Senior Specialist, Engineering – GES Tech Center

Job Description

Our Engineers support internal and external manufacturing operations remain operational, continuously improve, and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

The Senior Specialist operates under the guidance of the Technology Director supporting the Large Molecule Line of Business with focus on a growing portfolio of work in GES’ Northeast Region.  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 leading the planning, design, and implementation of engineering solutions on a suite team within a large capital project or leading small capital projects less than $100MM in value.  Core work includes equip/scope generation, process & facility design, equipment selection, vendor interaction, factory acceptance testing, technology transfer, construction support, equipment qualification, facility start-up and process demonstrations. The role may involve supervising junior engineers and collaboration with resources from an engineering firm.

The Senior Specialist primary responsibility entails:

• Exhibiting strong technical/engineering leadership, interpersonal, collaboration and communication skills for both decision making and guiding team members.
• Leading a cross functional suite team of 5-10 members through the stage gates of a project and setting them up for success with knowledge transfer.
• Ensuring deliverables conform to our company's standards and practices; and are technically sound.
• Providing technical guidance during project implementation, assures viability of technology to meet design intent.
• Collaborating with other technical functions to ensure successful technology transfers of new and in-line products.
• Flexibility with travel up to 35%.

This position will function as the technical/engineering process lead engineer/project design manager with prior experience supporting Biologics, Vaccine and/or Sterile Projects and Drug Product manufacturing.

Minimum Education Requirement and Experience:

• Bachelor of Science (B.S.) degree in Engineering (Chemical or Mechanical), Science, or Business with five (5) years of experience in Pharmaceutical/Biotech industry such as Process-Equipment Engineering Design, Capital Project implementation, Technical Operations, or Operations/EMU. OR
• Master of Science (M.S.) degree in Engineering (Chemical or Mechanical), Science, or Business with three (3) years of experience in Pharmaceutical/Biotech industry such as Process-Equipment Engineering Design, Capital Project implementation, Technical Operations, or Operations/EMU.

Required Experience and Skills:

• Three (3) years’ experience leading cross functional teams in the startup and C&Q execution of capital projects.
• Drug Product filling experience – start up, operation, troubleshooting of filling equipment.
• Experience with an equipment life cycle approach including specification, selection, testing & commissioning, troubleshooting and qualification.
• Understanding of hygienic design and unit operations specific to vaccine/biologic manufacturing and aseptic processing in the areas of Buffer Prep, Formulation, and CIP/SIP.
• Experience with capital projects that followed a stage gate capital management process.
• Excellent collaboration and engagement as a team player with dependable interpersonal and communication skills.
• Analytical and problem-solving skills.
• Multitasking/time management skills which deliver on time and quality work.
• Core knowledge should include specification of unit operations, P&ID reviews, Hazard Analysis, equipment operation, commissioning & qualification execution.
• Work independently and meet timelines in a fast-paced team-based environment.
• Strong self-motivation; proactive, high-energy, "can do" work ethic; ability to handle potentially stressful situations with a positive attitude.

Preferred Experience and Skills:

• An advanced degree in Engineering, Science, or Business is preferred.
• Possess experience with engineering design, equipment operation and startup, and managing the growth and development of ju