Day Process Engineer

1 month ago

Cork, Ireland PSC Biotech Full time
  • Industry Pharma/Biotech/Clinical Research
  • Work Experience 4-5 years
  • City Cork
  • State/Province Cork
  • Country Ireland
Job Description

About PSC Biotech

Who we are?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Day Process Engineer

Overview:

The Day Process Engineer is the Equipment SME for theprocess equipment within the Vaccine IPT(s)

The Process Engineer will be responsible for providingengineering support to the Vaccine IPT(s) in relation to the process equipment.This includes trouble shooting, investigating and documenting process equipmentissues that may have arisen on shift. The Day Process engineer will own allQuality and Safety investigations handed over from the shift. They will alsoown any resulting CAPAs relating to process equipment.

They will identify and assist in the implement equipmentprocess improvements and optimization opportunities.

Requirements

Requirements:

· Process optimization: continually evaluate andoptimize manufacturing processes to enhance efficiency, reduce waste, andminimize costs. Analyze data, collaborate with cross-functional teams, andidentify areas for improvement to achieve operational excellence.

· Troubleshooting and problem-solving: Play acritical role in identifying and resolving issues in manufacturing processes.Analyze data, conduct root cause analysis, and develop and implement solutionsto improve process performance and resolve bottlenecks.

· Process documentation: Responsible for creatingand maintaining maintenance plans on SAP, and engineering standard operatingprocedures (SOPs), work instructions, and process flow diagrams.

· Continuous improvement:actively participate in continuousimprovement initiatives and lean manufacturing practices. Collaborate withcross-functional teams to implement process improvements, such as implementingautomation, reducing cycle times, and enhancing product quality.

· Quality control: work closely with quality teamsto ensure that manufacturing processes comply with quality standards andregulations. QN and CAPA owner. Conduct audits with the quality team toidentify opportunities for improvement.

· Project management: Lead or participate inprojects related to process improvement, new product introduction, costreduction, or capacity expansion. Coordinate project activities, set timelines,allocate resources, and ensure successful project implementation.

· EHS: Works closely with the EHS teams to ensureEHS compliance. Completes EHS investigation, CAPA owner and is Standard Ownerfor SN25 Hot Work.

· Identify opportunities for process improvements,cost reductions, and energy efficiency enhancements related to mechanicalsystems and equipment.

Coaching and Training:

· Develop an effective, focused, and strong teamby understanding: their abilities and unique contribution.Provide your team with the tools anddevelopment opportunities to make them successful.

Key Behaviours:

Focus on Customers, Including Patients

· Focus the team on delivering value forcustomers, including patients, by understanding and meeting their needs.

· Actively listen and seek to understand differingperspectives from project team members; work together to achieve the commongoals of the company.

Act with Candor and Courage

· Speak openly, honestly and with conviction; havethe courage to take appropriate risks and make difficult decisions.

· Make Rapid, Disciplined Decisions

· Make timely decisions at the right level withthe right data, document decisions and support them once made.

Drive Results

· Set clear performance standards; overcomeobstacles; hold ourselves and others accountable for achieving results.

Demonstrate Ethics & Integrity

· Adhere to the highest standards of trustworthyand ethical behaviour in all interactions and hold others to the samestandards; comply with all laws, policies and regulations; identify and addressethical issues without hesitation.

· Build Talent: Build diverse talent with thecapabilities necessary to succeed in commercial vaccine manufacture; inspire,reward and develop to ensure individuals reach their potential; make toughcalls when necessary.

Experience:

· Demonstrated knowledge in more than onepharmaceutical and/or chemical manufacturing operation (e.g. manufacturing,quality, engineering, etc).

· At least 10 years’ experience in thePharmaceutical industry or a similar operating environment which includessignificant leadership roles with experience in a front-line supervisory rolein an operations environment.

· Knowledge of and experience in applying SixSigma and Lean methodologies.

· Demonstrated leadership and change managementskills with a continuous improvement focus.

Skillset:

· Proven track record of delivering highperformance against a balanced scorecard through development and coaching of ateam.

· Demonstrated ability to fully realize change andimprovement initiatives.

· Demonstrated ability in holding team membersaccountable for results and managing performance.

· Demonstrated leadership behaviours (refer toMerck key behaviours).

· Experience of moulding a culture to one ofinclusion and continuous development for all employees.

· Stakeholder management of multiple decisionmakers, corporate colleagues, cross-functional team by demonstrating theability to maintain and strengthen trust relationships with people on alllevels.

· Process and technology background: thesuccessful candidate will fully understand how to drive process optimisation.

Qualification:

· Degree or 3rd level qualification (Science,Engineering).Masters preferred.

· Desirable evidence of Continuous ProfessionalDevelopment.

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