Lead Process Technician - Device Assembly

Eli Lilly and Company; Durham (NC); On-site; USD 50,000 - 90,000; Full time

Job summary

An established industry player is seeking an Operations Line Leader to join their Device Assembly team. This role is crucial for the safe operation of automated equipment, ensuring the highest quality products for patients. The ideal candidate will possess strong leadership skills, a solid understanding of FDA guidelines, and a knack for problem-solving. You will be responsible for leading operations, developing team members, and driving improvements in safety and productivity. Join a company dedicated to making a difference in healthcare and be part of a team that values innovation and collaboration.

Qualifications

• Demonstrated leadership and persuasion skills required.
• Solid understanding of FDA guidelines and CGMP standards.
• Previous experience in operations in a pharmaceutical setting.

Responsibilities

• Ensure safe operation of automated equipment in Device Assembly.
• Lead manufacturing floor operations ensuring safety and quality.
• Identify opportunities for operational improvements.

Skills

Leadership Skills

Technical Mastery

Communication Skills

Problem-Solving Skills

Flexibility

Education

High School Diploma or GED

Tools

Manufacturing Execution Systems

Electronic Batch Release

Desktop Software

Job description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Description:

The Operations Line Leader will be a key part of the Device Assembly team at RTP, where autoinjector devices are assembled. Line Leader will be responsible for the safe operation of highly automated equipment producing products of the highest quality serving Lilly patients worldwide. In addition, Line Leader will also be responsible for leadership, daily operations, development of operators, building technical autonomy, ensuring compliance with all policies, procedures, and ensuring resources are scheduled accordingly per the daily production plan.

Responsibilities:

• Adhere to RTP Plant safety policies and procedures, contribute to a safe work environment.
• Setup and operate highly automated equipment in the Device Assembly area.
• Provide leadership on manufacturing floor ensuring high level of safety, quality, and productivity to maintain reliable supply of products to patients.
• Technical leader: Key resource for troubleshooting and functions as the primary point of contact for issue escalation on the shop floor.
• Responsible for administering technical training and ensuring all operators are trained to perform tasks.
• Identify opportunities for operational improvements.
• Proactively monitor documentation and product quality, properly documenting all activities and reporting issues to supervision.
• Assist Supervisor in development and performance evaluations of shift operators.
• Key liaison between operations and support functions.
• Lead by example of Safety first & Quality always.
• Operate the equipment and lead the shift operations as required to meet production schedule.
• Assists in checking execution documentation (PMX, SAP, Cleaning Logs, etc.).
• Drives key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance.
• Acts as back-up in Shift Supervisor absence.

Basic Requirements:

• Demonstrated leadership & persuasion skills.
• Affinity for mastering technical concepts.
• Solid understanding of FDA guidelines and CGMP standards.
• Ability to effectively communicate (written and verbal).
• Flexibility and problem-solving skills.
• Basic computer skills (desktop software) are required.
• Previous experience in operations or directly supporting a pharmaceutical manufacturing operation.
• Must Pass a “fitness for duty” physical exam.
• Ability to work 12-hour days on rotating shift.
• Ability to work overtime as required.
• Ability to travel up to 20% during Asset Delivery and < 5% after startup.
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Additional Skills/Preferences:

• High School Diploma or GED required.
• Previous Line Lead experience preferred.
• Previous experience with highly automated equipment.
• Previous experience with Manufacturing Execution Systems and electronic batch release.

Additional Information:

• The position is for the Lilly Research Triangle Park site.
• Position may require a short duration intermittent assignment of 1-2 months (domestic/ International) to establish specific device knowledge, understand equipment, and establish global contacts.
• Ability to wear safety equipment (safety glasses, safety shoes, protective gloves etc.).
• As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company. If you would like to request an accommodation for medical or religious reasons, you may do so at [e-mail].

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.