Senior Specialist, Engineering

Job Description

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.

Duties and 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.

Education Minimum Requirement: 

• 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.

Required Experience and Skills: 

• 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.

Preferred Skills and Abilities:

• Experience within a USDA regulated manufacturing environment.

• Lean and six sigma skills

• CAD

• CappApp & Connectivity reporting

Required Skills:

Adaptability, 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 {+ 2 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$117,000.00 - $184,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

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.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

03/5/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.