Lead Safety Engineer

2 weeks ago

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

At BioSpace, Inc., we are dedicated to improving lives through innovative healthcare solutions. As a prominent player in the global healthcare landscape, we focus on discovering and delivering transformative therapies to patients worldwide. Our commitment to excellence is reflected in our workforce, which is driven by a passion for making a positive impact.

Lead Safety Engineer - Advanced Therapies Manufacturing

We are excited to announce an opportunity for a Lead Safety Engineer to join our Advanced Therapies Manufacturing team. This role is pivotal in establishing a state-of-the-art facility dedicated to the production of groundbreaking therapies. The successful candidate will play a crucial role in the startup of this facility, which is designed to incorporate cutting-edge manufacturing technologies and advanced data analytics to enhance safety, quality, and operational efficiency.

Key Responsibilities:

Pre-Startup and Startup Phase:
  • Provide dynamic and inclusive leadership to foster a collaborative environment across the Health, Safety, and Environmental (HSE) team and other departments during the operational readiness and startup phases.
  • Work closely with senior management to define and prioritize the capabilities and resources necessary to cultivate a robust HSE culture that aligns with industry standards.
  • Act as a key stakeholder in the project team, offering insights and recommendations on HSE-related design choices and startup strategies to ensure compliance and project objectives are met.
  • Establish strong technical relationships with corporate and global teams to support strategic initiatives at the facility level.
  • Assist in the development and implementation of HSE programs tailored for the Advanced Therapies facility, contributing to a positive and proactive safety culture.
  • Lead the execution of specific HSE programs, including but not limited to lockout/tagout procedures, personal protective equipment (PPE) protocols, and hazard communication strategies.
  • Collaborate with the project team to ensure that health and safety considerations are integrated into all aspects of facility design and construction.
  • Design and implement comprehensive safety and health programs, including training and onboarding for new employees to promote a strong HSE culture.
  • Build partnerships with Operations, Maintenance, and Engineering teams to manage changes effectively and ensure compliance with safety standards.
Post Startup Responsibilities:
  • Serve as the primary contact for HSE programs, maintaining expertise in applicable regulations and ensuring compliance with corporate and local requirements.
  • Coordinate and oversee internal and external reporting related to HSE initiatives, ensuring timely and accurate submissions.
  • Support operational teams in understanding and implementing regulatory requirements, facilitating compliance solutions.
  • Conduct internal HSE audits and assessments, lead incident investigations, and analyze HSE data to drive continuous improvement.
  • Act as a liaison between the facility, regulatory bodies, and contractors to address program needs effectively.
  • Lead the site emergency response team, providing guidance during emergencies and ensuring preparedness for various scenarios.
  • Participate in safety inspections and provide coaching on safety practices and mitigation strategies.
  • Maintain comprehensive safety records in accordance with regulatory requirements.
  • Engage in hazard reviews to ensure compliance with safety programs and documentation standards.
Additional Responsibilities:
  • Focus on safe manufacturing operations, including chemical handling, equipment isolation, and fire prevention measures.
  • Oversee environmental compliance and manage activities related to environmental permits.
  • Collaborate with key stakeholders to enhance the effectiveness of HSE services across the organization.
  • Participate in governance meetings to drive safety initiatives and programs.
  • Provide leadership and ownership of HSE programs to ensure adherence to regulations and corporate standards.
  • Act as a representative of the company in interactions with regulatory and third-party officials.
  • Be available for off-hour support for emergency response and production needs as required.
Qualifications:
  • Bachelor's degree in engineering or a related scientific discipline.
  • A minimum of 5 years of experience in manufacturing operations, preferably within the pharmaceutical or chemical sectors.
  • Proven experience in applying health and safety regulations and developing HSE programs.
Preferred Skills:
  • Strong organizational and time management abilities, coupled with analytical skills.
  • Excellent collaboration and communication skills.
  • Proven leadership capabilities in cross-functional and technical teams.
  • Experience working with HSE regulatory agencies.

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