Job Details: Senior Pharmaceutical Engineer Level 3


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
Senior Pharmaceutical Engineer Level 3
JOB DESCRIPTION

My client, a global biopharmaceutical company based in Co. Cork, is
recruiting for a SENIOR PHARMACEUTICAL ENGINEER LEVEL 3 .

This role would be responsible for contributing to the technical
management and oversight of multiple commercial pharmaceutical
products, in the following ways:

Oversees and contributes to the completion of all technical and
operational activities related to maintaining commercial product
supplies through management of internal and external resources.

Responsible for lifecycle management of commercial products including
scale-up, validation, Continued Process Verification and technology
transfer between sites to ensure production schedules are met.

Leads activities at manufacturing sites, including providing project
timelines, resolving issues, on-site troubleshooting, and providing
overall technical support; may negotiate pricing for limited-scope
projects.

Leads technical investigations and assessment of deviations and CAPAs

Defines requirements for, and reviews master batch records.

Coordinates equipment/process qualification (IQ/OQ/PQ) and executes
process validation (PV); writes, reviews and/or approves
qualification/validation/technical reports.

Responsible for the development, distribution, updating and
maintenance of the technical database for all CMOs currently used by
the company in the manufacturing of commercial products.

Responsible for tracking and updating senior management on the routine
manufacturing of commercial products providing guidance on potential
problems and their resolution.

Prepares documents for Regulatory filings, and reviews filings,
including sections from other disciplines. Responsible for the
technical review of pertinent CMC sections of global regulatory
filings.

Manages complex processes across functions and interacts effectively
with the other team members to ensure product meets regulatory,
performance, and cost requirements.

Provides technical guidance and training to junior group members.

Qualification and Skills Required:

BS or MS degree in Engineering or Science field, preferably in
Chemical Engineering, Pharmaceutical Sciences/Engineering or
Mechanical Engineering.

Good understanding of/experience with applied statistics and data
analysis.

Strong knowledge of Good Manufacturing Practices (GMPs) and working
knowledge of regulatory filing requirements and guidance documents
(i.e. SUPAC, PACPAC).

Strong computer, organizational, and project management skills
required.

8+ years of experience in the pharmaceutical industry and a BS or BA.

6+ years of relevant experience and a MS.

MUST HAVE EXPERIENCE WITH INJECTABLES AND SOLID PHARMACEUTICAL

JOB DESCRIPTION

My client, a global biopharmaceutical company based in Co. Cork, is
recruiting for a SENIOR PHARMACEUTICAL ENGINEER LEVEL 3 .

This role would be responsible for contributing to the technical
management and oversight of multiple commercial pharmaceutical
products, in the following ways:

Oversees and contributes to the completion of all technical and
operational activities related to maintaining commercial product
supplies through management of internal and external resources.

Responsible for lifecycle management of commercial products including
scale-up, validation, Continued Process Verification and technology
transfer between sites to ensure production schedules are met.

Leads activities at manufacturing sites, including providing project
timelines, resolving issues, on-site troubleshooting, and providing
overall technical support; may negotiate pricing for limited-scope
projects.

Leads technical investigations and assessment of deviations and CAPAs

Defines requirements for, and reviews master batch records.

Coordinates equipment/process qualification (IQ/OQ/PQ) and executes
process validation (PV); writes, reviews and/or approves
qualification/validation/technical reports.

Responsible for the development, distribution, updating and
maintenance of the technical database for all CMOs currently used by
the company in the manufacturing of commercial products.

Responsible for tracking and updating senior management on the routine
manufacturing of commercial products providing guidance on potential
problems and their resolution.

Prepares documents for Regulatory filings, and reviews filings,
including sections from other disciplines. Responsible for the
technical review of pertinent CMC sections of global regulatory
filings.

Manages complex processes across functions and interacts effectively
with the other team members to ensure product meets regulatory,
performance, and cost requirements.

Provides technical guidance and training to junior group members.

Qualification and Skills Required:

BS or MS degree in Engineering or Science field, preferably in
Chemical Engineering, Pharmaceutical Sciences/Engineering or
Mechanical Engineering.

Good understanding of/experience with applied statistics and data
analysis.

Strong knowledge of Good Manufacturing Practices (GMPs) and working
knowledge of regulatory filing requirements and guidance documents
(i.e. SUPAC, PACPAC).

Strong computer, organizational, and project management skills
required.

8+ years of experience in the pharmaceutical industry and a BS or BA.

6+ years of relevant experience and a MS.

MUST HAVE EXPERIENCE WITH INJECTABLES AND SOLID PHARMACEUTICAL



We need : English (Good)

Type: Permanent
Payment:
Category: Others

Apply for this Job Offer
Name: (*) 
Email: (*) 
Phone: (*) 
Please Provide a Cover in the English Language.
CV: (*) 
Are you human ?
Share on your Facebook Page: