Senior Process Engineer
Company: BioPharma Consulting JAD Group
Location: Framingham
Posted on: May 13, 2022
Job Description:
BioPharma Consulting JAD Group has a great Senior Process
Engineering role with an industry leader in Framingham, MA. The
Senior Validation Consultant is expected to provide supports to the
process engineering and validation departments. This is a temporary
position (12 months) with the possibility of extension.
Responsibilities include, but are not limited to the
following:
- Demonstrated ability to lead technical projects
- Establish continuous improvement strategies and lead the
proposal, initiation, testing, and implementation of changes to
cell culture and purification processes.
- Participate in Process Validation and Technology Transfer to
internal or external manufacturing facilities.
- Author and/or review documents (technical memos, validation
protocols, reports, etc.) related to process monitoring programs,
at-scale or scale-down studies, annual product reviews, and
non-conformances
- Collaborating with colleagues and floor staff in functional
areas for the implementation of best practices, streamlining of
operations, and equipment handling into SOPs and Manufacturing
Batch Record.
- Communication of project status to Senior Leadership in
multiple forums (as requested), maintaining the metric reporting
for project performance
- Partner cross-functionally across the site to ensure maturity
and execution of robust SOPs and alignment opportunities
- Provide timely and comprehensive progress of project scope and
status updates to senior management
- Help to identify and coordinate a team to include all key
partners and subject matter experts vital for roll out, and
documentation adjustment process
- Basic Qualifications:
- Bachelor's degree in Engineering with 10 years plus of
experience in the pharmaceutical and biotechnology industry
Preferred Qualifications:
- Project Management and Process Engineering skills and
experiences
- Experience leading cross-functional/site investigation teams in
complex deviations including determination of potential product
impact, root cause, and corrective and preventative actions
- Experience in working with multiple, contending priorities in a
fast-paced environment with minimal direction
- Proven leadership traits
- Excellent communication skills, both written and verbal
(including technical writing and presentations) with ability to
collaborate productively with technical and senior management
staff
- Ability to solve complex problems and make scientific
risk-based decisions
- Experience presenting to and interacting with representatives
of regulatory agencies
- Aseptic processing knowledge and/or practical experience
Keywords: BioPharma Consulting JAD Group, Framingham , Senior Process Engineer, Engineering , Framingham, Massachusetts
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