Mentor Technical Group
CQV Specialist – Upstream Process Equipment
Mentor Technical Group, Juncos, Juncos, us, 00777
Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.
Responsibilities:
Develop, review, and execute
Commissioning, Qualification, and Validation (CQV) protocols
for upstream process equipment (IQ, OQ, PQ).
Support
equipment design reviews
and provide validation input during procurement and installation phases.
Perform
risk assessments
and identify critical quality attributes (CQAs) and critical process parameters (CPPs).
Document and report
validation results , deviations, and corrective actions in compliance with internal procedures and regulatory standards.
Collaborate with
engineering, manufacturing, and quality teams
to ensure seamless equipment qualification and process transfer.
Maintain and update
validation documentation
for existing and new upstream process equipment.
Support
regulatory inspections and audits , providing necessary documentation and evidence of compliance.
Provide
training and guidance
on equipment operation and validation procedures to team members.
Qualifications / Requirements: Bachelor’s degree in
Biochemical Engineering, Chemical Engineering, Biotechnology, or related field .
Minimum of
3-5 years of experience
in CQV for upstream bioprocess equipment in
pharmaceutical or biopharmaceutical industry .
Strong knowledge of
cGMP, FDA, EMA, and ICH guidelines .
Experience with
bioreactors, fermenters, cell culture systems, and related upstream equipment .
Proficiency in
protocol writing, validation reports, and deviation management .
Strong analytical and problem-solving skills.
Excellent
communication and team collaboration skills .
Ability to manage multiple projects and meet tight deadlines.
Preferred: Experience with
single-use systems
and advanced upstream bioprocess technologies.
Knowledge of
automation, SCADA systems, and process control .
Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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Commissioning, Qualification, and Validation (CQV) protocols
for upstream process equipment (IQ, OQ, PQ).
Support
equipment design reviews
and provide validation input during procurement and installation phases.
Perform
risk assessments
and identify critical quality attributes (CQAs) and critical process parameters (CPPs).
Document and report
validation results , deviations, and corrective actions in compliance with internal procedures and regulatory standards.
Collaborate with
engineering, manufacturing, and quality teams
to ensure seamless equipment qualification and process transfer.
Maintain and update
validation documentation
for existing and new upstream process equipment.
Support
regulatory inspections and audits , providing necessary documentation and evidence of compliance.
Provide
training and guidance
on equipment operation and validation procedures to team members.
Qualifications / Requirements: Bachelor’s degree in
Biochemical Engineering, Chemical Engineering, Biotechnology, or related field .
Minimum of
3-5 years of experience
in CQV for upstream bioprocess equipment in
pharmaceutical or biopharmaceutical industry .
Strong knowledge of
cGMP, FDA, EMA, and ICH guidelines .
Experience with
bioreactors, fermenters, cell culture systems, and related upstream equipment .
Proficiency in
protocol writing, validation reports, and deviation management .
Strong analytical and problem-solving skills.
Excellent
communication and team collaboration skills .
Ability to manage multiple projects and meet tight deadlines.
Preferred: Experience with
single-use systems
and advanced upstream bioprocess technologies.
Knowledge of
automation, SCADA systems, and process control .
Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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