Role Summary:

  • A fantastic opportunity has arisen for a Senior Process Engineer to join our client’s Pharmaceutical Site in Co. Waterford.
  • The successful candidate will provide process engineering support and project leadership to support internal customers in the day-to-day operations of the organization and site capital projects, enabling delivery of high quality process centered projects safely, on time and within budget.
  • Reporting to Engineering & Facilities Manager.

Core Duties and Responsibilities:

Health & Safety

  • Comply at all times with the Health, Safety and Environmental policy and associated procedures, legislative requirements.
  • Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do.
  • Ensure safety management is paramount in project delivery processes
  • Lead by example and take ownership of EHS matters in relation to engineering activities you are involved in.

Quality Compliance

  • Ensure all work carried out is in compliance with the required standards, conforming to company policy, cGMP, SOP and regulatory guidelines.
  • Lead by example and take ownership for quality compliance in relation to engineering activities you are involved in.
  • Ownership of equipment qualification and process validation from a quality compliance perspective.

Process Engineering

  • Identify and manage process improvements and projects
  • Lead in the procurement, introduction, commissioning and qualification of process equipment and subsequent process validations
  • Ensure qualification methodology is clear and integrated into the project from URS onwards
  • Ensure documentation, training and handover meet the internal customers’ expectations
  • Life cycle cost considered in designs for maximum long term efficiency and reliability
  • Plan and execute process validation schedules for manufacturing and packaging processes.
  • Write and execute documents for the validation of new and existing processes.
  • Liaise with contractors/customers when external resources are required to complete validations.
  • Liaise with relevant departments to organise resources/materials/ equipment/facilities/etc and ensure validation activities are planned and executed in line with applicable deadlines.
  • Assist with submission/audit/deficiency responses activities when required, in a timely manner.
  • Draft/revise/review validation related documents e.g. SOPs, protocols, reports etc.
  • Generate, analyse and interpret statistical data to verify acceptable criteria has been met and support process validations, CPVs
  • Develop testing strategies and rationale for manufacturing and packaging process equipment qualification and process validation.
  • Provide technical support/troubleshooting for process and equipment issues.
  • Investigate/resolve deviations associated with validation activities.
  • Utilise structured problem solving in support of process issues & problem resolution.

Contractor Coordination

  • Ensure contractors are budgeted, approved, scheduled, qualified and permitted for the work they perform under your behest.
  • Develop relationships with contractors, ensure they understand our business and are compliant to site procedures.

Reporting and Governance

  • Report covering schedule, cost control, project scope and risks / mitigations, compiled at appropriate intervals.
  • All project and equipment related information stored centrally
  • Ensure clear, concise communications with internal & external stakeholders.

Minimum Qualifications and Experience:

  • Qualified to a minimum of degree level in an Engineering discipline
  • 5+ years’ engineering experience working in an oral solid dose pharmaceutical manufacturing and/or packaging (or comparable) environment
  • Process validation (including statistics training) experience is an advantage
  • Knowledge of processes and equipment used in manufacturing and packaging of tablets and capsules
  • Management of small capital projects
  • Problem solving
  • Integrating in and leading cross functional teams
  • Knowledge of cGMP, EU Annex and GAMP requirements
  • Understanding of integrated validation approaches
  • Minitab or similar statistics software is an advantage
  • Scheduling
  • Ability to manage multiple conflicting demands and to prioritise accordingly
  • Focus on supporting internal & external customers in a safe and compliant manner
  • Motivating others positively
  • Ability to work independently and in teams
  • Natural influencer
  • Be driven by task / project and will show flexibility to ensure results are achieved
  • Thinking ‘outside the box’
  • Self-starter and accustomed to setting personal goals

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


Apply Now

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Role Details:

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

Discuss with:

Ruth Holland
recruitment@prochem.ie
Recruitment Specialist
on +353 56 779 0100
Share:

Role Details:

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

Discuss with:

Ruth Holland

recruitment@prochem.ie

Recruitment Specialist

on +353 56 779 0100

Share:

Role Summary:

  • A fantastic opportunity has arisen for a Senior Process Engineer to join our client’s Pharmaceutical Site in Co. Waterford.
  • The successful candidate will provide process engineering support and project leadership to support internal customers in the day-to-day operations of the organization and site capital projects, enabling delivery of high quality process centered projects safely, on time and within budget.
  • Reporting to Engineering & Facilities Manager.

Core Duties and Responsibilities:

Health & Safety

  • Comply at all times with the Health, Safety and Environmental policy and associated procedures, legislative requirements.
  • Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do.
  • Ensure safety management is paramount in project delivery processes
  • Lead by example and take ownership of EHS matters in relation to engineering activities you are involved in.

Quality Compliance

  • Ensure all work carried out is in compliance with the required standards, conforming to company policy, cGMP, SOP and regulatory guidelines.
  • Lead by example and take ownership for quality compliance in relation to engineering activities you are involved in.
  • Ownership of equipment qualification and process validation from a quality compliance perspective.

Process Engineering

  • Identify and manage process improvements and projects
  • Lead in the procurement, introduction, commissioning and qualification of process equipment and subsequent process validations
  • Ensure qualification methodology is clear and integrated into the project from URS onwards
  • Ensure documentation, training and handover meet the internal customers’ expectations
  • Life cycle cost considered in designs for maximum long term efficiency and reliability
  • Plan and execute process validation schedules for manufacturing and packaging processes.
  • Write and execute documents for the validation of new and existing processes.
  • Liaise with contractors/customers when external resources are required to complete validations.
  • Liaise with relevant departments to organise resources/materials/ equipment/facilities/etc and ensure validation activities are planned and executed in line with applicable deadlines.
  • Assist with submission/audit/deficiency responses activities when required, in a timely manner.
  • Draft/revise/review validation related documents e.g. SOPs, protocols, reports etc.
  • Generate, analyse and interpret statistical data to verify acceptable criteria has been met and support process validations, CPVs
  • Develop testing strategies and rationale for manufacturing and packaging process equipment qualification and process validation.
  • Provide technical support/troubleshooting for process and equipment issues.
  • Investigate/resolve deviations associated with validation activities.
  • Utilise structured problem solving in support of process issues & problem resolution.

Contractor Coordination

  • Ensure contractors are budgeted, approved, scheduled, qualified and permitted for the work they perform under your behest.
  • Develop relationships with contractors, ensure they understand our business and are compliant to site procedures.

Reporting and Governance

  • Report covering schedule, cost control, project scope and risks / mitigations, compiled at appropriate intervals.
  • All project and equipment related information stored centrally
  • Ensure clear, concise communications with internal & external stakeholders.

Minimum Qualifications and Experience:

  • Qualified to a minimum of degree level in an Engineering discipline
  • 5+ years’ engineering experience working in an oral solid dose pharmaceutical manufacturing and/or packaging (or comparable) environment
  • Process validation (including statistics training) experience is an advantage
  • Knowledge of processes and equipment used in manufacturing and packaging of tablets and capsules
  • Management of small capital projects
  • Problem solving
  • Integrating in and leading cross functional teams
  • Knowledge of cGMP, EU Annex and GAMP requirements
  • Understanding of integrated validation approaches
  • Minitab or similar statistics software is an advantage
  • Scheduling
  • Ability to manage multiple conflicting demands and to prioritise accordingly
  • Focus on supporting internal & external customers in a safe and compliant manner
  • Motivating others positively
  • Ability to work independently and in teams
  • Natural influencer
  • Be driven by task / project and will show flexibility to ensure results are achieved
  • Thinking ‘outside the box’
  • Self-starter and accustomed to setting personal goals

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

Image of recruitment specialist

Discuss with:

Ruth Holland
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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