Senior Validation Engineer

Aerospace, shipbuilding, other transport equipment, Automotive, Electrical, optical, Engineering
Not specified
Contract type:
Full time
Salary description:
Specialist areas:
Quality assurance (main), Audit/assessment, Consultancy, Health and safety, Operational improvement, Project management, Risk management
Start Date:
Seres Therapeutics, Inc.
Job Ref:

Seres Therapeutics is seeking a Senior Validation Engineer to join our dynamic team. Our group is focused on supporting the manufacture of therapeutics for the microbiome by ensuring appropriate implementation of new and existing GMP procedures and facility assets and working to set and meet site manufacturing objectives. This individual is responsible for providing guidance for authoring and maintaining CQV procedures and directives. S/He will also work closely with the Engineering and Facilities team in the development of Site and Department Validation plans. The job requires an individual who can solve highly technical problems of diverse scope, interact with internal and external industry professionals, and consistently demonstrate critical thinking skills. S/He will report directly to the Sr Manager, Facilities & Engineering.

Job Responsibilities

Authors, executes, and summarizes validation protocols for equipment/test instruments, critical utilities
Ensures protocols, records, and procedures are in compliance with current Good Manufacturing Practices (cGMP), industry standards and approved SOPs.
Develops and revises new or existing procedures to ensure compliance to cGMP, GLP, FDA and worldwide regulations.
Provides technical advice on new equipment and modification to existing equipment to ensure validation/qualification status is maintained in a state of control.
Recommends improvements in policies and procedures, to management, to enhance the company's ability to conform to and maintain compliance with site, corporate and regulatory standards.
Coordinates the investigation, impact assessment and resolution for all deviated equipment or processes discovered upon validation or re-validation.
Provide technical assessments on change controls, deviations, and investigations
Work with the Quality team to apply and refine tools for Quality Risk Management
Identify and analyze project risks and guide working groups to develop appropriate mitigation strategies

Required Skills and Qualifications

BS degree in engineering/life sciences or equivalent validation experience. 5-8 years of validation experience in biopharmaceutical, medical device, or FDA regulated environments.
Working knowledge of cGMP, GLP, and FDA regulations related to equipment, utility and process validations. Knowledge of typical pharmaceutical equipment and critical processes.
Must have a working knowledge of the fundamentals of steam sterilization, cleaning validation, equipment and utility qualification (IQ/OQ/PQ)
Excellent written and verbal communications skills
Working knowledge of change management and change control requirements
Experience performing root cause analysis investigations for deviations and non-conformances having technical scope.
Experience working in a highly-regulated environment, particularly biopharmaceutical cGMP procedures
Familiar with GMP processing equipment, both fixed and single use.
In-depth knowledge of cGMP requirements for pharmaceutical or biotechnology environment and understanding of biologics manufacturing and/or bioprocess/product development
Strong understanding and ability to apply ASTM E2500 CQV lifecycle model
Knowledge of global cGMP requirements and expectations as they pertain to validatio
Detail oriented, independently motivated, and possess strong problem-solving abilities

Closing Date:
Contact Details:
Seres Therapeutics, Inc.
Contact: Click apply

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