C&Q Engineer

1 month ago

Cork, Ireland PSC Biotech Ltd Full time
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. 

Description:   Commissioning & Qualification (C&Q) Engineer.

Summary & Purpose:

The role of the C&Q Engineer and associated activities include (but not limited to), the preparation and execution of commissioning and qualification protocols (where applicable) for site systems / equipment such as Reactors, Centrifuges, Dryers, Powder Handling Units, Skids, Vessels, Tanks, Pumps, Laminar Airflow Booths, autoclaves and isolators and clean / gray utility systems (such as purified water, water for injection clean steam, HVAC, Process Gases, Steam and Condensate systems etc.).

Job Responsibilities:

  • Provide input into all aspects of C&Q i.e. from design through to commissioning and qualification completion.
  • Support and participate in the design of systems and equipment to ensure they comply with cGMP requirements.
  • Prepare C&Q protocols as required (e.g. URS’s / SRS’s, Plans, Impact Assessments, DQ, IQ, OQ, PQ protocols and Reports).
  • Review and approve documents prepared by contractor organisations (e.g. vendor SAT’s, FAT’s, commissioning protocols, project change controls/notifications).
  • Execute C&Q protocols as required.
  • Compile relevant documentation from vendors, contractors, and other departments for inclusion in protocols / reports.
  • Complete activities / deliverables in accordance with each project’s site change control required deliverables (from a C&Q perspective).
  • Track and support the resolution of Commissioning punch list items and Qualification deviations during the C&Q execution phase.
  • Prioritize C&Q activities in line with site and project schedules.
  • Co-ordinate C&Q activities with project engineering, construction and site operations activities.
  • Co-ordinate C&Q activities with contractors and vendors as required.
  • Co-ordinate C&Q document reviews and approvals.
  • C&Q System / Equipment / Components as per site procedures.
  • Strong collaboration with Quality Department.

Experience: 

  • Minimum 5+ years’ experience in the Pharmaceutical (API) Industry.
  • Experience of commissioning and qualifying some of the following systems:
    Reactors, Centrifuges, Dryers, Powder Handling Units, Skids, Vessels, Tanks, Pumps, Laminar Airflow Booths, autoclaves and isolators and clean / gray utility systems (such as purified water, water for injection clean steam, HVAC, Process Gases, Steam and Condensate systems etc.).
  • Experience preparing and executing commissioning and qualification protocols and reports.
  • Knowledge and experience of Project Delivery Processes (PDP).
  • Knowledge and experience of current Good Engineering Practices (GEP).

Following would be an advantage,
  • Experience with use of ABB Industrial IT control systems.
  • Experience of Pharmaceutical facility local and controlling instrumentation


Requirements
Qualifications and Experience

Third level degree and relevant experience.
Required Knowledge, Skills and Abilities:

o Knowledge of GMP guidelines and regulation Q7A, etc.
o Experience in cGMP regulated environment.
o Extensive experience of commissioning and qualification of production systems, utilities and facilities and change management.
o Effectively partners and delivers results in a matrix environment; works collaboratively across site functions.
o Strong communication and interpersonal skills, ability to influence/impact.
o Excellent knowledge of English, both verbally and written.
o High degree of competency and experience of Microsoft Office suite, Word, Excel, Outlook etc.

Desirable:

o Experience of working within a Technical Compliance / Project team in a multinational corporate environment.
o Experience of ASTM 2500 and/or Risk Based Qualification approach.

Key Competencies Required

o Ability to operate as part of a team is critical.
o Excellent interpersonal skills.
o Customer focus.
o Innovative.
o Technical aptitude.
o Excellent communication skills both written and verbal.
o Attention to detail.
o Good problem-solving skills.
o Results and performance driven.
o Adaptable and flexible.

Significant Environmental, Health & Safety Considerations
  • All resources are required to comply with the requirements of the company’s Environmental, Health & Safety Policy, Safety Statement, associated EHS Procedures, local legislation and duties outlined in the site’s EHS Manual. In line with the Safety Health & Welfare at Work Act, all resources are required to:
o Take reasonable care to protect his or her own and the safety of their colleagues who may be affected by their actions.
o Compliance with EHS rules and procedures at all times.
o Understand the potential EHS impact of their activities.
o Attend and participate in EHS training as required.
o Use PPE and safety equipment as required.
o Report all incidents, accidents, and near miss events.

#LI-MC1

Requirements
Knowledge/Skills: Strong Project Management and organizational skills, including ability to follow assignments through to completion. Excellent verbal and written communication skills: Strong Technical writing skills for GMP documentation (e.g., investigations, procedures, change controls) and good Presentation skills. Escalate issues professionally and in a timely manner. Ensures compliance within regulatory environment. Demonstrated ability to work independently and deliver right first-time results under minimal direction. Experience participating in and leading cross-functional teams. Experience in managing multiple, competing priorities in a fast-paced environment. Relevant Experience: Bachelor’s degree in a Science or Engineering discipline. 3+ years of experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or health care organization. Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products an advantage. #LI-XA1

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