Process Improvement Specialist II

2 weeks ago

Clayton, North Carolina, United States BioSpace, Inc. Full time
Job Overview

Department Overview

Become an integral part of the Fill & Finish Expansions (FFEx) team, which is focused on significant expansion initiatives in sterile production, solid dosage forms, finished products, warehousing, and quality control.

This division is crucial to the global operations of BioSpace, Inc.

FFEx represents a forward-thinking area dedicated to the design and construction of new aseptic filling capabilities to meet the healthcare demands of numerous patients.

Our goal is to transform our production facilities by integrating state-of-the-art technology, establishing a standard for future sterile production. Working within FF Expansions involves engaging with diverse teams and cultures on a global scale.

What We Provide:
  • Competitive compensation and annual performance bonuses for all positions
  • Generous paid time off, including 14 paid holidays
  • Immediate coverage for Health, Dental, and Vision Insurance
  • 8% 401K contribution with matching options
  • Family-friendly benefits, including paid parental and family medical leave
  • Access to BioSpace's pharmaceutical products
  • Tuition reimbursement, life & disability insurance, employee referral bonuses
At BioSpace, Inc., we offer a wealth of opportunities, resources, and mentorship to help you advance your career.

Position Responsibilities

As a vital member of the team, you will enhance operations by coordinating personnel, equipment, and processes to fulfill business and regulatory requirements.

In this position, you will provide training, showcase expertise, propose process solutions, and contribute to ongoing improvement initiatives. You will also serve as a mentor to junior team members as necessary.

Collaboration

You will work closely with stakeholders and team members, offering support and training as needed.

Key Responsibilities
  • Conduct comprehensive deviation investigations and root cause analyses
  • Propel continuous improvements utilizing Lean and Six Sigma methodologies
  • Maintain in-depth process knowledge and expertise in designated areas
  • Identify and implement process enhancements for complex challenges
  • Engage in periodic reviews and reporting, collaborating across multiple locations
  • Manage area master data and recipes, provide support, and adhere to safety & environmental protocols
  • Perform additional duties as assigned
Physical Requirements
  • Comfort in an open office environment with occasional distractions
  • Ability to travel up to 20% of the time (specific percentage may vary based on role)
Qualifications
  • Bachelor's degree in engineering or a related field preferred, or equivalent experience
  • Experience in manufacturing, particularly within pharmaceutical settings, is highly regarded
  • Strong written communication, problem-solving, and LEAN manufacturing skills
  • Knowledge of change control systems, Quality Management Systems (QMS), and electronic manufacturing systems
  • Familiarity with adult learning methodologies and regulatory audits is essential
  • Experience in validation and product transfer is considered a plus
We are committed to promoting diversity and equal opportunities in our recruitment processes.

BioSpace, Inc. aims not only to be the best company but the best company for the world. Our success lies in our talented employees with varied perspectives, backgrounds, and cultures. We are dedicated to fostering an inclusive environment that celebrates our diversity, transforming lives together.

BioSpace, Inc. is an equal opportunity employer. We welcome applications from individuals regardless of race, ethnicity, gender, sexual orientation, disability, or veteran status.

If you require special assistance or accommodations during the application process, please reach out to us.

This contact is solely for accommodation requests and not for application status inquiries.

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