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Lead Validation Manager

2 months ago

New Albany, Ohio, United States BioSpace, Inc. Full time
Position Overview

HOW WILL YOU INNOVATE?

At BioSpace, Inc., we believe in the power of collaboration to enhance patient care. Our mission is to push the boundaries of biotechnology, ensuring that our innovations reach millions. Join us in a role that combines leadership with technical expertise.

Lead Validation Manager

Responsibilities

In this pivotal role, you will spearhead a team dedicated to validation initiatives within our organization. Your leadership will be essential in guiding the validation processes for equipment and products, as well as establishing robust procedures for validation lifecycle management.
  • Oversee a team focused on executing site validation tasks.
  • Ensure the initiation, preparation, and completion of all validation documentation and change controls.
  • Direct the formulation of validation strategies and manage the execution of Commissioning & Qualification (C&Q) activities.
  • Coordinate business operations and delegate tasks to support validation efforts.
  • Assess proposed modifications to validated systems and determine necessary validation levels.
  • Manage project timelines and budgets for validation initiatives.
  • Assist in developing system requirements to ensure they are testable and fulfilled.
  • Mentor and guide team members in the execution of validation tasks.
  • Create, review, and approve validation test scripts to ensure compliance with established procedures.
  • Act as the primary representative during audits by regulatory agencies.
Qualifications

We value diverse backgrounds and experiences. The ideal candidate will possess the following qualifications:

Essential Qualifications:
Doctorate degree with 2 years of relevant experience
Or
Master's degree with 4 years of relevant experience
Or
Bachelor's degree with 6 years of relevant experience
Or
Associate's degree with 10 years of relevant experience
Or
High school diploma/GED with 12 years of relevant experience

Additionally, you must have at least 2 years of experience in a managerial capacity, overseeing teams or projects. This leadership experience can coincide with the required technical experience.

Preferred Qualifications:
  • 6+ years of experience in the biotech or pharmaceutical sectors.
  • Extensive experience in Validation for Pharmaceutical/Medical Device processes, particularly with Combination Products.
  • Ability to influence and facilitate discussions among senior team members.
  • Proficient in managing workloads and meeting deadlines.
  • Skilled in negotiating strategic positions based on feedback from various stakeholders.
  • Strong project management, analytical, and problem-solving abilities.
  • Excellent collaboration and communication skills, with experience in presenting to regulatory bodies.
  • Able to thrive in a matrixed environment, engaging with site, functional, and executive leadership.
What We Offer

At BioSpace, Inc., we are committed to the growth and well-being of our employees. We provide a comprehensive benefits package that includes:
  • Health and welfare plans for employees and eligible dependents.
  • Financial plans with opportunities for retirement savings.
  • Work-life balance initiatives and career development programs.
  • Flexible work arrangements, including remote work options where feasible.
Join Us

Be part of a team that is dedicated to making a difference in the lives of patients. Your future begins here.