Senior CQV Engineer

☞ PM Group

見る: 101

更新日: 01-06-2024

場所: Birmingham West Midlands

カテゴリー: ハイテク 機械/技術 電気/電子工学 IT-ソフトウェア

業界: Architecture & Planning

ジョブタイプ: Full-time

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仕事内容

Overview

You will be accountable for managing, coordinating and executing a full suite of Commissioning, Qualification & Verification (CQV) projects across the UK for our customers. The portfolio of projects will be diverse and varied in demand so you will require an adaptable and flexible approach towards delivery, including travel.

A rewarding and diverse opportunity where you will be part of a multi-disciplinary team and have the opportunity to handle and manage clients with autonomy. In addition to this, you will contribute to the internal standards, execution and capability of the wider UK departmental team, through support and mentoring others.

Responsibilities

  • Prepare and execute Commissioning & Qualification (C&Q) plans in line with the strategic goals of our customers.
  • To co-ordinate and align the activities of the plan aligned with client engineering, quality and production requirements.
  • To liaise with all departments necessary for delivery of the projects.
  • Close liaison is required between Design, Engineering, Procurement and Construction.
  • Develop and execute C&Q lifecycle Protocols.
  • Lead C&Q projects on behalf of the UK department as directed and appropriate.
  • Assist with alignment between the C&Q project teams and client expectations.
  • Assist and support with resource allocation, management and supervision.
  • Identify improvements in existing work methods to achieve best practice / be more competitive.
  • Liaise closely with UK Head of CQV, Group CQV and actively contribute to the CQV Community of Practice.
  • Ability and flexibility to travel.
  • Other reasonable duties as assigned.

Qualifications

  • Bachelor Degree or equivalent in related subject (e.g. Chemical Engineering) is preferred.
  • Hands-on experience of C&Q activities within a pharmaceutical environment, with an ability to translate client strategic goals in to practical plans for project C&Q activities.
  • Familiar with and conversant in Current GMP & Engineering Guidelines pertaining to UK/Europe/USA e.g. ICH, MHRA ‘Orange Guide’, ISPE, GAMP, CFR etc
  • Experienced in Qualification of:
  • Manufacturing Equipment
  • Utilities i.e. Highly Purified Water, Process Gasses
  • Facilities i.e. Cleanrooms, HVAC
  • Control Systems i.e. SCADA, DCS, PLC etc.
  • Be able to demonstrate ability to write and execute suitable documentation and Protocols including System Impact Assessments, URS, VMP, RTM, DQ, IQ, OQ and Validation Final Reporting.
  • Proven successful track record in FDA/MHRA Inspections preferable.
  • Experience in implementing C&Q policies and procedures.
  • Ability to play a positive role in multi-discipline teams, seeking to improve existing ways of working, by finding efficiencies in processes.
  • Possess a professional approach and demeanour with a strong ethical approach to safety, quality, environmental protection and business.
  • Organised and time management skills - ability to meet project deadlines.
  • Excellent communication skills and demonstrable ability to communicate effectively with clients and peers at all levels.
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締切: 16-07-2024

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