Senior Specialist, Project Management

Merck • Elkhorn, NE

8h

About The Position

The Senior Specialist, Project Management will be responsible for production process focused capital improvement projects. The role will be an engine to improve process efficiency, adherence to product requirements, cost base management, and return on investment. A detailed approach and extensive experience in the biopharmaceutical environment are critical precursors to this role’s success. The Senior Specialist, Project Manager will develop, execute, and close multiple projects at a time, and will be required to keep many initiatives and efforts in flight concurrently.
Background for this role will include hands on and in-depth experience in fermentation, cell culture, centrifugation, crossflow filtration, sterile filling, freeze-drying, and packaging. The Senior Specialist will use their expertise to deliver tightly specified, well scoped, controlled delivery, ready for production projects on existing, used, and new equipment/process systems. Initiatives driving this role will include Safety, Quality, Efficiency, and Reliability improvement. The Senior Specialist will wear Subject Matter Expert hats in each of these disciplines and will support company and regulatory responsibilities and be an engine for the site’s drive toward competitive and compliance excellence.

Requirements

• Bachelor's Degree in Engineering Required (Chemical, Biological Systems, or Biomedical Engineering disciplines are preferred)
• 5+ year of experience managing projects between $250K and $10M in a highly regulated industry (biotech, pharma, food, nuclear) is required.
• Direct experience with Commissioning, Qualification, and Validation of biotech equipment systems.
• Ability to drive a car and perform limited travel is required (5% or less).
• Excellent knowledge of Industrial and Construction Safety (OSHA 10 training required, OSHA 30 preferred)
• Knowledge of PC use and ability to use various software programs as required.
• Advanced level knowledge of MS Office (Excel, Word, Outlook, etc.) required.
• Use of MS Project Professional required.
• Ability to use various handheld measuring devices.
• Ability to sit, stand and walk for up to 8 hours or more per day.
• Ability to lift and carry up to 50 lbs. on a limited basis.
• Climb stairs and ladders to access equipment components during construction, installation, testing, or qualification phases of a project.
• Ability to work at a computer to accomplish requirements above.
• Capable of working in unconditioned spaces at times.
• Limited off shift work may be required to meet project, operations, and qualification needs.
• Ability to support annual shutdowns for 9 days each June, and 5 days each December or January( based on business needs)

Nice To Haves

• Experience with Project Management computerized tools such as Oracle Primavera, Planview, EcoSys etc.
• Project spending and completion forecasting
• Experience with project financial management, including budget development and cost control

Responsibilities

• Develop, Specify, and Manage project scopes and deliverables according to the requirements of Global and Site Engineering, Safety, and Quality requirements.
• Develop Preliminary Project Schedules in MS Project and manage the development of project schedules throughout the life span of each project.
• Develop Project Budgets and Forecasts, and track performance of each project throughout the life span of each project.
• Open and track Quality Change Requests related to project scopes.
• Open and track Safety Management of Change (MOCs) change requests related to project scopes.
• Coordinate and manage Process Hazard Analysis execution and Action Plan completion in support of projects.
• Coordinate and manage Ergonomic, Industrial Hygiene, and other safety related assessments and resulting Action Plans in support of projects.
• Develop Project Intake documents to gain project alignment for project activities.
• Attend and execute Equipment Vendor Factory Acceptance Testing and Site Acceptance Testing.
• Oversee contractors and consultants to deliver projects as agreed with customer groups.
• Develop User Requirement Specifications (URS), Functional Requirement Specifications (FRS), and Detailed Design Specifications (DDS) for small projects; and manage the development of these document packages for larger projects.
• Review and approve URS, FRS, and DDS specifications developed by outside providers.
• Lead project team meetings.
• Define and develop customer supplied justification expectations.
• Issue purchase orders and change orders to suppliers.
• Monitor, verify, and approve supplier invoicing.
• Close out projects when complete and assign depreciation profiles in cooperation with Accounting and Finance.
• Work with customers to develop User Requirement Specifications for project and change control activities.
• Develop and execute, or in some cases contract development and execution of Commissioning, Qualification, and Validation protocols for testing of system changes and upgrades.
• Train user groups on the efficient and effective use of their system interfaces and required applications.
• Develop and update or manage the development SOPs to support project deliverables.
• Develop and update or manage the development of Energy Control Procedures to support project deliverables.
• Manage development and use of Job Safety/Hazard Assessments by contractors during construction, and by End Users as projects are turned over.

Benefits

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
• We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level