Senior Specialist, Engineering

Merck • Elkton, VA

1d • Hybrid

About The Position

Due to continued growth and investment, our company is hiring a Senior Specialist, Process Engineering within Global Engineering Solutions (GES) supporting the 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 Active Pharmaceutical Ingredient (API) scope of the capital project.
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.
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 company GES community which presents opportunities to be exposed to the network of sites across our company 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.

Requirements

• Minimum 5 years Pharmaceutical/Biotech industry in engineering, technology, and/or manufacturing role
• Understanding of standard unit operations for API manufacturing, with unit operation design, startup, and/or operation preferred
• Experience with equipment life cycle approach and Capital Management stage gate process
• 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
• Bachelor's degree (or higher) in Engineering or applicable Science

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.

Benefits

• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level