Job Description

The incumbent will be part of the Incoming Materials Technology-Components Center of Excellence (CoE) within the Global Science and Technology Services organization. The Incoming Materials Technology-Components CoE is technical focused group that has global responsibility for Single-Use Technology (SUT) as well as Primary Packaging and Device Components. The incumbent will provide technical leadership for the design, sourcing, and operational support projects as well as lifecycle management of primary packaging and device components.

The incumbent could be called upon to provide technical leadership (i.e., design, sourcing, and operation support projects) for SUT based on business needs. This role will require collaboration and global coordination of work across Technology, Operations, Quality, Supplier Development & Performance Management, Planning, Procurement, and Regulatory. Responsibilities contain technical, regulatory, and business elements.

The incumbent will be responsible for projects and activities related to sterile product packaging and device components including vials, vial stoppers, syringe barrels, plunger stoppers, cap/seals, and plunger rods as well as future technology such as autoinjectors, etc. Areas of focus will include support for new component selection, sourcing, and implementation; deployment of standard components and practices; assistance with component related investigations; process and productivity improvement projects, and supplier notification/change management. Based on business needs, the incumbent may support comparable activities for SUT.

Responsibilities include, but are not limited to, the following:

• Act as a global Subject Matter Expert (SME) for primary packaging and device components; this expertise must span the component supplier manufacturing processes through our Company manufacturing processes

• Develop standards and practices to resolve and avoid component problems

• Coordinate activities and provide technical oversight with suppliers to improve the quality and supply of components as well as participate in business and relationship meetings

• Evaluate supplier notifications for impact to our Company business; generate required documentation in change control systems and support related site activities

• Evaluate compendia updates for impact to our Company business; generate required documentation in change control systems and support related activities

• Lead assessments to identify and mitigate risks of new components; manage prequalification testing including fit-for-use, piloting work, or other characterization studies to assess component suitability

• Lead process improvement efforts that involve primary packaging and device components as well as SUT (as applicable)

• Work internally and externally to develop best practices and standards for the industry

Education:

• Bachelor's Degree

Required Experience and Skills:

• Minimum 5 years in pharmaceutical manufacturing or technical support roles related to GMP manufacturing of Large Molecule and Sterile Small Molecule products

• Strong functional expertise in primary packaging and device components as demonstrated through technical leadership of component selection, sourcing, and implementation projects

• Technical problem-solving abilities

• Exceptional customer-focused mindset and willingness to support both domestic and international our Manufacturing Division sites

• Strong communications, planning, and collaboration/negotiation skills

• Must be able to operate independently with limited on-site supervision as well as in grey (or undefined) spaces of the organization

• Demonstrated critical thinking skills to develop right-sized solutions for component related projects and activities

• Technical writing proficiency

• Ability to travel to our Company manufacturing and supplier sites in North America and Europe; potential for travel to Latin America and/or Asia for up to 10% of the time

Preferred Experience and Skills:

• Experience in sterile products manufacturing

• Experience in packaging and device component manufacturing

• Experience in Single-Use Technology (SUT) support and manufacturing

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.

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

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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, 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 Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Job Posting End Date:

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Requisition ID:R320899