Process Technician

RXinsider LTD.; Kinston (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

West Pharmaceutical Services in North Carolina is seeking a Process Engineer to support the Process Engineering Team with modifications, validations, and enhancements of process equipment and tooling to ensure safety, maximum yields, quality, cost effectiveness and throughput of our processes.

You will assist with equipment and process qualifications, review validation documentation, participate in change controls and drive continuous improvement while adhering to cGMP, ISO and CE requirements.

Qualifications

• 2+ years’ experience in manufacturing/regulated industry.
• Basic knowledge of LEAN 6 sigma manufacturing principles.
• Yellow belt of higher an advantage.
• Experience with validation of processes/equipment.
• cGMP experience is an advantage.
• Self-motivated, results-oriented with strong communication and project management.

Responsibilities

• Support process engineering activities and change controls.
• Assist with equipment/process qualifications and validation documents.
• Review validation documentation and safeguard confidential information.
• Participate in continuous improvement projects and process changes.
• Ensure compliance with cGMP, ISO, CE and local regulations.
• Transfer knowledge to Operations and support safety and quality goals.

Skills

LEAN SIX SIGMA

Validation protocols

CAPA

cGMP knowledge

Education

High School Diploma or GED

Job description

Description

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World war 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Job Summary

This role will support the Process Engineering Team with modifications, validations, and enhancements of process equipment, and tooling to new and existing products to ensure safety, maximum yields, quality, cost effectiveness and throughput of our processes.

Essential Duties And Responsibilities

• Support Key Activities within the Process Engineering Dept.
• Assist with the execution of equipment / process qualifications as required.
• Read and understand the execution of validation documentation protocols and summary reports.
• Assist with the implementation of equipment and/or process changes in line with the necessary change control process.
• Participate in the efforts towards continuous improvement on quality, service, HSE and costs, to achieve state-of-the-art manufacturing processes.
• Participate with the modifications, improvements, or validations of existing or new products, processes, tooling, equipment.
• Review processes continually to ensure their quality and efficiency.
• Participate in process improvement projects.
• Work closely with Process Engineering on the introduction of new equipment or technology.
• Assist with ‘trouble shooting’ improvements when required in production.
• Review process engineering documentation and safeguard confidential information.
• Work within formal systems, such as cGMP, ISO, CE to ensure that new processes and improvements conform with quality and legal requirements.
• Support to the Global (Process) Engineering group. Support local projects to implement the Global PE initiatives.
• Ensure that all projects and activities are in compliance with local, regional and best practice requirements on HSE and meet authority requirements.
• Keep Process Engineering manager advised of any unusual situation which might impair or affect safety, quality, production output or assigned projects.
• Transfer of process knowledge to Operations Group as required.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all local site Environmental, Health and Safety regulations.
• Compliance to all local site company policies, procedures and corporate policies.
• Other duties as assigned.

Education

• High School Diploma or GED Required.

Preferred Knowledge, Skills And Abilities

• 2+ years’ experience in a similar position within the manufacturing industry, ideally in a regulated industry.
• Basic knowledge of LEAN 6 sigma manufacturing principles
• Yellow belt of higher an advantage.
• Experience with continuous improvement of processes and validations of processes/equipment
• cGMP experience is an advantage.
• Self-motivated, results-and solution-oriented personality
• Well-developed communication and interpersonal skills.
• Good organizational and project management skills.
• Highly analytical and structured way of working
• Experience with drafting and execution of validation protocols and associated documentation.
• Knowledge of CAPA systems and use of formal problem-solving tools.

Travel Requirements

10%: Up to 26 business days per year

Physical Requirements

Light-Exerting up to 20lbs/9kg of force frequently, and/or negligible amount of force frequently constantly to move objects.

What We Offer

No relocation is provided for this opportunity

Sponsorship is not provided for this opportunity

This is an onsite position requiring the team member to be onsite 5 days per week

Shift

This position is a 12 hour 2-2-3-2 night schedule. 5:45 PM - 6:00 AM.

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening.