chemical / biochemical / pharmaceuticals/ fill- packaging  /  R&D/ Manufacturing/ productivity solutions/ project
plans/testing-validation-control/  write SOP's / regulatory reports


VUWK4331

Director of Research & Development

Process Engineering - Operations

West Portland, OR


In the P R & D Department:

Accountable for validation activities such as FATs and IQ/OQ/PQ
activities for the fill/packaging facilities in Oregon

* Able to collaborate with both plant and corporate
organizations seamlessly.
* Is constantly in search of the most creative and innovative
solutions to maintaining the highest levels of productivity.
* Is able to provide the leadership necessary to maintain a
high performance culture.

Responsibilities:
* Develop, execute, and manage the detailed project plans and
timelines for the execution of factory acceptance testing (FAT) and
IQ/OQ/PQ activities.
* Plan and execute factory acceptance testing (FAT) and
IQ/OQ/PQ activities.
* Prepare validation & change control, documentation,
including protocols, summary reports, etc., for validation
activities.
* Act as project manager for validation teams ensuring new
systems are implemented within predetermined timelines and financial
forecasts.
* Present and provide rationale for the validation program
during periodic audits and regulatory inspections.
* Procure and manage contractor support for outsourced
validation assignments.
* Coordinate the collection, testing and analysis of samples
and reporting of results required per validation protocol.
* Support the change management system for validated
equipment, utilities and facilities.
Prepare, review and approve relevant sections of regulatory
submissions.
* a representative on cross-functional and multi-site teams.
* Lead and facilitate the development of formulation, filling,
and packaging, area SOP's and manufacturing documents as appropriate.
* Foster an environment that encourages continuous learning.
Maintain expertise as necessary to stay abreast of technical and
industry advancements.
* Manage the development and implementation of unique approaches
to solving complex technical problems

 

Experience/Skills/Education

* BS/MS in chemical, biochemical engineering, or related
field/experience, with a minimum of 10 (ten) years experience in drug
product Process Research & Development, Engineering, Manufacturing,
or Technical Services is required.
* Experience in the pharma/biotech industry
* Knowledge of cGMPs or equivalent regulations
* Working knowledge of formulation, filling, and, packaging,
equipment qualification in a regulated environment
* 6 years of demonstrated project management skills
* Ability to work with internal teams, partners, suppliers and
customers
* Operational excellence and industrial engineering skills are
a plus
* Up to 20% Travel