Manufacturing Execution Systems Specialist

2 weeks ago

Lebanon, Indiana, United States BioSpace, Inc. Full time
Position Overview

At BioSpace, Inc., we are dedicated to advancing healthcare through innovation and excellence. Our team is committed to improving the lives of individuals globally by delivering cutting-edge solutions in the biopharmaceutical industry. We are seeking passionate individuals who are eager to contribute to our mission of enhancing patient outcomes.

Company Insight:

BioSpace, Inc. is at the forefront of the biopharmaceutical sector, striving to develop and provide life-changing therapies. Our workforce is composed of dedicated professionals who collaborate to push the boundaries of science and technology. We prioritize our people and their contributions to our shared goals.

As we embark on a significant growth trajectory, we are excited to announce the establishment of a new state-of-the-art facility focused on advanced manufacturing processes. This facility will incorporate the latest technologies and methodologies to ensure efficient and sustainable production practices. Joining our team presents a unique opportunity to play a pivotal role in shaping the future of our operations.

Key Responsibilities:

As a Manufacturing Execution Systems Specialist, you will be integral to the design, development, and implementation of MES solutions within our facility. Your responsibilities will include:
  • Ensuring operational readiness in alignment with digital execution strategies.
  • Adapting project roadmaps to align with evolving site needs and industry trends.
  • Collaborating with cross-functional teams to establish and execute the IT roadmap.
  • Fostering a culture of excellence based on our core values and operational standards.
  • Executing the MES strategy effectively.
  • Influencing business practices towards standardization and value creation.
  • Translating functional requirements into effective technical solutions.
  • Maintaining comprehensive project documentation throughout the lifecycle.
  • Developing and maintaining MES interfaces with other systems.
  • Ensuring compliance with regulatory and quality standards.
  • Managing the lifecycle of systems to maintain their validated state.
  • Facilitating incident and change management processes in alignment with business needs.
  • Building relationships with global teams and acting as a subject matter expert.
  • Creating training materials to support system users.
  • Utilizing strong analytical and problem-solving skills to address challenges.
  • Communicating effectively across various levels of the organization.
Qualifications:
  • Extensive knowledge and experience with Manufacturing Execution Systems.
  • Familiarity with GMP regulatory requirements and FDA guidelines.
  • Solid understanding of Computer System Validation processes.
  • Proven ability to analyze and resolve complex technical and operational issues.
  • Strong prioritization and escalation skills.
  • Demonstrated learning agility and curiosity.
  • Ability to translate quality control processes into IT requirements.
Educational Background:
  • Bachelor's degree in IT, Engineering, Chemistry, Pharmacy, or a related field.
  • A minimum of 5 years of relevant experience in MES and DCS integration.
  • Experience in a regulated environment is preferred.
Additional Information:
  • This role requires on-site presence and flexibility to support varying production schedules.
  • Travel to other company sites may be necessary as part of the role.
BioSpace, Inc. is an equal opportunity employer and values diversity in our workforce. We encourage individuals from all backgrounds to apply.

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