Senior Consultant Senior Consultant

Körber Group

9d

About The Position

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 be responsible for the commissioning, Qualification, and Validation Services: Lead in the planning, troubleshooting, and execution of the commissioning, qualification, and validation of a wide range of equipment and systems common to the pharmaceutical manufacturing industry. This includes systems, equipment, facilities/utilities, cleaning, laboratories and processes
You will lead and manage a wide range of project engineering activities including equipment research, coordination with third party OEM’s, compilation of technical reports, capital equipment cost analysis, and line design tasks
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 lead and manage quality assurance and regulatory/GMP compliance projects
You will lead and manage project for remediating quality and compliance issues
Auditing Services: CFR 21 Part 11 assessments through mock FDA Inspections
Visual inspection: Specialized services including requirements development through OEE improvement as well as process development, SOP development and technical training for manual, semi-automatic and automated visual inspection
You will develop documents and execute IQ/OQ/PQ on client’s equipment
You will develop documents preventative maintenance, validation standards, and SOP’s
You will assist with a wide variety of internal projects, as needed and instructed by the Head of Department
You will assist with business development activities in collaboration with the Business Development Manager. Tasks include participation in trade shows, professional conferences, tech talks, webinars, etc.
You will assist in the mentoring and training of junior team members as requested by head of department

Requirements

• You have a Bachelor’s degree in a technical, scientific and/or engineering related field
• You have a minimum of 10 years related industry experience
• You are proficient and 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 extensive 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 are familiar 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. Some international travel is also required.

Responsibilities

• Lead in the planning, troubleshooting, and execution of the commissioning, qualification, and validation of a wide range of equipment and systems common to the pharmaceutical manufacturing industry. This includes systems, equipment, facilities/utilities, cleaning, laboratories and processes
• Lead and manage a wide range of project engineering activities including equipment research, coordination with third party OEM’s, compilation of technical reports, capital equipment cost analysis, and line design tasks
• Ensure that tasks, risks, people, resources and budgets are managed effectively
• Oversee and manage OEE improvement campaigns on existing packaging lines
• Lead and manage quality assurance and regulatory/GMP compliance projects
• Lead and manage project for remediating quality and compliance issues
• Auditing Services: CFR 21 Part 11 assessments through mock FDA Inspections
• Visual inspection: Specialized services including requirements development through OEE improvement as well as process development, SOP development and technical training for manual, semi-automatic and automated visual inspection
• Develop documents and execute IQ/OQ/PQ on client’s equipment
• Develop documents preventative maintenance, validation standards, and SOP’s
• Assist with a wide variety of internal projects, as needed and instructed by the Head of Department
• Assist with business development activities in collaboration with the Business Development Manager. Tasks include participation in trade shows, professional conferences, tech talks, webinars, etc.
• Assist in the mentoring and training of junior team members as requested by head of department

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 on customer requirements
• You will get an attractive compensation package including health, dental, vision insurance and retirement plan

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level