CPR preparation and submission with GMP.
- Facilities and utilities management - design, modification, installation, and commissioning.
- Equipment validation - develop validation / commissioning documentation and be involved in the installation and qualification of new equipment.
- Work closely with the Project Manager and all cross-functional groups to set up and execute and testing.
- Ensure compliance with Quality Management System.
- Manage quality objectives, regulatory requirements, schedules, and program risks and make decisions based on business objectives.
- Liaise with Department Managers, Site SME’s and external suppliers with in GMP industry.
Requirements
- BS Degree in Mechanical, Electrical, Chemical or Biomedical Engineering or equivalent
- 2-5 years relevant project or engineering experience
- 1-2 years’ experience in GMP Manufacturing Facilities
- Experience in a Greenfield/Brownfield projects, highly desirable.
- Exceptional interpersonal skills to communicate effectively and build relationships with a broad spectrum of audiences at all organizational levels.
- Strong competencies in planning, project management, and organization with the ability to lead multiple activities and resources while maintaining a focus on quality.
- Bio process equipment experience plus knowledge of ISO, TGA, FDA and other regulatory standards, preferred
- Strong written and verbal communication skills
- Experience with Excel and MS Project
