Technical Project Lead
About the Role:
We are seeking a seasoned Technical Unit Manager with expertise in Commissioning, Qualification, and Validation (CQV) to lead complex projects from inception to completion. The ideal candidate will have a strong background in managing CQV projects independently, ensuring deliverables meet regulatory and client expectations.
Key Responsibilities:
* Project Leadership: Manage CQV projects, including analyzing technical requests, identifying risks, and defining project assumptions.
* Bid Management: Develop technical approaches, define deliverables, estimate workload, and manage bidding processes autonomously.
* Technical Expertise: Oversee commissioning, qualification, and validation activities, ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulations.
* Risk Assessment: Identify and mitigate risks associated with equipment, processes, and systems to ensure seamless project execution.
* Stakeholder Engagement: Collaborate with clients, project teams, and stakeholders to ensure alignment and satisfaction.
* Continuous Improvement: Stay updated on industry trends, regulatory requirements, and best practices to provide cutting-edge solutions.
Qualifications:
* Minimum of 5 years of experience in CQV within the pharmaceutical or life sciences sector.
* Proven expertise in managing CQV projects independently.
* Strong ability to manage bids autonomously.
* Excellent analytical skills to understand technical requests, identify risks, and define project assumptions.
* Deep understanding of regulatory requirements (e.g., GMP, FDA, EMA) and validation standards.
* Exceptional communication and interpersonal skills to effectively engage with clients and stakeholders.
* Bachelor's or Master's degree in engineering, life sciences, or a related field.
What We Offer:
* Competitive salary based on experience.
* Company car as part of the benefits package.
* Opportunities for career development in a dynamic and growing company.
* A collaborative and inclusive work environment.
Additional Information:
This is an exceptional opportunity for a skilled professional to take on new challenges and contribute to the success of our organization. If you are passionate about quality, have a strong background in validation, and are looking for a rewarding opportunity, we encourage you to apply.