C&Q Engineer

Proclinical is seeking a dedicated and innovative Commissioning and Qualification (C&Q) Engineer to join our dynamic team. This role is an excellent opportunity for someone passionate about making a significant impact within the Life Science industry. The C&Q Engineer will be a key player in implementing packaging projects and ensuring successful collaboration with the project team.

Responsibilities:

• Collaborate with the project team and site validation teams to direct the implementation of packaging projects.
• Execute required steps within the project management process.
• Develop and update the C&Q project schedule, particularly during the construction and C&Q phases.
• Provide oversight of the site commissioning and qualification organisation in support of capital projects.
• Lead and manage a team focused on commissioning and qualifying facilities, utilities, process equipment, and Computerised System.
• Drive the commissioning and qualification activities at Boudry according to standards, site and global SOPs, and regulatory requirements.
• Coordinate approval of the deliverables as defined in the project's C&Q plan.
• Interface with site and global functions to accomplish predefined goals and provide technical guidance.
• Design and author the validation/qualification approach, provide the scientific rationale and acceptance criteria, generate and review/approve commissioning, validation/qualification protocols/reports.
• 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 and manage corrective action plans associated with C&Q activities.
• Participate when required during internal and external audits, answering questions, reviewing qualifications and validations with auditors, and providing documentation.

Key Skills and Requirements:

• Degree in Engineering or Science related discipline (i.e., life science, Mechanical, Chemical degree).
• Relevant pharmaceutical industry experience, with a focus on OSD pharmaceutical application validation in a GMP environment.
• 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.
• Excellent problem-solving skills, verbal and written communication skills.
• Ability to work independently and to influence and work across organisational boundaries.
• Team player with a willingness 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.

If you are having difficulty in applying or if you have any questions, please contact Chloe Jack at c.jack@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.