Commissioning, Qualification And Validation Manager [F/M/X]

at  Amaris

Job description
Employment Type: Part-Time (Up to 20 hours/week)
Mission Description: We are seeking a highly skilled and experienced Commissioning and Qualification (CQV) Manager to lead our commissioning and qualification program. The ideal candidate will have a strong background in engineering within a cGMP environment and will be responsible for ensuring compliance and efficiency in our CQV processes.

REQUIREMENTS:

Degree in Biotechnology, Chemical Engineering, Bioengineering, Life Sciences, or related fields.
Minimum of 10 years of experience in an engineering role within a cGMP environment, with at least 5 years in a people management role.
Highly adaptable and capable of performing in a dynamic working environment.
Knowledge of the Validation Lifecycle Approach and familiarity with risk-based validation approaches.
Experience in facility design, qualification, and startup.
Ability to read and interpret engineering drawings and design documents.
Strong technical writing skills, with the ability to create SOPs and review relevant ISPE/PDA, cGMP guidelines, and technical documents.
Self-starter, self-motivated, and task-oriented, with the ability to motivate teams to ensure timely completion of deliverables.
Excellent interpersonal skills to build relationships and foster a sense of team purpose and achievement.
Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.
Who are we?
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7500 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.
At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here’s what our recruitment process looks like:
Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate’s shoes to ensure they have the best possible experience.
We look forward to meeting you

Overall accountability for the commissioning and qualification program, including commissioning & qualification, computerized system validation, and thermal validation.
Perform strategic planning and development of activities for the company’s CQV function, focusing on compliance, capacity, timelines, and directions.
Collaborate closely with the senior project leadership team to ensure successful project execution.
Manage CQV projects of various sizes, providing technical assistance and ensuring the commissioning/validation of GMP facilities.
Act as a subject matter expert and resource for peers and colleagues.
Develop CQV Plans for validation projects and oversee contract staff as necessary, including the development of statements of work and vendor selection.
Write, review, and approve associated commissioning, qualification, and validation protocols and reports, ensuring appropriate resolution of protocol exceptions.
Develop work plans, assign tasks, and lead teams to achieve project goals.