Lead Manager, Facilities and Equipment Validation

2 weeks ago

Ayer, Massachusetts, United States BioSpace, Inc. Full time
Position Overview

About Us
At BioSpace, Inc., we believe in the power of innovation and collaboration. Our work is not just about meeting expectations; it’s about exceeding them and making a significant impact in the lives of patients. Here, you will engage in challenging and meaningful projects that contribute to groundbreaking advancements in the biopharmaceutical industry.

As a Lead Manager, you will play a crucial role in the qualification of laboratory, clinical, and commercial manufacturing systems at a multi-product facility. This position involves close collaboration with internal teams, peer-level clients, and external service providers to ensure operational excellence.

The successful candidate will oversee a team of professionals responsible for qualifying new equipment and maintaining systems in a validated state, adhering to established protocols. You will manage multiple projects of varying complexity, ensuring timely and budget-conscious completion while providing guidance and support to your team.

Key Responsibilities:
  • Direct the Facilities, Utilities & Equipment (FUE) and Analytical Instrument Qualification (AIQ) processes for the BioSpace manufacturing site, focusing on compliance and validation for cell therapy and biologics.
  • Supervise validation activities for engineering projects, ensuring alignment with regulatory standards and internal quality requirements.
  • Develop and implement validation project plans that correspond to risk levels, coordinating efforts with various stakeholders.
  • Manage validation execution stemming from change controls, capital projects, and ongoing revalidation initiatives.
  • Collaborate with Quality Assurance to establish validation strategies that align with site philosophies and regulatory compliance.
  • Act as a subject matter expert (SME) in validation, representing the organization during regulatory inspections and audits.
  • Set clear expectations for compliance with EHS guidelines and cGMP regulations.
  • Foster a culture of continuous improvement by identifying opportunities for process enhancements.
  • Ensure all operations are conducted safely and efficiently, promoting a collaborative environment across departments.
  • Lead and develop a high-performing team, focusing on recruitment, training, and succession planning.
  • Establish performance standards and accountability measures to drive operational excellence.
  • Provide training and mentorship to junior staff in validation practices and regulatory readiness.
Qualifications:
  • A minimum of 10 years of experience in pharmaceutical application validation within a GMP setting.
  • At least 7 years of experience in personnel management and project oversight.
  • In-depth knowledge of cGMP regulations and validation processes.
  • Expertise in equipment, facility, and critical utilities validation.
  • Strong understanding of regulatory requirements, including FDA and EMA guidelines.
  • Proven ability to lead cross-functional teams and manage multiple projects simultaneously.
  • Excellent communication, organizational, and problem-solving skills.
Educational Background:
  • A Bachelor of Science degree in Chemical Engineering, Mechanical Engineering, or a related field is required.
Join Us
At BioSpace, Inc., we are committed to fostering an inclusive and diverse workplace where every employee can thrive. We invite you to explore a career that offers unique opportunities for growth and the chance to make a real difference in the world.

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