Lead Manufacturing Engineer

3 weeks ago

Marquand, Missouri, United States BioSpace, Inc. Full time
Position Overview

At BioSpace, Inc., we are dedicated to enhancing lives through innovative healthcare solutions. As a prominent player in the biopharmaceutical industry, we strive to discover and deliver transformative therapies that improve patient outcomes globally.

Our workforce is committed to excellence, and we prioritize the well-being of our communities. We seek individuals who are passionate about making a positive impact in the healthcare landscape.



About BioSpace, Inc.:
BioSpace, Inc. is at the forefront of biopharmaceutical advancements, focusing on the development and commercialization of cutting-edge therapies that address critical health challenges.

We leverage a robust pipeline of innovative products and a highly skilled team to drive our mission forward.



Role Summary:

The Lead Manufacturing Engineer will collaborate with interdisciplinary teams to ensure that manufacturing system designs, processes, and protocols are developed and maintained in accordance with regulatory standards in a Good Manufacturing Practice (GMP) environment.

This engineering position will serve as a Subject Matter Expert on production equipment within a controlled environment, supporting both clinical and commercial operations.

The Lead Manufacturing Engineer will be tasked with reviewing and approving design specifications, evaluating risks associated with equipment and processes, executing project responsibilities, overseeing project implementation, adhering to quality protocols, and supporting manufacturing systems.


Key Responsibilities:
  • Provide engineering guidance from project inception through qualification for new and existing manufacturing systems.
  • Review technical drawings and specifications to assess requirements and feasibility.
  • Conduct necessary scientific and engineering analyses.
  • Develop preliminary design proposals.
  • Engage with production teams to identify and resolve manufacturing/design challenges and implement enhancements.
  • Act as a liaison between Engineering and manufacturing operations for related issues and improvements.
  • Perform risk assessments and devise mitigation strategies.
  • Create acceptance criteria and execute acceptance testing.
  • Draft process validation protocols, execute them, and document outcomes.
  • Manage vendor interactions regarding supplied parts or equipment.
  • Prepare Request for Proposal (RFP) and Request for Quotation (RFQ) documents.
  • Participate in engineering and design reviews as necessary.
  • Generate technical documentation, including qualification test procedures and maintenance manuals.
  • Oversee the integration of technical activities and products.
  • Evaluate and authorize design modifications and specifications.
  • Maintain operational documentation as required.
  • Keep management informed of project status, workload, and progress.
  • Develop project plans, schedules, budgets, and interim reports.
  • Adhere to all regulatory and safety protocols.
  • Foster a customer service-oriented approach when interacting with internal and external stakeholders.
  • Maintain a clean and safe working environment.
  • Apply engineering principles to troubleshoot equipment and system issues.
  • Manage projects and create dashboards for reporting.
  • Effectively communicate complex technical matters to cross-functional teams.
  • Collaborate with teams to conduct tests, perform root cause analyses, and participate in investigations.
  • Comply with all relevant regulations and company policies.

Qualifications:
  • Bachelor's degree in Engineering or a related field is required.
  • A minimum of 8 years of relevant experience is required.
  • Proficiency in Microsoft Office applications is essential.
  • Strong organizational skills and self-motivation, coupled with excellent communication abilities and an analytical mindset.

Preferred Qualifications:
  • Ability to exercise technical judgment in planning and executing engineering tasks.
  • Experience in clean room environments is preferred.
  • Stay updated on technical advancements in the field.
  • Identify and implement best practices for process execution.

Physical Requirements/Travel:
  • Willingness to travel domestically and internationally, approximately 10-20%.
  • Ability to don clean room attire regularly.
  • Prolonged standing (over 6 hours) may be necessary during production oversight.
  • Occasional lifting of up to 40 lbs may be required.

The physical demands outlined are representative of those that must be met by an employee to successfully perform the essential functions of this role.


The work environment for this position is within a manufacturing setting.

BioSpace, Inc. is committed to fostering an inclusive workplace and ensuring equal opportunities for all candidates. We welcome individuals from diverse backgrounds to apply and contribute to our mission of improving global health.

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