Packaging Solutions Engineer

2 weeks ago

Apex, North Carolina, United States Körber Group Full time

Körber is a hub for dedicated individuals who thrive on innovation, teamwork, and a passion for their work. Our entrepreneurial spirit is woven into our culture. We are committed to developing cutting-edge technologies and empowering our talents to harness their skills and achieve their fullest potential. By merging our rich legacy with an understanding of local nuances and a global perspective, we unite people to create impactful solutions for our clients. Our goal is to be pioneers in doing the right thing at the right moment.

Become part of our entrepreneurial environment

Your responsibilities within our team

  • You will conduct Visual Inspections and serve as the Packaging Subject Matter Expert, overseeing all lifecycle services available to our clients.
  • You will lead the planning, troubleshooting, and execution of commissioning and validation activities, encompassing systems, equipment, facilities/utilities, cleaning, laboratories, and processes.
  • You will ensure effective management of tasks, risks, personnel, resources, and budgets.
  • You will supervise and drive OEE improvement initiatives on existing packaging lines.
  • You will manage quality assurance and regulatory/GMP compliance projects.
  • You will assist in resolving quality and compliance challenges.
  • You will perform CFR 21 Part 11 assessments through mock FDA Inspections.
  • You will deliver specialized services, including requirements development through OEE enhancement, vision tuning, SOP creation, and technical training for manual, semi-automatic, and automated visual inspection.
  • You will execute on-site calibrations, program management, and direct maintenance of pharmaceutical manufacturing equipment to ensure evaluation and calibration of all process-critical, critical, and non-critical instruments.
  • You will participate in the commissioning of equipment from final assembly to initial FMEA.
  • You will develop documentation and execute IQ/OQ/PQ on client equipment.
  • You will establish standards and documentation for preventative maintenance SOPs.
  • You will contribute to the preparation and execution of validation documents.
Your qualifications
  • You possess a Bachelor's degree in a scientific or engineering discipline, along with 3 - 5 years of relevant industry experience.
  • You are open to traveling up to 60% of the time.
  • You have substantial experience with life sciences manufacturing processes, including aseptic processing, manual & automatic inspection, packaging, and logistics.
  • You exhibit excellent verbal communication and technical writing abilities.
  • You have experience in executing protocols for systems such as Process Validation, computer-controlled systems validation, utilities, and manufacturing equipment (isolators, fill/finish, inspection machines, primary packaging, secondary packaging, and end-of-line packaging).
  • You are familiar with various aspects of validation.
  • You are proficient in Microsoft Word, Excel, PowerPoint, and Project.
  • You are willing to travel regionally and/or nationally.
Your working environment at Körber

Join Körber Pharma and experience an innovative, friendly, and digital workspace that offers opportunities for career advancement. Whether in engineering, production, or supporting exciting projects, you will have the chance to apply your expertise and make a significant impact. As part of our team, you will contribute to solutions throughout the entire pharmaceutical value chain.

Your advantages
  • You will work in a modern environment that fosters an open culture towards improvements and new ideas.
  • You will be part of a globally operating company with a diverse customer base and a growing business.
  • You will benefit from international collaboration within a group-expert network to implement corporate-wide concepts.
  • You will work in a team dedicated to meeting or exceeding customer expectations.
  • You will receive a competitive compensation package that includes health, dental, vision insurance, and a retirement plan.
Are you the right fit for this profile?

We look forward to getting to know you

Equal opportunity employer

Körber Pharma is an Equal Employment Opportunity Employer. We value diversity and encourage all applicants, regardless of gender, nationality, ethnic or social origin, religion/belief, disability, age, sexual orientation, and identity, as well as any other protected status.

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