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Sr. Manager, Validation

Employer
iBio, Inc.
Location
Bryan, TX
Start date
May 12, 2022

View more

Discipline
Engineering, Validation Engineer
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Lone Star Bio

At iBio, we’re growing tomorrow’s biologics with ourFastPharming®Systemfor high-quality, eco-friendly production of recombinant proteins using plants. At our 130,000 square foot manufacturing facility and headquarters in Bryan, Texas, we combine vertical farming, automated hydroponics, and molecular biology to produce therapeutics, vaccines and products for life science research and bioprocessing. We’re putting these capabilities to work for our clients via our array ofcontract development and manufacturing services, as well as deploying them for the advancement of our ownpipelineof therapeutics, vaccines, and products for research & bioprocessing applications. We’ve recently expanded our footprint to San Diego where our early-stage drug discovery team is pioneering the next generation of biopharmaceuticals for the treatment of cancers, as well as fibrotic and infectious diseases.

Just imagine what we can do together! We know extraordinary things happen when individual talent, technology, and a great mission cross paths: the opportunity to create an outstanding team and a world-class company. We are looking to hire exceptional people who have demonstrated track records of success to continue to build a leading biotechnology and development services organization.

Apply now for our Sr. Manager, Validation position and help bring the power of plants to the biopharmaceutical industry!

MISSION OF THE POSITION

The Sr. Manager, Validation will be a team player in a small company environment in this highly cross-functional role. He/She will be responsible for all activities for the validation department, including the scheduling and execution of qualifications and validations of manufacturing facilities, utilities, equipment, and processes and overseeing the site Master Validation Plan.

WORK LOCATION

The Sr. Manager, Validation position is located in Bryan, Texas.

ESSENTIAL DUTIES & RESPONSIBILITES

  • Oversee the site Master Validation Plan, using input from internal and external resources for continuous improvement. Creates, coordinates, and enforces Validation systems, policies, and procedures
  • Responsible for periodic assessment and requalification program, PPQ (Process Performance Qualification), Cleaning and CSV (Computer System Validation)
  • Manage validation department personnel; hire, train, coach, and develops staff within the Validation team
  • Monitor the performance of the validation department by tracking appropriate metrics and reporting the results to management.
  • Responsible for the day-to-day activities conducted by the Validation Department; establishes priorities to ensure that deadlines are met and budgets are not exceeded
  • Liaise with outside vendors as a representative of validation and supervises the activities of external validation contractors
  • Oversee development and approval of Validation SOPs and validation-specific documents
  • Support commissioning activities, projects, and validation functions by performing, preparing and reviewing/approving validation protocols and other documentation. Generate validation final reports as needed
  • Act as the Validation SME for manufacturing operations
  • Assess change controls with an accurate understanding of the bigger picture implications of changes
  • Communicate validation activities and schedules to other departments as required
  • Work closely with cross functional teams to ensure all work is completed to high quality in a timely and scientifically rigorous manner

KNOWLEDGE, SKILLS, & ABILITIES

  • Working knowledge of validation and GxP requirements for biologics manufacturing
  • Working knowledge of requirements for aseptic manufacturing
  • Familiarity with multi-product manufacturing facility
  • Ability to operate Kaye (or other) validation equipment and interpret resulting data and discussing validation policies and philosophies during audits/inspections by internal and external entities
  • Ability to interpret cGMP requirements
  • Ability to forecast and manage and prioritize multiple projects or assignments at one time, including the ability to follow assignments through to completion and meet deadlines
  • Must have strong organizational skills and excellent communication (verbal and written) skills
  • Problem-solving skills and ability to make quality decisions based on technical facts and sound risk assessments is required

EDUCATION & EXPERIENCE

  • Bachelor's degree or equivalent in related technical discipline required
  • Master's degree in related technical discipline preferred
  • 5 plus years of relevant experience in validation in the biotech/pharmaceutical industry required
  • Management experience within a validation department required
Accessibility: If you need an accommodation as part of the employment process please contact Human Resources at
Phone: 979-446-0266
Email: bridget.mapes@ibioinc.com

Equal Opportunity Employer, including disabled and veterans.

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