Senior Specialist - Engineering

Job Description

Due to continued growth and investment, our Company is hiring a Senior Specialist, Process Engineering within Global Engineering Solutions (GES) supporting our Company's Capital Project Portfolio.  The Senior Specialist, based at our Elkton, Virginia site, will support the portfolio of capital projects and initiatives for the Small Molecule Line of Business.  The initial assignment for this role will be to support the design and delivery of the Small Molecule Center of Excellence in Elkton, Virginia. This specific role is for support of the Drug Product (DP) scope of the capital project, which includes both Oral Solid Dosage (OSD) and Spray Dried Intermediates (SDI).

The Senior Specialist will participate on a high performing team responsible for capital project scope and technical studies that support our company’s business objectives. Under the direction of a Process Lead or Technology Director, the Senior Specialist will be responsible for planning, design, and implementation of capital projects including scope generation, process and facility design, equipment selection, vendor interaction, factory acceptance testing, construction support, equipment qualification, facility start-up, technology transfer, and process demonstrations. The individual collaborates with Integrated Project Team (IPT) members (e.g. Operations, Project Management, Technology, Maintenance, Automation and Safety), Engineering Firms and Vendors to progress deliverables.

The Senior Specialist shall exhibit strong leadership, interpersonal, collaboration and communication skills for both decision making and guiding team members.  The candidate should have a strong understanding of the line of business, understand lean design and delivery, have the ability to implement standard work, and be able to lead technical areas and capital projects from an end to end perspective.

The Senior Specialist will initially provide primary support to the Small Molecule Human Health line of business, and is expected to develop and maintain technical knowledge in their respective area(s) of expertise.  With a large volume and variety of capital project work in GES, this position will also afford future opportunities to be exposed to multiple business areas.  This may include Large Molecule Biologics/Vaccines/Sterile both for Human Health and Animal Health, with a focus on potential future potent products and associated facilities and containment technologies.

Key Responsibilities

• Interface with our company's IPT members in support of capital project delivery, providing solutions that meet business objectives.

• Ability to assess multiple options and select a leading approach.

• Core knowledge should include specification of unit operations, P&ID development, Hazard Analysis, electrical classified design, equipment design and operation, commissioning & qualification.

• Familiarity with active pharmaceutical ingredient and oral solid dose unit operations, chemical handling, process safety, and containment approaches in terms of solution development.

• Operating within cost and schedule constraints of the project and department

• Lead and collaborate with contractors, suppliers and other team members in the execution of the work, ensuring adherence to the GES Project Roadmap for capital project execution

• Drive design of process equipment as a Package Owner or Suite Lead, including collaboration with Engineering Firms and Equipment Suppliers

• Lead Factory Acceptance Testing, and Commissioning and Qualification activities

• Lead peer reviews for assigned Packages and active participation in peer reviews across multiple projects.

• Maintain knowledge of best practices and industry trends; may participate in professional/technical organizations.

• Participate in the development and review of core documents such as procedures, practices, engineering guidelines, standards, etc.

Experience

• Minimum 5 years Pharmaceutical/Biotech industry in engineering, technology, and/or manufacturing role

• Understanding of standard unit operations for OSD/SDI manufacturing, with unit operation design, startup, and/or operation preferred

• Experience with equipment life cycle approach and Capital Management stage gate process

Skills

• Creative, innovative, thinks outside of the box, self-motivated, applies problem-solving skills, and solid base in engineering fundamentals and equipment troubleshooting

• Demonstrated leadership and teamwork skills.  Ability to get results in a cross functional environment and ability to effectively collaborate with and influence partners.

• Effective written and verbal communication skills

• Project/Time Management skills which deliver on-time and quality work

Qualifications:

• Bachelor's degree (or higher) in Engineering or applicable Science

Percent of travel

Up to 50% for projects assignments outside of primary location. Travel and flexibility in project assignment location is required; assignments may require short term travel assignments. For the initial assignment, travel will be expected to support the design efforts and may include both domestic and international travel.

Why is this a compelling position for a dynamic and ambitious Process Engineering professional to consider?

• Excellent opportunity to play a key role in the future development of our Company’s Small Molecule supply network. Our Company is undergoing a period of significant investment in US based small molecule manufacturing, presenting wide ranging opportunity to demonstrate technical acumen, leadership and innovation in delivering the capital portfolio.

• Superb opportunity to join the existing GES team in Virginia and become a part of the broader GES community of our Company, which presents opportunities to be exposed to the network of sites across our Company's worldwide while developing and growing your career.

• Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and the people that matter the most in their lives.

Required Skills:

Adaptability, Engineering Standards, Good Manufacturing Practices (GMP), Process Optimization, Regulatory Compliance, Strategic Thinking, Teamwork

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

$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:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

50%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

03/30/2026

*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.