Job Description

The Capital Projects Technical Lead is responsible for providing project, engineering, and operations support to a bulk manufacturing vaccine facility as well as the Organization at our Company's West Point, PA site.Responsible for process, equipment, and facility projects of varying complexity and size, implementing continuous improvement projects, supporting equipment and investigations as required. Work as an individual contributor, team or project lead.

Accountability:

• Ensure that Area objectives are achieved while reliably supplying quality product at a competitive cost consistent with our Company, Regulatory Agency, and State and Local code requirements for quality, good manufacturing practices, equal employment opportunity, finances, labor, employee, environment and safety.

• Tactical and strategic project management, including collaboration with indirect staff.

• Manages large or multiple small projects with moderate resource requirements, risk and/or complexity. Develops capital plan for End to End and manages portfolio

• Forecasts, plans and monitors costs and headcount requirements for moderately sized projects and/or service level agreements for country/divisional vendors;

Duties:

• Collaborate closely with the IPT and E2E leaders to implement the organization's strategic initiatives, ensuring alignment with the company's overall objectives and the overall our Manufacturing Division strategy.

• Oversees and is accountable for the management, oversight, and successfully delivery of select IPT programs and key initiatives.

• Responsible for process, equipment, and facility projects of varying complexity and size, implementing continuous improvement projects, supporting equipment and investigations as required.

• Supports, executes, and/or leads process, equipment, and facility projects for a vaccine manufacturing organization.

• Supports, executes, and/or leads continuous improvement projects that increase compliance, simplify/standardize and/or gain efficiencies.

• Examines complex issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve the root cause.

• Designs, conducts, and/or reviews and approves experimental protocols as needed.

• Authors, updates, and/or reviews and approves engineering, technical, and manufacturing documents (change control, validation documents, commissioning documents, etc.) necessary for engineering studies and project execution in a GMP environment.

• Supports regulatory and internal audit inspection activities.

• Provides on-the-floor support of complex operational and technical (process/equipment/facility) issues.

• Completes and/or leads projects to improve the performance of our processes, including investigation Corrective/Preventative Actions (CAPAs), projects aimed at improving Right-First-Time performance or preventing/reducing deviations, and value capture projects that seek to improve yield/efficiency, reduce cost, or lower our processing cycle times.

• Supports team safety, environmental, and compliance objectives.

• Manages project timelines to ensure key compliance and customer due dates are met; escalates any potential delays and develop remediation plans when possible.

• Collaborates effectively with the area Coaches, Operators/Mechanics, support groups, Quality, Planning, project teams, and external component and equipment vendors.

• Partners with other sites, divisions, and organizations to evaluate and execute innovative solutions within vaccine manufacturing.

Specific tasks/roles can include but are not limited to:

• Compliance - Responsible for creating and sustaining a culture that ensures that compliance (Safety, Environment, cGMP, etc.) are imperatives for the business. Responsible for establishing a Right First Time culture by reducing waste and constantly driving continuous improvement. Responsible to author, review and/or approve compliance documents, as per procedures or need.

• Work is primarily achieved by individual or through project teams, utilizing technical expertise to achieve results.

• Requires specialized depth of expertise in own discipline and limited knowledge of other disciplines.

• Interprets internal/ external business challenges and best practices to recommend improvements to products, processes or services.

• Solves complex problems; takes a broad perspective to identify innovative solutions.

• Works independently, with guidance in only the most complex situations.

• Acts as a resource for colleagues across multiple areas.

• Lead teams or projects; motivates other team members; promotes value of working together as a team and relationship building, using the diverse perspectives of others to generate ideas.

• Majority of time is spent on: Contributing to and managing projects;

• Providing advice/direction in primary areas of expertise and may manage direct reports;

• Leveraging relationships by interfacing with and influencing key stakeholders to produce optimal results(contributing leader).

Required Experience and Skills:

• Experience in change control, facility/equipment support, or project management role.

• Highly developed communication, leadership, and teamwork skills.

• Ability to manage projects/work to schedule/deadlines.

• Project management for capital projects of varying complexity

• Demonstrated innovative mindset and ability to implement innovative solutions

• Experience in biologics, vaccine, or bulk sterile manufacturing facilities

• In accordance with Policy 82 - 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.

Education Minimum Requirement:

• Bachelor's Degree in Business Administration, Science, Engineering or another technical field.

• Minimum eight (8) years' post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance.

• Concurrently, minimum of (2) years responsibility for direct reports

Preferred Experience and Skills:

• Minimum of (2) years' experience in relevant manufacturing or processing (aseptic/sterile, bulk, solid oral dosage, packaging, etc.).

• Demonstrated knowledge of High Performing Organization tools and methodology, including our Company's Production System/lean processing.

• Demonstrated experience of interacting with site, divisional or regulatory audits.

• Change Control author/reviewer

• Experience with data analytics, coding, and software development

Note: This description is not intended to be all-inclusive or a limitation of the duties of the Job. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

In accordance with Policy 82 - 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.

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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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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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".

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe 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:10/01/2024

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:R314415