Sr. Principal Engineer - Bioprocess

BioSpace; Richmond (VA); On-site; USD 80,000 - 172,000; Full time

Benefits offered by this job

401(k) participation

Pension plan

Vacation benefits

Medical/dental/vision benefits

Flexible spending accounts

Life insurance

Leave of absence benefits

Well-being benefits

Job summary

Lilly is building a new manufacturing facility in Goochland County, Virginia for monoclonal antibodies, bioconjugates, and aseptic drug product manufacturing. A Sr.

Principal Bioprocess Engineer will help build the organization, the facility, and the culture to enable startup and ongoing GMP operations. The role covers startup and post-startup activities, including process safety, C&Q support, transfer, training, and continuous improvement, while ensuring right-first-time results and adherence

Qualifications

• Bachelor's Degree in Process, Chemical, Biochemical Engineering or related applicable discipline.
• 7+ years of process team experience in pharmaceutical manufacturing.
• Authorized to work in the United States on a full-time basis; Lilly will not sponsor work authorization.

Responsibilities

• Support the New Manufacturing Facility startup in Goochland County, VA.
• Provide Process Engineering support to Global Facility Delivery team with focus on right first time startup.
• Define and own the Operational Readiness Plan details (SOPs, maintenance, automation, MES, alarms).
• Own the Qualification strategy and execution for the area of responsibility.
• Support initial Operations Training as Equipment and Area SME.
• Lead or support tech transfer of new processes into the facility.
• Identify continuous improvement opportunities in equipment and processes.
• Use root-cause analysis to investigate issues and implement corrective actions.

Skills

Process engineering

Pharmaceutical manufacturing

Education

Bachelor's degree in Process/ Chemical/ Biochemical Engineering

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Lilly is currently constructing an advanced manufacturing facility for monoclonal antibodies, bioconjugates, and aseptic drug product manufacturing in Goochland County, Virginia. This facility is intended to provide capacity for current and future products. The successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.

Responsibilities

We are seeking a Sr. Principal Bioprocess Engineer to support our new Manufacturing Facility in Goochland County, Virginia. Process Engineering is core to delivering a right first-time facility start up and continued support of ongoing manufacturing operations into the future.

Some key responsibilities of the role include:

• Facility Start-Up Phase;
• Provide Process Engineering support to the Global Facility Delivery team (Lilly’s Global Large Scale Capital Delivery Team) with a strong focus on right first time and on schedule facility start-up (e.g. design reviews, process safety assessments, User Requirements, C&Q support, Unit Operation Shakedown, Facility Run Rate Readiness)
• Define and own relevant aspects of the overall integrated Operational Readiness Plan (e.g. SOP development, maintenance strategy, automation optimization, run rate readiness, MES EBR requirements, alarm requirements, Performance Qualification Study Requirements / Protocol Development etc.)
• Own the Performance Qualification strategy and execution for area of responsibility
• Support initial Operations Training requirements as the Equipment and Area SME
• Lead/support the tech transfer of new processes into the facility
• Post facility start-up phase;
• Provide process engineering support through application of process engineering fundamentals
• Identify and implement continuous improvement opportunities related to equipment and processes as core member of cross-functional process team.
• Utilise root cause analysis techniques to investigate process and equipment issues and deliver robust and sustainable corrective and preventative actions
• Monitor, assess and document equipment performance to maintain ongoing qualification.
• Develop and maintain the basis of safety for process equipment
• Develop and implement unit operation and equipment control strategy

Basic Qualifications

• Bachelor's Degree in Process, Chemical, Biochemical Engineering or related applicable discipline
• 7+ years of process team experience in pharmaceutical manufacturing, preferably monoclonal antibody manufacturing
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

Additional Preferences

• Deep technical interest and understanding in the field of monoclonal antibody manufacturing and Bioprocess Engineering.
• Strong analytical and problem-solving skills.
• Ability to work on own initiative and as part of a Process Team consisting of a diverse group of management, production, science, quality and engineering professionals.
• Creativity to identify improvement opportunities and the tenacity/initiative to see them implemented.
• Guidance/mentoring of others through processes.
• Flexibility to meet business needs.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$79,500 - $171,600

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

• including eligibility to participate in a company-sponsored 401(k)
• pension
• vacation benefits
• eligibility for medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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