Job Description
The Senior Specialist, Project Manager will fill a key role at the Elkhorn facility by development, direct management, and support of medium to large projects ($500K - $85M) 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 Elkhorn 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 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.
Education Minimum Requirement:
- Bachelors Degree in Engineering and 2 -5 years of experience managing projects between $250K and $10M in a highly regulated industry (bio-tech, pharma, food, nuclear or energy) is required.
- - OR - 10 years of direct experience in project management of a medium to large scope in a highly regulated industry (bio-tech, pharma, food, nuclear or energy).
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
#EBRG
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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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, generally Tuesday, Wednesday and either Monday or 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".
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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:
No Travel Required
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
05/15/2024
*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.
Job Posting End Date:05/15/2024
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:R293361
