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Manufacturing Process Specialist

2 months ago

Durham, North Carolina, United States Lilly Full time

Position Overview:

We are seeking dedicated individuals who are committed to enhancing the quality of life for people globally.

Company Overview:

  • At Lilly, we merge compassion with innovation to improve lives worldwide. As a leading global healthcare organization based in Indianapolis, Indiana, our 35,000 employees strive to discover and deliver transformative medicines to those in need, enhance disease understanding and management, and contribute to our communities through philanthropy and volunteer efforts. We prioritize our work and value people above all.
  • Our mission is profound. For over 140 years, we have been at the forefront of developing medicines that enhance lives. These advancements originate in Lilly Research Laboratories, where our scientists endeavor to create new therapies that address the most pressing health challenges of our time. We investigate how cutting-edge therapeutics, innovative technologies, and data analytics can elevate patient health and the healthcare system. Our team is passionate about challenging the status quo and fostering an environment that encourages creative, breakthrough ideas.
  • Recently, Lilly has embarked on an exciting initiative to construct a state-of-the-art facility in Raleigh-Durham, North Carolina, which will manufacture, assemble, and package parenteral drug products.

Benefits Overview:

  • Comprehensive medical, dental, vision, and prescription benefits effective from the first day of employment.
  • Generous paid vacation starting at 120 hours annually (prorated based on start date).
  • Sign-on bonus of $3,000.

Key Responsibilities:

  • During the project phase, the Technician will assist in commissioning and qualification activities necessary for operational readiness of formulation suites, including potential domestic and international travel based on project requirements.
  • Post-project phase, this role will involve executing daily operational tasks as directed by the shift lead or supervisor.

Essential Objectives:

  • Comply with RTP Plant safety protocols and contribute to a secure working environment.
  • Follow standard operating procedures and current Good Manufacturing Practices to ensure product quality.
  • Document process steps accurately on relevant batch documentation (Electronic Ticket, SAP, Cleanings, etc.).
  • Achieve and maintain qualifications for operating assigned process equipment and responsibilities in the area.
  • Identify and propose opportunities for operational enhancements.
  • Proactively oversee documentation and product quality, ensuring all activities are properly recorded and issues reported to supervision.
  • Support the achievement of departmental goals, including enhancing safety performance, minimizing deviations, boosting productivity, and ensuring training compliance.
  • Willingness to work 12-hour shifts.
  • Flexibility is essential as the operations are in the startup phase, and non-routine tasks may be required while prioritizing safety and integrity.
  • Provide support for commissioning, qualification, and operational readiness during the project phase.
  • Assist Site Leadership in establishing a diverse and capable site organization by developing operational procedures and quality controls for the Parenteral Formulation area.
  • Help verify execution documentation (PMX, SAP, Cleaning Logs, etc.).
  • Drive key departmental objectives, including improving safety performance, reducing deviations, enhancing productivity, and ensuring training compliance.

Basic Qualifications:

  • High School Diploma or equivalent.
  • Effective communication skills (both written and verbal).
  • Flexibility and problem-solving capabilities.
  • Basic digital literacy (desktop software).
  • Must pass a fitness for duty physical examination.
  • Ability to work 12-hour shifts with potential for additional overtime as needed.
  • Candidates must be legally authorized to work in the United States.

Preferred Skills:

  • Familiarity with current Good Manufacturing Practices (CGMPs).
  • Experience in operations within the pharmaceutical industry.
  • Experience in compounding/formulation in a Grade C environment.
  • Experience with solution filling equipment and/or isolator technology.
  • Knowledge of lean manufacturing principles.
  • BioWork Certification.

Additional Information:

  • Ability to wear required safety equipment (safety glasses, safety shoes, protective gloves, etc.).
  • This position allows for a flexible working environment during the project phase, including limited remote work with manager approval.
  • Ability to gown and work in controlled classified areas (Grade C and Grade D).

Lilly is an EEO/Affirmative Action Employer and does not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) provide robust support networks for members and assist in developing talented individuals for future leadership roles. Current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, and Working and Living with Disabilities.

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