Skills: Process Engineer
Experience: 15 + Years
Education: Bachelors/3-5 yr Degree
Location: Greenville, South Carolina, United States
Wood is currently seeking a Senior Process Engineer to work as part of a world class program management team for a major new pharmaceutical production campus. The team will represent the Owner in the Concept Design and Basis of Design phases, later followed by detailed engineering/design, Construction, Commissioning and Validation, necessary for the establishment of certain drug substance manufacturing facilities and capabilities, certain drug product manufacturing and finished goods facilities and capabilities, along with certain related and ancillary facilities. The lead process engineer must demonstrate experience in delivering projects for typical biopharma production processes (MAb, microbial and vaccine), with experience on either bulk manufacturing, fill/finish, or both.
- Representing Owner reviewing Consulting Engineering firms work and deliverables including process flow diagrams, piping and instrument diagrams, process timelines, utility analysis and summary, priced equipment list, equipment data sheets and specifications as well as equipment bid evaluations, process descriptions, relief calculations, safety review documents, and instrumentation/automation sequences
- Provide input to strategic development, master planning, execution planning, and general process engineering services to the Project
- Provide support to the Project, as required, in the areas of technical and relevant subject matter expertise related to Drug Substance and Drug Product Manufacturing.
- Provide support to the Project in other aspects of project management such as change control, planning management, progress measurement, design reviews, oversight of technical package development and input to development of procurement/contracting strategies
- Interface with Project leadership and other contractors supporting the Project (including any EPC and/or general contractor that may be selected) during conceptual design, basis of design, and potentially later during detailed design, equipment procurement, contracting, construction, commissioning, cGMP acceptance testing, and/or other phases of the Project.
- Work closely with the project manager to ensure scope, schedule, budget, change control, and quality parameters are met on the project
- Overseeing the preparation of technical specifications for purchased equipment, as well as coordination with equipment suppliers and evaluation of suppliers' proposals
- Provide oversight of general contractor's project, engineering, technical procurement and construction management activities with an emphasis on the Project's aims and specifications relating to quality, cost, and schedule, and inform FDBU of issues and concerns as they arise and troubleshoot the same.
- Manage the Owner's drivers for the project, which include capital cost, life-cycle cost, impact on current operations, quality, and schedule
Skills / Qualifications
- Bachelor's degree in chemical or mechanical engineering, or pertinent degree and experience
- 15+yearsof experience in a similar role in large pharma/biotech projects.
- Experience with initial phases in project (CD/BoD) - preferably working in the owner's organization
- Must have focused design experience in the pharmaceutical and biotechnology industries, especially in antibody, microbial or bulk vaccine processes, as well as plant and process utilities; Experience should include bulk manufacturing and/or fill/finish experience
- Experience in a cGMP facility or working with FDA regulations
- Experience representing Owner reviewing Consulting Engineering firms work and deliverables including process flow diagrams, piping and instrument diagrams, process timelines, utility analysis and summary, priced equipment list, equipment data sheets and specifications as well as equipment bid evaluations, process descriptions, relief calculations, safety review documents, and instrumentation/automation sequences
- Demonstrated understanding of interactions between Process design with MEP design efforts
- Ability to collaborate with project team members, Consulting Engineering firm's team and client entities, demonstrating the leadership capabilities to insure a successful project
- Demonstrated experience working with equipment vendors to provide optimum solutions to equipment design that will meet or exceed client expectations
- Capable of reviewing the process design and its coordination with the piping model
- Excellent written and oral skills are required
- Experience with "sizing" in the Conceptual Design / BoD phases will be important - i.e. sizing of QC labs, warehouses etc
Authorization to work lawfully in the US without sponsorship from Wood is required .
Wood is a global leader in engineering and consultancy across energy and the built environment, helping to unlock solutions to some of the world's most critical challenges. We provide consulting, projects and operations solutions in more than 60 countries, employing around 45,000 people. www.woodplc.com
We are an equal opportunity employer that recognises the value of a diverse workforce. All suitably qualified applicants will receive consideration for employment on the basis of objective criteria and without regard to the following (which is a non-exhaustive list): race, colour, age, religion, gender, national origin, disability, sexual orientation, gender identity, protected veteran status, or other characteristics in accordance with the relevant governing laws.
Wood is a global leader in the delivery of project, engineering and technical services to energy and industrial markets. We operate in more than 60 countries, employing around 55,000 people, with revenues of over $11 billion. We provide performance-driven solutions throughout the asset life cycle, from concept to decommissioning across a broad range of industrial markets including upstream, midstream and downstream oil & gas, chemicals, environment and infrastructure, power & process, clean energy, mining, nuclear and general industrial sectors. We strive to be the best technical services company to work with, work for and invest in.