Process Engineer (Facilities)
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients.
As a growing and successful business, we employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.
Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
- Manage all phases of equipment projects including but not limited to the design, specification, installation, modification, testing, and qualification of laboratory and manufacturing equipment.
- Provide engineering support and problem solving for existing equipment and manufacturing processes.
- Manage technical engineering documents such as SOPs, standards, drawings, etc.
- To comply & adhere to Good Manufacturing Practice (GMP) standards.
Main tasks and responsibilities will include:
- Manage and execute multiple projects of varying sizes and complexity including but not limited to facility remodels, equipment or system installations or modifications, and various capital projects.
- Develop project plans, set objectives, determine key deliverables or milestones, and track progress against the critical path.
- Identify team members, project roles and responsibilities (RACI matrix, project charters, etc.).
- Develop, maintain, and report against timelines and milestones to leadership and key stakeholders (gantt charts, etc.)
- Manage, modify, and maintain engineering technical standards and documentation as it relates to both GxP and non-GxP equipment, facilities, systems, & infrastructure (i.e., drawings, specifications, etc.).
- Meet quality standards while maintaining working knowledge of relevant technologies and best practices while upholding federal and state regulatory requirements.
- Identify and execute a variety of process improvement activities and assist production team resources by helping with production related issues and quality improvement initiatives.
- Support all Environment, Health, & Safety policies and procedures.
- Support and recommend continuous improvement initiatives utilizing lean manufacturing tools and techniques.
- Promote fair and consistent adherence to all local and corporate policies and procedures.
- Performs other related duties as required and assigned.
- The employee is occasionally required to sit, reach with hands and arms, climb or balance, stoop, kneel, and crouch.
- The employee must occasionally lift and/or move up to 50 pounds.
- Bachelor's degree or equivalent required.
- B.S. in Engineering required (i.e., Industrial, Mechanical, Electrical, or Chemical).
- M.S. in Engineering preferred
- Significant experience related to facilities maintenance and/or engineering projects and processes within a regulated industry required (i.e., food, beverage, nuclear, pharmaceuticals, etc.).
- Pharmaceutical or similar experience preferred.
- Oral Solid Dose (OSD) Manufacturing experience is highly desired.
- Project Management experience required.
- Project software experience preferred required (i.e., MS Project, etc.).
- 2-5 years practical CAD experience required.
- TurboCAD or equivalent preferred.
- Experience in managing capital expenditure (CAPEX) projects required.
- CAPEX experience technical laboratory and GMP manufacturing equipment projects is preferred.
- Demonstrated understanding of engineering principles, including mass/energy
- balance, heat transfer, process instrumentation, fluid, mechanical and safety systems.
- Excellent communication and organizational skills are expected.
- Effective use of standard business software, presentation, and reporting skills required (i.e., Microsoft Word, Excel, PowerPoint, Project, and Visio).
- Lean, Six Sigma, and Statistical (i.e., minitab, etc.) experience preferred.
In return, you will receive a competitive salary, a generous benefits package, excellent training, and development, as well as an exciting career within a fast-paced and dynamic business.
Our Commitment to Diversity & Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion.
We strive to create a diverse Quotient family by remaining committed to the development of our culture, equality, mindset, diversity & inclusion in the workplace.
As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. All applicants welcome.
If you have any questions or need some support with your application, we’d love to hear from you so contact our friendly team at email@example.com.