Job Details: Senior Pharmaceutical Engineer- Aseptic


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
Senior Pharmaceutical Engineer- Aseptic
DESCRIPTION

Senior Pharmaceutical Engineer - Aseptic Processing: Cork

KEY RESPONSIBILITIES:

Responsible for contributing to the technical management and oversight
of multiple injectable commercial pharmaceutical products, as follows:

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

Technical expertise in parenteral manufacturing areas such as
compounding, aseptic filling, lyophilization, capping, inspection,
aseptic practices, sterility assurance studies

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
CAPA?s

Defines requirements for, and reviews master batch records.

Co-ordinates 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 CMO?s currently used
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.

Motivated individual, who can work independently, with effective
planning and prioritisation skills.

Excellent analytical/ problem solving skills.

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

Excellent verbal, written, and interpersonal communication skills,
with experience writing technical reports.

Strong knowledge of Good Manufacturing Practices (GMPs), working
knowledge of regulatory filing requirements and guidance documents
(i.e. SUPAC, PACPAC) and compliance for sterile injectable products
manufactured by aseptic processing.

Strong computer, organizational, and project management skills
required.

Ability to function well in small technical groups in a dynamic,
fast-paced work environment, working on multiple, time-sensitive
projects.

Relevant experience in the pharmaceutical industry.
DESCRIPTION

Senior Pharmaceutical Engineer - Aseptic Processing: Cork

KEY RESPONSIBILITIES:

Responsible for contributing to the technical management and oversight
of multiple injectable commercial pharmaceutical products, as follows:

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

Technical expertise in parenteral manufacturing areas such as
compounding, aseptic filling, lyophilization, capping, inspection,
aseptic practices, sterility assurance studies

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
CAPA?s

Defines requirements for, and reviews master batch records.

Co-ordinates 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 CMO?s currently used
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.

Motivated individual, who can work independently, with effective
planning and prioritisation skills.

Excellent analytical/ problem solving skills.

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

Excellent verbal, written, and interpersonal communication skills,
with experience writing technical reports.

Strong knowledge of Good Manufacturing Practices (GMPs), working
knowledge of regulatory filing requirements and guidance documents
(i.e. SUPAC, PACPAC) and compliance for sterile injectable products
manufactured by aseptic processing.

Strong computer, organizational, and project management skills
required.

Ability to function well in small technical groups in a dynamic,
fast-paced work environment, working on multiple, time-sensitive
projects.

Relevant experience in the pharmaceutical industry.


We need : English (Good)

Type: Permanent
Payment:
Category: Others

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