Commissioning and Qualification Engineer (m/f/d)
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Boudry, Schweiz |
Temporary Employment
Job title: Commissioning and Qualification Engineer (m/f/d)
Industry: PharmaSkills: Engineering,CQV
Start of project: 01.04.2024
Duration of the project : 6 months
Project volume: 960 Hour(s)
Location: Boudry, Schweiz
Tasks:
- The C&Q Engineer will provide oversight of the site commissioning and qualification organization in support of capital projects.
- The individual oversees the C&Q work activities to ensure on time and within budget completion.
- Responsible for driving the commissioning and qualification activities at Boudry (incl. Utilities, equipment, CSV) according to site and global SOPs, and regulatory requirements.
- Lead a team of colleagues and/or contractors to achieve C&Q objectives aligned with capital project milestones and site goals.
- Effectively manages assigned resources to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies.
- Interface with site and global functions (Engineering, Technical Services, MS&T, end user groups, QA, suppliers, Architectural / Engineering Contractor, Construction Management contractor, Asset Care Management contractor, and C&Q contractor)
- Design and author the validation/qualification approach (plan), provide the scientific rationale and acceptance criteria, generate and review/approve commissioning, validation/qualification protocols/reports.
- Conduct, and assist others, in industry and regulatory research including research into industry standards/FDA guidelines for validation equipment / processes and make determinations regarding acceptance criteria and testing.
- Support project team, coordinate the execution of C&Q of the project, prepare project schedules and provide presentations to stakeholders on project status.
- Support the completion of complex investigations, initiate change controls (incl. assessing impact of the change) and managing corrective action plans associated with C&Q activities.
- Support the implementation of structures, tools, and processes to actively manage C&Q activities.
- Participate when required during internal and external audits for which he is a SME, by answering questions, reviewing qualifications and validations with auditors, and providing documentation.
Qualifications:
- Degree in Engineering or Science related discipline performed (i.e. life science, Mechanical, Chemical degree).
- 5-10 years of relevant pharmaceutical industry experience (with a focus on OSD pharmaceutical application validation in a GMP environment).
- 5-10 years’ experience in managing personnel and/or complex projects, including direct experience in managing different Commissioning/Qualification/Validation contractors and activities for large and complex projects.
- Problem-solving skills, verbal and written communication skills.
- Ability to work independently and to influence and work across organizational boundaries.
- Must have interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.
- Excellent command of English and preferably French language.
- Project and change management experience. Experience with Product Life Cycle Management.
- Experienced in Health Authority inspections (preparation, process, presentations, responses drafting, etc.) with direct interactions including face to face interaction and response to audit questions.
Reference number: 14296
Industry: Pharma
Project start: 01.04.2024
Duration: 6 months
Employment type: Temporary Employment
Contact
Michael Richardson