Role Summary:

  • A new vacancy for an experienced Process Engineer exists on our clients site based in Co. Westmeath.
  • The Process Engineer is responsible for the operation of the process equipment on site.
  • The successful candidate will provide technical leadership in the areas of yield improvement, reliability, process control, manufacturing support, manufacturing process troubleshooting and product transfer.
  • The Process Engineer will report to the Senior Manager Technical Services.

Core Duties and Responsibilities:

  • Has ownership of process equipment line reliability. Ensuring that any process equipment related plant downtime is quickly and reliably resolved in a cGMP compliant manner. Identify the short, medium and/ or long-term fixes for the downtime and manages the implementation of these fixes.
  • Pro-actively identify risks to the security of site manufacturing supply. Lead cross functional teams in projects to mitigate these risks.
  • Works with manufacturing and quality colleagues as part of an Operations team whose shared goal is to realise the safety, quality, delivery and cost objectives of the site.
  • Prioritises safety and is diligent in the use of all appropriate safety tools and permits when maintaining equipment – champions safe working always.
  • Is the process SME for the products, supporting or leading product related deviations, change controls and CAPAs.
  • Supports manufacturing by leading/supporting deviation investigations and is familiar with structured problem solving and root cause analysis.
  • Supports validation activity in process manufacturing areas.
  • Leads continuous improvement projects and initiatives and is owner of yield performance, cycle time improvement and capacity increase.
  • Provides technical support for product APRs (Annual Product Review)
  • Provides training and mentoring to build technical capabilities among teams.
  • Supports capital projects throughout equipment lifecycle.
  • The role will typically require infrequent, off-site national and international travel, for business or equipment/project review meetings, including overnight stays, up to 10% of the time.

Minimum Qualifications and Experience:

  • Bachelors Degree in Engineering, Pharmaceutical Sciences, or related Science discipline; further qualification (Masters) in related discipline ideal.
  • At least 5 years relevant experience in a pharmaceutical manufacturing environment, with at least 3 years experience in a comparable process engineering/technical services role.
  • Must have experience working in a sterile manufacturing environment.
  • Ophthalmic manufacturing experience a plus.
  • Experience with many of the following processes:
    • Vial or bottle filling of sterile solutions
    • Compounding – dispensing, formulation, sterile filtration, etc.
    • Isolator technology incl. VHP
    • Cycle time and yield improvement initiatives
    • Continuous improvement projects
    • Regulatory audit preparation and follow-up
    • Cleaning (CIP/SIP) and sterilisation technologies
    • Component preparation – autoclaves and parts washers.
    • Primary container closure components
  • Specific knowledge of sterile pharmaceutical manufacturing processes and technologies. Ideally, aseptic filling operations.
  • Can lead multi-discipline teams through complex technical projects, while adhering to a set timeline.
  • Ability to co-ordinate projects, in addition to providing technical expertise, specifically:
    • Develop a project scope which includes an assessment of project impacts and required updates to other systems on site.
    • Preparing a schedule with multi-disciplinary input and maintaining that schedule through a project lifetime
    • Delegation of tasks to appropriate departments
    • Co-ordinate all project requirements such as material supplies and identification and management of third-party contractors
    • Handover of project to relevant department with awareness training if required.
    • Ensuring project needs are met from start to finish.
  • Strong technical knowledge of aseptic manufacturing techniques, procedures and theory.
  • Knowledge of best practices in pharmaceutical product development, scale-up and technology transfer.
  • Strong analytical skills, documentation skills and research skills.
  • Very strong problem-solving skills, ideally using formal tools e.g. FMEA.
  • Strong understanding of pharmaceutical industry regulatory requirements.
  • Clear understanding of the needs of cGMP and validation (DQ-PQ).
  • DoE knowledge desirable.
  • Knowledge of sterilization principles and practices
  • Strong communication and interpersonal skills.
  • Highly motivated with ability to work effectively with multidisciplinary teams or independently.
  • Can operate with low levels of supervision, with a proactive approach.
  • Strong team player.

Please note, we do not require agency assistance with this role.


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Role Details:

Job Title: Senior Process Engineer
Location: Westmeath
Type: Contract
Date: April, 2024
Image of recruitment specialist

Discuss with:

Lewis Murray
recruitment@prochem.ie
Recruitment Specialist
on +353 56 779 0100
Share:

Role Details:

Job Title: Senior Process Engineer
Location: Westmeath
Type: Contract
Date: April, 2024
Image of recruitment specialist

Discuss with:

Lewis Murray

recruitment@prochem.ie

Recruitment Specialist

on +353 56 779 0100

Share:

Role Summary:

  • A new vacancy for an experienced Process Engineer exists on our clients site based in Co. Westmeath.
  • The Process Engineer is responsible for the operation of the process equipment on site.
  • The successful candidate will provide technical leadership in the areas of yield improvement, reliability, process control, manufacturing support, manufacturing process troubleshooting and product transfer.
  • The Process Engineer will report to the Senior Manager Technical Services.

Core Duties and Responsibilities:

  • Has ownership of process equipment line reliability. Ensuring that any process equipment related plant downtime is quickly and reliably resolved in a cGMP compliant manner. Identify the short, medium and/ or long-term fixes for the downtime and manages the implementation of these fixes.
  • Pro-actively identify risks to the security of site manufacturing supply. Lead cross functional teams in projects to mitigate these risks.
  • Works with manufacturing and quality colleagues as part of an Operations team whose shared goal is to realise the safety, quality, delivery and cost objectives of the site.
  • Prioritises safety and is diligent in the use of all appropriate safety tools and permits when maintaining equipment – champions safe working always.
  • Is the process SME for the products, supporting or leading product related deviations, change controls and CAPAs.
  • Supports manufacturing by leading/supporting deviation investigations and is familiar with structured problem solving and root cause analysis.
  • Supports validation activity in process manufacturing areas.
  • Leads continuous improvement projects and initiatives and is owner of yield performance, cycle time improvement and capacity increase.
  • Provides technical support for product APRs (Annual Product Review)
  • Provides training and mentoring to build technical capabilities among teams.
  • Supports capital projects throughout equipment lifecycle.
  • The role will typically require infrequent, off-site national and international travel, for business or equipment/project review meetings, including overnight stays, up to 10% of the time.

Minimum Qualifications and Experience:

  • Bachelors Degree in Engineering, Pharmaceutical Sciences, or related Science discipline; further qualification (Masters) in related discipline ideal.
  • At least 5 years relevant experience in a pharmaceutical manufacturing environment, with at least 3 years experience in a comparable process engineering/technical services role.
  • Must have experience working in a sterile manufacturing environment.
  • Ophthalmic manufacturing experience a plus.
  • Experience with many of the following processes:
    • Vial or bottle filling of sterile solutions
    • Compounding – dispensing, formulation, sterile filtration, etc.
    • Isolator technology incl. VHP
    • Cycle time and yield improvement initiatives
    • Continuous improvement projects
    • Regulatory audit preparation and follow-up
    • Cleaning (CIP/SIP) and sterilisation technologies
    • Component preparation – autoclaves and parts washers.
    • Primary container closure components
  • Specific knowledge of sterile pharmaceutical manufacturing processes and technologies. Ideally, aseptic filling operations.
  • Can lead multi-discipline teams through complex technical projects, while adhering to a set timeline.
  • Ability to co-ordinate projects, in addition to providing technical expertise, specifically:
    • Develop a project scope which includes an assessment of project impacts and required updates to other systems on site.
    • Preparing a schedule with multi-disciplinary input and maintaining that schedule through a project lifetime
    • Delegation of tasks to appropriate departments
    • Co-ordinate all project requirements such as material supplies and identification and management of third-party contractors
    • Handover of project to relevant department with awareness training if required.
    • Ensuring project needs are met from start to finish.
  • Strong technical knowledge of aseptic manufacturing techniques, procedures and theory.
  • Knowledge of best practices in pharmaceutical product development, scale-up and technology transfer.
  • Strong analytical skills, documentation skills and research skills.
  • Very strong problem-solving skills, ideally using formal tools e.g. FMEA.
  • Strong understanding of pharmaceutical industry regulatory requirements.
  • Clear understanding of the needs of cGMP and validation (DQ-PQ).
  • DoE knowledge desirable.
  • Knowledge of sterilization principles and practices
  • Strong communication and interpersonal skills.
  • Highly motivated with ability to work effectively with multidisciplinary teams or independently.
  • Can operate with low levels of supervision, with a proactive approach.
  • Strong team player.

Please note, we do not require agency assistance with this role.

Image of recruitment specialist

Discuss with:

Lewis Murray
recruitment@prochem.ie
Recruitment Specialist
on +353 56 779 0100
Share:

Apply Now

"*" indicates required fields

Full Name*
Accepted file types: pdf, docx, odt, doc, txt, Max. file size: 32 MB.
Accepted file types: pdf, docx, odt, doc, txt, Max. file size: 32 MB.
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