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Quality Assurance Validation Specialist

2 months ago

Baltimore, Maryland, United States BioSpace, Inc. Full time
Position Overview


At BioSpace, Inc., we tackle significant public health challenges to safeguard and improve the lives of millions, contributing to a more secure future.

Join a team of dedicated professionals committed to enhancing their scientific, technical, and professional expertise to develop products aimed at protecting and improving life.



ROLE SUMMARY

Oversee and prioritize all stages of assigned validation initiatives from inception through process validation and ongoing support of cGMP operations. Ensure compliance with cGMP regulations by adhering to site and corporate validation Plans, Policies, and Procedures.

Contribute at a high level in at least two of the following areas: Commissioning and Qualification, Sterility Assurance, Cleaning Validation, Computer Systems Validation, Validation Maintenance/Risk Management, and Application of Statistical Techniques.


KEY RESPONSIBILITIES
Accommodations will be made to enable individuals with disabilities to perform essential functions.

  • Possess extensive knowledge of validation practices and related regulations
  • Plan, coordinate, and execute assigned projects utilizing effective Project Management methodologies
  • Review and approve validation-related system lifecycle design documentation (user requirements, functional and design specifications, commissioning, and qualification protocols)
  • Conduct hands-on fieldwork for equipment, aseptic processing, steam sterilization, cleaning validation, and process validation along with their associated control systems
  • Employ proven monitoring and problem-solving techniques such as SPC and DMAIC
  • Provide customer-focused support to engineering, research and development, quality, manufacturing sciences and technology, and manufacturing as a Subject Matter Expert and leader within the Validation department
  • Address a variety of complex problems requiring analysis and interpretation, utilizing knowledge, skills, precedents, and practices, including process troubleshooting, operations support, root cause analysis, and risk assessment
  • Mentor and coach other members of the EFV and project teams to foster continuous improvement, knowledge transfer, and professional development
  • Identify opportunities to reduce project costs through lessons learned and develop specific strategies to achieve these savings
  • Demonstrate a comprehensive understanding of work; creatively resolve a wide range of issues
  • Tackle increasingly diverse problems; analyze situations/data requiring evaluation of identifiable factors
  • Exhibit sound judgment in selecting methods and techniques for problem resolution and solution attainment
  • Operate with minimal supervision, receiving general instructions on new assignments
  • Drive the successful execution of assigned projects, ensuring high engagement from project team members
The above statements are intended to describe the general nature of work performed by individuals in this role. It is not an exhaustive list of all duties, and additional responsibilities may be assigned.

MINIMUM EDUCATION, EXPERIENCE, AND SKILLS

  • A minimum of 5 years of experience in a biopharmaceutical or related environment focused on system qualification or validation
  • Bachelor’s degree in Engineering, Science, or Project/Program Management
  • Technology/Equipment emphasis will vary by site; candidates are expected to guide operations to achieve top-tier safety, efficiency, and compliance
  • Ability to think and act both strategically and tactically
  • Highly effective verbal and written communication skills at all organizational levels
  • Proven ability to prioritize and coordinate activities effectively
  • Proficiency in Microsoft Office applications and validation-specific software programs
  • Strong problem-solving and critical thinking abilities with a demonstrated capacity to conduct technical programs and achieve program goals; excellent organizational skills to manage and delegate multiple projects of varying complexity
  • Knowledge of current validation best practices, including governmental regulations and GxPs
  • Subject Matter Expertise in one of the following Validation disciplines: Commissioning and Qualification, Sterility Assurance, Cleaning Validation, Computer Systems Validation, Validation Maintenance/Risk Management, and Application of Statistical Techniques


BioSpace, Inc. is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce.
BioSpace does not discriminate based on race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information, or any other characteristics protected by applicable federal, state, or local law.

Information submitted will be used by BioSpace, Inc. for activities related to your prospective employment.
BioSpace respects your privacy, and any use of the information submitted will be subject to the terms of our Privacy Policy.


BioSpace does not accept unsolicited resumes or candidate submissions from search/recruiting agencies not already on BioSpace's approved agency list.

Unsolicited resumes or candidate information submitted to BioSpace by search/recruiting agencies not already on BioSpace's approved agency list shall become the property of BioSpace, and if the candidate is subsequently hired by BioSpace, BioSpace shall not owe any fee to the submitting agency.