Senior Specialist, Engineering

MSD•Wilmington, DE

3d•Hybrid

About The Position

The Senior Specialist operates under the guidance of a Director or an Associate Director in the Global Engineering Solutions team supporting Technology Center, Large Molecule Process Engineering. The individual collaborates with other Integrated Project Team (IPT) members (e.g., Project Management, Technology, Maintenance, Automation, Plant Operations and Safety), Engineering Firms and Vendors to progress deliverables. The Senior Specialist would be responsible for, but not limited to: Planning, design, and implementation of capital projects including scope generation, Process & facility design, Capacity Assessments, Equipment selection, Vendor management and interaction, Factory acceptance testing, Facility start-up and Commissioning, Construction support and/or management, Equipment qualification, Technology transfer, Process demonstration. Candidates possessing capital management experience or expertise are preferred for this role. Ideal candidate will possess superior communication and technical skills, a team player with the ability to work independently. We are seeking candidates with outstanding records of achievement and demonstrated leadership abilities, candidates who are analytical and inquisitive about the interrelationships of various components, and perceptive, quick learners committed to making a difference in the pursuit of manufacturing high-quality, market-leading pharmaceutical, biologic and vaccine products. The candidate should have a strong understanding of the line of business, understand MPS principles and how to apply them to design and delivery, implement standard work and be able to lead technical areas and small capital projects from an end to end perspective. Position is project-based, requiring on-site support 5 days per week, for up to 3 years. Flexibility with travel up to 50% and work location is also required based on project need.

Requirements

Minimum of four years post-bachelor’s degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations (consideration given to advanced degrees)
Minimum of two years project leadership and/or management
Written and verbal communication, leadership and teamwork skills.
Experience with engineering design, equipment start-up and operation, vendor interface, risk assessment and process safety
Ability to travel, both domestic and international
Bachelors Degree or higher in Mechanical, Chemical, BioChem, BioMech, or Computer/Electric Engineering or Applicable Science
Antibody Drug Conjugates (ADC)
Bioconjugation
Capital Projects
Change Control Processes
Customer-Oriented
Deviation Management
Engineering Design
Engineering Standards
GMP Compliance
Good Manufacturing Practices (GMP)
Maintenance Engineering
Manufacturing Process Validation
Oral Communications
Process Optimization
Process Safety
Project Leadership
Project Management
Regulatory Compliance
Root Cause Analysis (RCA)
Strategic Thinking
Teamwork
Technical Support
Technical Transfer

Nice To Haves

Capital management experience or expertise
Downstream Process Engineering and Bioconjugation.
Estimating and/or Project Controls experience or expertise
Capital Management Process Experience
Experience with equipment life cycle approach including specification, selection, testing & commissioning, troubleshooting and qualification
Construction Management Experience
Experience with OEB5 potent compound manufacturing, Antibody Drug Conjugates (ADCs), process safety, and industrial hygiene.

Responsibilities

Planning, design, and implementation of capital projects including scope generation
Process & facility design
Capacity Assessments
Equipment selection
Vendor management and interaction
Factory acceptance testing
Facility start-up and Commissioning
Construction support and/or management
Equipment qualification
Technology transfer
Process demonstration