Senior/Principal Engineer for the Large Molecule Drug Substance (LMDS) project.
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.
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.
Required Skills:
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.
Education:
Minimum of a Bachelor's or equivalent University Degree required in Chemical or Mechanical Engineering
MS/MBA/Ph.D. PE Certificate preferred Experience and
Skills:
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.
About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com. US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring.
Numbers & Facts
Location
Wilson, NC
Skills
Analysis Skillsunmatched
Automationunmatched
Business Administrationunmatched
Business Developmentunmatched
Business Skillsunmatched
Business Solutionsunmatched
Capital Expenditure (CAPEX)unmatched
Chemical Engineeringunmatched
Communication Skillsunmatched
Conflict Resolutionunmatched
Constructionunmatched
Cross-Functionalunmatched
Customer Relationsunmatched
Detail Orientedunmatched
Engineeringunmatched
Facilities Engineeringunmatched
GMP (Good Manufacturing Practices)unmatched
Leadershipunmatched
Manufacturingunmatched
Manufacturing Engineeringunmatched
Manufacturing Requirementsunmatched
Manufacturing Systemsunmatched
Manufacturing Technologyunmatched
Material Take Offunmatched
Mechanical Engineeringunmatched
Operational Supportunmatched
Process Engineeringunmatched
Process Improvementunmatched
Process Manufacturingunmatched
Professional Engineerunmatched
Project Planningunmatched
Quality Engineeringunmatched
Regulatory Requirementsunmatched
Risk Managementunmatched
Standards Developmentunmatched
Startupunmatched
System Start-Upunmatched
Team Playerunmatched
Technical Leadershipunmatched
Technical Operationsunmatched
Technical Supportunmatched
Technical/Engineering Designunmatched
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