Validation Consultant

2 months ago

Pennington, United States I3 INFOTEK INC Full time

General Description:

Responsible for providing quality oversight for the qualification and validation activities for equipment, utilities, and facilities. This role will be responsible for drafting, reviewing and approving qualification protocols/reports and any associated documentation in support of CQV activities for a new facility. The Role also need to drive the validation activity close out.


Essential Functions of the job:

  • Assist in development, review, and approval of cGMP documents including, but not limited to: Master Validation Plans, FAT/SAT documents, Turnover Packages, SOP’s, specifications, traceability matrices, thermal mapping documents, and design documentation.
  • Provide expertise and solutions to issues regarding CQV Lifecycle documentation in regards for applicable FDA/EMEA Regulations
  • Support validation activities for project activities including review of validation documentation (FAT, SAT, URS, SDS, IQ, OQ, PQ) and attendance at validation activities.
  • Provide support to enforce CQV guidelines, policies and procedures for equipment, analytical equipment, utilities, and facilities (Examples: Bioreactor, Incubator Chromatography Systems, harvest hold tank, washers, autoclaves, etc.)
  • Main focus of this role will be to Qualify Clean Rooms. Past experience with balance reports, hepa filter certs, and all associated utilities and equipment.
  • Employee will be required to work closely with Manufacturing, Validation, Site Automation, Engineer, Quality Control, and Global Technical Operations (GTS) associates.
  • Ensuring appropriate investigation of validation discrepancies, errors, protocol failures, or validation testing errors requiring documented review and action to reconcile deviations.
  • Undertaking any other duties for any department within the business, which may be requested by the Manager, for which training and/or an explanation has been provided and understood.


Core Competencies, Knowledge, and Skill Requirements

  • Scientific degree (ideally: pharmaceutical sciences, engineering, chemistry, or related discipline).
  • Minimum of 5 years’ experience in validation, biological quality assurance and/or quality control in an FDA-regulated biotechnology or pharmaceutical company with progressive levels of responsibility.
  • 1-3 years in a quality assurance or quality control role in an FDA-regulated company
  • Strong knowledge of cGMP’s 21CFR parts 2010 & 211, knowledge of 21CFR600 – Biologics desirable.
  • Demonstrated knowledge of ISPE Baseline Guide 5, ASTM E-2500, EU regulatory requirements, and GAMP 5 Validation Lifecycle.
  • Knowledgeable in risk assessments and process for following well documented and thought through risk-based approaches.
  • Demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
  • Good collaboration and good project management skills.
  • Credible and confident communicator (written and verbal) at all levels.
  • Customer focused, Strong analytical and problem-solving ability.
  • Hands-on approach, with a ‘can do’ attitude. Able to work under minimal supervisor.
  • Ability to prioritize, demonstrating good time management skills.
  • Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
  • Self-motivated, with the ability to work proactively using own initiative.
  • Committed to learning and development.
  • Highly Desirable: Good IT skills e.g., Microsoft Office (Word, Excel, PowerPoint, Project and Outlook).


Significant Contacts

Manufacturing, Validation, Site Automation, Engineer, Quality Control, and Global Technical Operations (GTS) associates

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