Senior Specialist, Engineering

MSD•Millsboro, DE

1d•$117,000 - $184,200•Hybrid

About The Position

The Senior Specialist, Project Manager will fill a key role at the Millsboro facility by development, direct management, and support of medium to large projects ($500K - $20M) according to site and corporate engineering, safety, environmental, quality, and code requirements. The position will be responsible for developing scope/budget documents, funding requests, project schedules, as well as managing design, execution, commissioning, qualification, and delivery activities of capital projects at the Elkhorn site. The Senior Specialist, Project Manager, will focus on biological production related projects including, bacterial and cell fermentation, down stream processing, biological containment, decontamination, sterile filling, freeze drying, and packaging operations. The Project Manager will also execute projects related to critical utility systems serving the production operations. This exposure will make the Project Manager a key expert on many of the systems serving the Millsboro site, and thus the Project Manager will routinely be asked to serve as a site liaison at our Company facilities in the US, and around the world. There will be less than 5% travel expected for the role as needed.

Requirements

Bachelors Degree in Engineering and 10 years of experience managing projects between $250K and $10M in a highly regulated industry (bio-tech, pharma, food, nuclear or energy) is required.
Possess strong problem-solving skills and able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve it at root cause
Ability to read and interpret technical/engineering documents, drawings, schematics
Strong verbal and written communication skills
Expertise and proficiency with basic office computer software, and the ability to learn how to effectively use SAP maintenance software to input data, research parts and analyze repair history detail.
Must be able to be exposed to extreme temperatures, outside weather in all conditions, high noise environments, work areas near moving mechanical parts and any chemicals used in production process.
Communication, leadership, and teamwork skills.
Adaptability
Customer Relationship Development
Deviation Investigations
Facility Management
Failure Mode and Effects Analysis FMEA
Functional Requirements
HVAC Systems
Identifying Customer Needs
Industrial Hygiene
Interpersonal Relationships
Lean Six Sigma Tools
Manufacturing Quality Control
Occupational Hygiene
Production Operations
Production Support
Project Budgeting
Project Management
Project Management Support
Purchase Orders
Regulatory Compliance
Root Cause Analysis (RCA)
Schedule Development
Strategic Thinking
Technical Interpretation

Nice To Haves

Experience within a USDA regulated manufacturing environment.
Lean and six sigma skills
CAD CappApp & Connectivity reporting

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.
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 Assessments by contractors during construction, and by End Users as projects are turned over.
Attend and execute Equipment Vendor Factory Acceptance Testing and Site Acceptance Testing.
Oversee EPCMs, contractors, vendors 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.
Help create and align the vision of the site through Master planning activities and align those in the LRCP through multiyear investments.
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.

Benefits

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.

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