Job Details

TBF/FBF Contractor Job Description

Make sure to apply with all the requested information, as laid out in the job overview below.

This role is responsible for providing scientific and technical support of product launches, technology transfers, and new technology introduction to the FDBT site. The selected candidate will be accountable for performing activities such as Cycle Development (CD), Commissioning and Qualification, Performance Qualification (PQ) / Periodic Reviews (PR) and will closely collaborate across the site and occasionally works with other network organizations. Focus will also be placed on right first time execution and continuous improvement.

Education Requirements:

20+ years of validation experience within the life sciences industry.

Minimum BS / BA Engineering or Science

Key Requirements:

Experience in the creation of validation Life Cycle Documentation (URS, FRS, DS, and other engineering specifications), Validation (VPP, IQ, OQ, PQ, System Impact Assessment, Requirements Traceability Matrix, Final Report, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, Standard Operating Procedures, etc).

Strong understanding of validation processes and regulatory requirements.

Outstanding capability to independently resolve and communicate technical issues.

Ability to lead cross-functional teams and coordinate complex projects.

Implement and manage detailed project plans and timelines for the execution of IQ/OQ/PQ/RQP activities.

Working knowledge and expertise in computerized systems validation.

Support deviations and change records & CAPA actions, completes validation studies & performs problem solving. Support Investigations and atypical events, as well as resulting corrective or preventive action implementation.

Participate in the implementation of new process technologies in alignment with business objectives or regulatory requirements.

Own and support validation performed by vendors ensuring is complete and accurate, work with vendors for issue resolution, validation deviation reporting, and generate summary reports based on vendor protocol results.

Coordinate and execute. tactical validation activities, including sample collection, coordinating with multi-functional support teams, retrieving data and results, completing documentation, as required per protocols.

Excellent technical writing abilities for creation and updates on Standard Operating Procedures.

Proficient in Microsoft Word, Excel, PowerPoint.

Must be able to work independently with adequate supervision, multi-task, and support several projects simultaneously.

Offer support to less experienced members of the team.

Perform other assigned duties.

Must be available to work as needed including holidays and weekends.

Remote work not allowed.

Areas of expertise:

Kneat electronic Validation documentation

Experience with Data Loggers as well as pre and post calibration procedures.

Cold rooms, freezers, refrigerators, incubators temperature mapping proficient

Autoclaves and cycles development.

EMPQ's.

Biowelders

Culture chemistry analyzer

Smoke Studies

Fillers

VHP Decontamination and cycle development.

Bioquells Qube.

Mixers

Tanks

VCells

Akta

Filter Integrity testers

Pumps

Centrifuge

Down flow hood

Weight Scales

SME Water Systems (WFI, RODI)

Clean Gas Utilities

Facilities