Executes and/or Leads installation, operational and performance qualification (IQ/OQ/PQ) of area specific process equipment, validation of SIP/CIP processes, qualification of environmental chambers and qualification of critical process utility systems.
Provides Single Point of Contact (SPOC) on all validation activities for a specific manufacturing area (Production Support, Cell Culture, Purification, and Critical Utilities), working with designated peers to create a team/triage environment.
Assignment of SPOC to designated manufacturing area is based on demonstrated technical knowledge and experience with associated equipment/systems.
Provides validation subject matter expertise (SME) and leads multi-function teams, advises operations on validation matters, and defends the associated validation testing and summary reports to regulatory agencies, with oversight from Validation management.
Leads validation projects whose scope, regulatory visibility, schedule requirements, and complexity require involvement in establishing informed risk-based decisions and coordination with stakeholders, collaborators, and quality assurance.
Executes validation work arising from change controls, capital projects, shutdown/changeover activity, and ongoing validation lifecycle programs.
For novel projects, this individual works with Quality Assurance, consulting Validation management as needed, to establish appropriate validation methodologies.
Leads a portfolio of validation projects under strict deadlines to ensure stakeholder success and bulk drug supply. Leads projects while serving as an individual contributor of technical work and a point of contact for project stakeholders and cross-functional team members.
Provides validation subject matter expertise (SME) and contributes to multi-function teams, advises operations on validation matters, and defends their work before regulatory agencies, with oversight from management.
Maintains familiarity with BMS directives and industry guidelines on qualification/validation. Provides, in addition to operations support, internal compliance and/or efficiency improvement efforts within department for more complex processes.
Knowledge of engineering and science generally attained through studies resulting in a B.S., in engineering (chemical preferred), a related discipline, or its equivalent.
A minimum of 6 years relevant experience in a Validation role in the biopharmaceutical industry or its equivalent.
Direct experience with process equipment and system qualification, sterilization qualification, critical utilities validation, cleaning validation, and temperature mapping is required.
Knowledge of distributed control systems and automation (GAMP) validation concepts suggested.
A working understanding of six sigma and lean principles suggested.
Demonstrated proficiency in project management, communication, and technical writing skills suggested.
Possess the professionalism and technical competency required to directly support the department before our stakeholders, regulatory agencies, and management.
Working knowledge of SOPs, cGMPs and compliance requirements and regulatory guidelines (FDA, EU) and the general understanding to work within a regulatory environment.
Ability to handle difficult and unusual tasks, often using creative problem-solving.
Demonstrated track record of developing and implementing logical and optimal plans to achieve objectives.
Provides technical expertise to management and lower level professionals.
Ability to sense, understand, and react to others emotions and recognize the impact of their emotions on your and other's performance and behaviors.
A candidate for this position should:
Exercise sound judgment in making decisions and recommendations within generally defined practices and policies without management review. May make decisions and take action on standard cases without management review. May work on assignments that are extremely complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations. Acts as an advisor to subordinates and becomes actively involved as required to meet schedules or resolve problems. Erroneous decisions or failure to achieve results may have significant financial implications or cause significant delays in schedules. Associated topics: bio, bioengineering, biomaterials, biomedical, bioprocess, bioprocessing, enzyme, molecular, neuro, neurodegenerative
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.