PROCESS ENGINEER - DRUG SUBSTANCE 
PFIZER PHARMACEUTICALS - GRANGE CASTLE
JOB PURPOSE:
Provide process science and engineering, manufacturing technology and
validation support to the ongoing requirements of the Bioprocessing
operating unit as well to support process tech transfer projects into
site. Responsibility is to ensure that the appropriate equipment and
process conditions are used to affect the desired process, ensure that
the process is running as intended, that it is appropriately validated
and executed to maintain the validated state.
This role focuses on process monitoring and trouble-shooting,
including leading process investigations, implementation of cost
reduction projects, facility and equipment design, knowledge capture
from donor sites, assisting in technology transfer execution including
process trials on the bench or at scale in support of these project
objectives and execution of final process validation studies and
write-ups.
The job-holder works with the Technical Services Teams to deliver
integrated technical services to meet the site business objectives.
The role requires the flexibility to move from one project quickly or
to work on multiple smaller projects at the same time.
JOB RESPONSIBILITIES:
* Carry out process monitoring of commercial processes and work to
improve process capability where weaknesses are identified.
* Lead major process investigations as requested and support the
implementation of CAPAs.
* Write product/process impact assessments in support of
investigation closures.
* Work to implement a culture of Right-First Time through
partnerships with Operations and other functions on site and provide
leadership in the use of OE principles to optimise our technical and
business processes.
* Lead cross site process improvement projects.
* Act as process SME in regulatory inspections.
* Liaise with site functions ? logistics, planning, QA, QC,
Operations, Regulatory Affairs to support the process transfer to GC
* Model the running of the facility with Operations ? number of
batches, scale of equipment, facility sizing and layout, etc
* Ensure the process automation meets the requirements of the
process
* Assist in the raising and execution of change controls for
Technical Services
* Provide process expertise for trouble-shooting and resolution of
manufacturing process and technology issues.
* Provide process engineering expertise to support from preliminary
engineering through to the end of process validation and delivery of
the facility to Operations.
* Provide technical training on process and technology areas as
required by the project.
* Support Compliance Inspections and enquiries from Regulatory
Agencies.
* Develop and maintain productive links with process equipment &
technology supplier and vendors.
* Prepare and execute process and cleaning validation protocols.
* Work as part of product technical team to support goals of the
product franchise.
* Support continuous improvement projects within the operating unit.
SF1
EXPERIENCE: 
1. Ideally minimum **Apply on the website** Years cGMP industrial
experience in a technical support role, covering Operations,
Engineering, Projects and Validation within bioprocess manufacturing.
2. In depth understanding of process engineering including
biotechnology, purification technology and unit operations, potential
impact of equipment on biological molecules.
3. Strong track record delivering improvement and robustness projects
on time and in full
4. Experience with technology transfer and project engineering
preferred.
5. Strong understanding of process and cleaning validation
requirements for bioprocessing with particular emphasis on continued
process verification
6. Experience of FDA and EU licensing and inspection.
7. Demonstrated aptitude for technical learning and problem solving.
8. Ability to utilize lean six sigma tools to drive continuous
improvement.
9. Experience working as part of a cross functional team to deliver on
site goals.
EDUCATION:
Minimum qualification of a B. Sc. Degree in Engineering, Bioprocess
Science, Chemistry, Biotechnology or equivalent with particular
emphasis in Biochemical, Chemical or Mechanical discipline. Higher
degree would be preferred.
JOB DESCRIPTION
PROCESS ENGINEER - DRUG SUBSTANCE 
PFIZER PHARMACEUTICALS - GRANGE CASTLE
JOB PURPOSE:
Provide process science and engineering, manufacturing technology and
validation support to the ongoing requirements of the Bioprocessing
operating unit as well to support process tech transfer projects into
site. Responsibility is to ensure that the appropriate equipment and
process conditions are used to affect the desired process, ensure that
the process is running as intended, that it is appropriately validated
and executed to maintain the validated state.
This role focuses on process monitoring and trouble-shooting,
including leading process investigations, implementation of cost
reduction projects, facility and equipment design, knowledge capture
from donor sites, assisting in technology transfer execution including
process trials on the bench or at scale in support of these project
objectives and execution of final process validation studies and
write-ups.
The job-holder works with the Technical Services Teams to deliver
integrated technical services to meet the site business objectives.
The role requires the flexibility to move from one project quickly or
to work on multiple smaller projects at the same time.
JOB RESPONSIBILITIES:
* Carry out process monitoring of commercial processes and work to
improve process capability where weaknesses are identified.
* Lead major process investigations as requested and support the
implementation of CAPAs.
* Write product/process impact assessments in support of
investigation closures.
* Work to implement a culture of Right-First Time through
partnerships with Operations and other functions on site and provide
leadership in the use of OE principles to optimise our technical and
business processes.
* Lead cross site process improvement projects.
* Act as process SME in regulatory inspections.
* Liaise with site functions ? logistics, planning, QA, QC,
Operations, Regulatory Affairs to support the process transfer to GC
* Model the running of the facility with Operations ? number of
batches, scale of equipment, facility sizing and layout, etc
* Ensure the process automation meets the requirements of the
process
* Assist in the raising and execution of change controls for
Technical Services
* Provide process expertise for trouble-shooting and resolution of
manufacturing process and technology issues.
* Provide process engineering expertise to support from preliminary
engineering through to the end of process validation and delivery of
the facility to Operations.
* Provide technical training on process and technology areas as
required by the project.
* Support Compliance Inspections and enquiries from Regulatory
Agencies.
* Develop and maintain productive links with process equipment &
technology supplier and vendors.
* Prepare and execute process and cleaning validation protocols.
* Work as part of product technical team to support goals of the
product franchise.
* Support continuous improvement projects within the operating unit.
SF1
EXPERIENCE: 
1. Ideally minimum **Apply on the website** Years cGMP industrial
experience in a technical support role, covering Operations,
Engineering, Projects and Validation within bioprocess manufacturing.
2. In depth understanding of process engineering including
biotechnology, purification technology and unit operations, potential
impact of equipment on biological molecules.
3. Strong track record delivering improvement and robustness projects
on time and in full
4. Experience with technology transfer and project engineering
preferred.
5. Strong understanding of process and cleaning validation
requirements for bioprocessing with particular emphasis on continued
process verification
6. Experience of FDA and EU licensing and inspection.
7. Demonstrated aptitude for technical learning and problem solving.
8. Ability to utilize lean six sigma tools to drive continuous
improvement.
9. Experience working as part of a cross functional team to deliver on
site goals.
EDUCATION:
Minimum qualification of a B. Sc. Degree in Engineering, Bioprocess
Science, Chemistry, Biotechnology or equivalent with particular
emphasis in Biochemical, Chemical or Mechanical discipline. Higher
degree would be preferred.
We need : English (Good)
Type: Permanent
Payment:
Category: Others
