Consulting Engineer
Apex, NC, US
Consulting Engineer
Körber is the home for passionate people who innovate, collaborate and love what they do. Entrepreneurial spirit is our joint DNA. We develop future technologies and support talents to deploy their skills and reach their full potential. We combine our strong heritage with our understanding for local specifics and a global mindset to bring people together and create valuable solutions for our customers. We aim for being the first to do the right thing at the right time.
Join the home for entrepreneurs!
Your role in our team
- You will perform Visual Inspections and act as the Packaging Subject Matter Expert to manage all lifecycle services available to our clients.
- You will take charge of the planning, troubleshooting, and execution of the commissioning and validation activities. This includes systems, equipment, facilities/utilities, cleaning, laboratories and processes.
- You will ensure that tasks, risks, people, resources and budgets are managed effectively.
- You will oversee and manage OEE improvement campaigns on existing packaging lines.
- You will manage the quality assurance and regulatory/GMP compliance projects.
- You will manage and assist with remediating quality and compliance issues.
- You will conduct CFR 21 Part 11 assessments through mock FDA Inspections.
- You will carryout specialized services including requirements development through OEE improvement as well as vision tuning, SOP development and technical training for manual, semi-automatic and automated visual inspection.
- You will conduct on-site calibrations, program management and direct maintenance of pharmaceutical manufacturing equipment, to ensure all process-critical, critical, and non-critical instruments are evaluated and calibrated.
- You will take part in commissioning equipment from final assembly, machine start-up through initial FMEA.
- You will develop documents and execute IQ/OQ/PQ on clients equipment.
- You will set standards and documentation for preventative maintenance SOP’s.
- You will take part in preparing and executing validation documents.
Your profile
- You have a Bachelor’s degree in a scientific and/or engineering related field along with 3 – 5 years related industry experience.
- You are able to travel up to 60%.
- You have extensive experience with life sciences manufacturing processes, including aseptic processing, manual & automatic inspection, packaging, and logistics.
- You have excellent verbal communication and technical writing skills.
- You have experience in executing protocols including systems such as Process Validation, computer-controlled systems validation, utilities, manufacturing equipment (isolators, fill/finish, inspection machines, primary packaging, secondary packaging, and end of line packaging)
- You have familiarity with many aspects of validation.
- You are proficient in Microsoft Word, Excel, Power Point and Project.
- You are willing to travel regionally and/or nationally throughout the US.
Your working environment at Körber
Join Körber Pharma and you will work in an innovative, friendly and digital environment providing the opportunity to advance your career. Irrespective of whether it is engineering, production or supporting exciting projects – you have the chance to contribute your expertise and make a difference. As part of the team, you contribute to the solution throughout the entire pharma value chain.
Your benefits
- You will work in a modern work environment with open culture towards improvements and new ideas.
- You are part of a global operating company with a wide customer basis and a growing business.
- You profit from international cooperation within group-expert network to implement corporate wide concepts.
- You will work in a team who is focusing or exceeding customer requirements.
- You will receive an attractive compensation package including health, dental, vision insurance and retirement plan.
Can you find yourself in this profile?
Then you are right at Körber. We are looking forward to getting to know you!
Equal employer opportunity
Körber Pharma is an Equal Employment Opportunity Employer.
Our nation’s military veterans represent the top talent this country has to offer. They bring meaningful skills to the workplace and are assets to our company. We encourage U.S. Military Veterans to apply.
Qualified Applicants must be legally authorized for employment in the United States. Qualified Applicants will not require employer-sponsored work authorization now or in the future for employment in the United States.
Recruitment Team
For questions please contact us via jobs@koerber.com. We work with selected partners and therefore ask recruitment consultancies to refrain from contacting us by mail or telephone.
Please apply exclusively via the “Apply now” button.
Recruiter: Nichole Schally
We value diversity and therefore welcome all applicants - regardless of gender, nationality, ethnic or social origin, religion/belief, disability, age, sexual orientation and identity, and any other protected status.
Recruitment-Team
For questions please contact us via jobs@koerber.com.
Please apply exclusively via the “Apply now” button.
Körber Pharma is a Business Area of Körber, an international technology group with around 12,000 employees and more than 100 locations worldwide. At Business Area Pharma we offer a unique portfolio of integrated solutions that deliver the difference along the pharma value chain. Spanning our in-depth expertise in consulting, inspection, handling, packaging machines and materials, Körber has always the right solutions to unlock the potential of our customer’s productivity. With proven understanding of pharma process and regulation challenges, Körber is the partner to make the most out of pharma and biotech production for customers.
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