Senior Specialist, Project Management

Job Description

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.

Duties and Responsibilities:

Capital Project Management:

• • 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.

Process Support:

• • 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.

Compliance Subject Matter Expert:

• • 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.

Minimum 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)

Required Skills/Abilities or Special Requirements:

Computer

• 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.

Physical

• 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.

Other

• 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)

Preferred Skills and Experience:

• 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

Required Skills:
Capital Projects, Microsoft Project, Project Budget Management, Project Forecasting, Project Management, Project Reporting

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:

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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
$104,200.00 - $163,900.00

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:
Yes

Hazardous Material(s):
N/A

Job Posting End Date:
02/9/2026
*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.

Requisition ID:R379510