Principle Engineer  (Conshohocken, PA)
Plant Construction and Commissioning Engineer
Pharmaceutical Project Engineer, Commissioning and cGMP Validation.

Our client in Pharma, located in Conshohocken, is currently hiring 3 Principle Project Engineers to build and assist with green plant (green or brown plant experience may be accepted). Engineers will oversee the construction, installation, and commissioning of equipment, systems, and processes while ensuring they meet regulatory standards for pharmaceutical production. 

Incumbents will develop business based technology solutions and provide integrated equipment, utility, and facility engineering expertise with an operational focus to support execution of strategic and key CAPEX manufacturing projects, driving ‘right first time’ start up and execution. One Engineer will be placed in in upstream, one in downstream and the third on support/utilities. General skills all candidates should have: Large Molecule, Biologics, A&E, P&ID, FAT, SAT, C&Q, Delta V & GMP (cGMP).

Roles are 3 plus year Contracts (at least through 2028), and will require travel between Conshohocken, PA and the Southeast US (relocation to Southern U.S. may be expected). 

Position summary:
Support the deployment of the MTO aspiration “to innovate to safely supply quality products and services competitively, faster, always”. Responsible for providing advanced engineering design and start-up of GMP large molecule biologics manufacturing facility systems, and equipment. Provide integrated equipment, utility, and facility engineering expertise with an operational focus in support of technology transfer and manufacturing projects to support ‘right first time’ execution and start up.
Drive innovative solutions in engineering support, and process technology. Coordinate with Technical Operations platform to ensure project alignment with technology standards and engineering specifications for manufacturing technology. This is intended to be a general job description and should not be construed as all-inclusive.

Key Responsibilities:
Extensive interaction with external partners (A&E, construction firms, equipment vendors) to develop, organize and execute project plans as SME and process systems owner. The incumbent should demonstrate the following: detail and goal oriented, teamwork, customer-focus, thorough understanding of GMPs and regulatory requirements.
Serve as Process Engineering Expert to develop business based technology solutions and provide integrated equipment, utility, and facility engineering expertise with an operational focus to support execution of strategic and key CAPEX manufacturing projects, driving ‘right first time’ start up and execution.
Provide strong technical leadership and expertise for technology transfers and new technology development projects to ensure process fit to plant methodology and practices..
Explore and understand Technology and Manufacturing challenges and synthesize business needs, manufacturing requirements, engineering elements, and technology inputs, etc. into business solutions.
Provide technical leadership of multi-functional teams on many projects/ process improvements and resolves inter-functional issues.
High degree of collaboration with internal (manufacturing, quality, engineering) to develop standards and define project needs and priorities; as well as recruiting project team members.
The incumbent must also have a thorough understanding of business requirements, effective communication skills, leadership, and interdependent partnering, conflict and risk management.

Qualifications:
Minimum of a Bachelor’s or equivalent University Degree required. MS/MBA/Ph.D. or PE Certificate preferred.

Experience and Skills:
New plant Construction- cGMP, pharmaceutical. A Principle Engineer from an A&E firm with pharma would be ideal, Design of facility, ideal. 
Other desired titles: Pharmaceutical Project Engineer, Pharmaceutical Facilities Engineer; Process Engineer,  Pharmaceutical Manufacturing, Plant Construction and Commissioning Engineer, Project Manager – Pharmaceutical Engineering, Pharmaceutical Engineering Lead, Pharmaceutical Plant Design and Commissioning Engineer.
Key Skills: Large Molecule, Biologics, A&E, P&ID, FAT, SAT, C&Q, Delta V & GMP (cGMP).
A minimum of eight (8) years of process/plant engineering experience in GMP MFG large molecule biologics facilities.
Experience in green or brown field GMP MFG facility start-up including process systems, automation, utilities, facilities and operations.
Strong technical background in Process and Manufacturing engineering, strong analytical skills to synthesize business needs, manufacturing requirements, engineering elements, and technology inputs, etc. into business solutions Operational and financial fundamentals.
The ability to lead and/or support multiple projects simultaneously.
Defines technical or scientific direction of programs composed of multiple complex projects.
Engineers new and modifies existing processes to ensure right first time process start up.
Track record of successful program execution and team outcomes.
FPX certification and Six Sigma and/or Lean experience are a plus.

Client is responsible for supplying medicines to markets around the world. They strive to provide access and affordability of healthcare, through innovation, to deliver life changing solutions for all patients in need. 

Fully-benefited Contract. Premium Benefits.

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