Sr. Spclst, Engineering

Job Description

Our Elkton facility in Virginia is seeking a highly motivated Technical Operations Senior Process Engineer to join the Vaccine Manufacturing Support Technical Operations team. Located in the scenic Shenandoah Valley, near the University of Virginia and James Madison University, our facility is dedicated to excellence in manufacturing.

The successful candidate will apply their technical skills within a multidisciplinary team to support and enhance our operations. This role requires effective management of multiple projects, strong communication, technical writing, and collaboration skills, as well as robust problem-solving capabilities and a hands-on approach to troubleshooting.

The candidate will provide essential support and direction while demonstrating leadership and teamwork. This role also offers the opportunity to manage a sub-group within the Technical Operations team.

Join us and make a meaningful impact in our operations!

Responsibilities may include:

• Achieving safety, quality, and environmental compliance excellence in all assignments

• Rigorous adherence to tier and IPT standard work

• Providing technical leadership and support, including data analysis, troubleshooting, problem solving, coaching/teaching, and report writing

• Collaborating with cross-functional teams across levels, including leading teams or groups

• Initiating, supporting, or leading change control implementation

• Learning new processes and procedures

• Leading and conducting technical investigations and analyses to determine the root cause of problems

• Recommending and implementing corrective and preventative actions

• Executing continuous improvement projects

• Recommending, creating, writing, reviewing, and approving procedures, instructions, protocols, and other GMP documentation

• Coaching and teaching others

• Contributing to or leading safety reviews and improvements

• Required to be available for off-hours / extended hours work to include (but not limited to) execution of specific activities (batch troubleshooting, validation, process simulation, project execution), escalation and decision making of critical topics (safety, environment, asset, batch quality), regulatory inspections, and event level circumstances,

• Provide support, including leadership support, during inspections

Minimum Education Requirement and Experience:

• Bachelor of Science (B.S.) degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline and a minimum of five (5) years of relevant industrial experience OR

• Master of Science (M.S.) degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline and a minimum of three (3) years of relevant industrial experience OR

• PhD in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline with no experience required.

Required Experience and Skills:

• Experience working in a pharmaceutical or cGMP environment

• Technical writing and presentation experience

• Strong leadership skills

• Strong personal character, ethics, and integrity

• Strong verbal and written communication skills; interpersonal and team skills; and collaborative skills

• Excellent organizational skills

• Robust problem-solving skills and a hands-on approach to troubleshooting and investigation, with a bias towards going to see problems for oneself in the field.

• Strong desire to succeed and to help others to do the same.

• The ability to examine an issue from diverse perspectives (e.g. safety, compliance, maintenance, automation, equipment, process, and people) in order to best understand and resolve it.

• Enthusiasm, confidence, and initiative-taking ability needed for continuous learning and application of knowledge.

• Ability to manage projects and assignments, working towards deadlines within a schedule.

Preferred Experience and Skills:

• Experience managing, coaching, and developing others

• Experience with SAP and DeltaV

• Technical writing experience

• Project management

• In depth technical troubleshooting

• Participa