Senior Operations Engineer - API

Description

The company is a research-intensive biopharmaceutical business that uses science to prevent and treat disease in people and animals.

The new Elkton, Virginia site is a purpose-built, agile small molecule plant that will supply medicines to US patients. It is designed to move quickly and reliably, taking technology transfers from commercial sites and fast-following them into production with a focus on quality, safety, and operational excellence.

The team is building small molecule expertise in the US and wants people who want to grow their skills, improve how the site runs, and help it expand.

In this role you support the API Integrated Product Team (IPT) through commissioning, qualification, start-up, and operational readiness, working with cross-functional groups to keep operations safe, compliant, and efficient during project work and routine manufacturing. You also coordinate and prioritize improvement work across the IPT as the site moves into routine operations.

Responsibilities

• Help bring the new API small molecule plant in Elkton, VA through commissioning, qualification, start-up, and operational readiness.
• Work with Operations, Engineering, Quality, Technical Operations, Supply Chain, and other stakeholders to keep start-up safe, compliant, and effective.
• Give technical and operational support during equipment and process start-up, troubleshooting, and optimization.
• Support technology transfer and the introduction of commercial manufacturing processes at the new site.
• Help define, put in place, and refine operating practices, standard work, procedures, and routines that keep operations reliable and compliant.
• Coordinate and rank improvement activities and focus areas across the IPT to match business goals and performance targets.
• Apply the company's Production System (MPS) tools and lean methods, such as Kaizen, 5S, visual management, and Standard Work, to find and act on improvement opportunities.
• Spread good practices across shifts, functions, and workstreams to improve consistency, efficiency, and execution.
• Reinforce safety, quality, compliance, accountability, and continuous improvement.
• Cover for the Production Lead when needed to keep leadership and cross-functional coordination steady.
• Help build an inclusive, collaborative, and performance-driven team.

Requirements

• Bachelor's degree required.
• Preferred: degree in Chemical Engineering, Pharmaceutical Engineering, Biochemical Engineering, Chemistry, or a related technical discipline.
• At least 5 years in API small molecule manufacturing, in operations or technical operations.
• Experience in a cross-functional manufacturing, technical, or operations setting.
• Experience with operational improvement, troubleshooting, process support, or start-up work.
• Working knowledge of GMP, quality, and compliance expectations in pharmaceutical manufacturing.
• Strong problem-solving, communication, collaboration, and organization skills.
• Able to work well across Operations, Engineering, Quality, and Technical teams.
• Able to set priorities in a dynamic, fast-moving setting.
• Demonstrated commitment to safety, operational excellence, and continuous improvement.
• Required skills listed include adaptability, analytical problem solving, business process improvement, cGMP compliance, chemical engineering, collaborative leadership, cross-functional project management, data analysis, decision making, employee scheduling, engineering support, focused improvement, inventory management, leadership theories, Lean Six Sigma continuous improvement, manufacturing, manufacturing processes, manufacturing strategies, manufacturing systems, manufacturing technologies, operational quality, operations engineering, personal initiative, process improvements, plus 8 more.
• Preferred: experience supporting commissioning, qualification, start-up, or validation activities.
• Preferred: experience in a greenfield or new facility start-up.
• Preferred: experience with technology transfer and implementation of commercial manufacturing processes.
• Preferred: experience applying lean tools such as Kaizen, 5S, and Standard Work.
• Preferred: experience coordinating work across shifts, teams, or functions.
• Preferred: experience in a lead, coordinator, or delegate role that supports leadership continuity.
• Preferred: experience finding improvement opportunities and putting practical solutions in place in manufacturing.

Conditions

Primary location is Elkton, Virginia, USA.

Regular employee role on the 1st day shift.

Travel requirement is 10%.

Relocation is domestic.

No visa sponsorship.

Flexible work arrangements do not apply.

No hazardous materials involved.

A valid driving license is not required.

Base salary range for the primary location is $96,200.00 - $151,400.00, shown where required by law. Placement within the range depends on education, qualifications, certifications, experience, skills, geographic location, government requirements, and business needs.

Open to US and Puerto Rico residents only.

The company is committed to inclusion and provides accommodation during hiring on request.

The posting is effective until 11:59:59 PM on the day before 11/9/2026, so apply by then.

Benefits

• Medical, dental, and vision coverage, plus other insurance for employees and their families.
• Retirement benefits, including a 401(k).
• Paid holidays, vacation, and compassionate and sick days.
• Eligible for an annual bonus and long-term incentive, where applicable.