Validation & Project Engineer (m/f/d)
Our client, founded in 2002, is seeking a Validation & Project Engineer (m/f/d) for its newly founded branch in Germany. The company provides engineering solutions and consultancy services in the biotechnology and pharmaceutical manufacturing,. It offers expertise in designing, engineering, and constructing facilities and provides technical support for pharmaceutical and biotech operations. Their services ensure that clients' facilities and processes comply with industry standards and regulatory requirements. This company's role is crucial in supporting developing and maintaining high-quality, efficient, and compliant manufacturing environments in the biotechnology and pharmaceutical fields.
The Validation & Project Engineer is responsible for delivering and supporting projects related to Validation, Quality, and Regulatory aspects. Reporting directly to the Managing Director, the engineer interacts with various internal and external stakeholders, including Directors, Line Managers, Staff, Clients, Contractors, and External Contacts. The role ensures that projects meet industry standards and regulatory requirements, thereby maintaining the high-quality output expected in such sensitive fields. The position requires combining technical expertise and project management skills, emphasizing strong communication and collaboration with diverse groups.
What will be your key responsibilities:
- Delivering and supporting Validation, Quality, and Regulatory projects up to EUR 1,500,000.
- Developing and managing projects and teams, ensuring efficient execution with compliance in safety, quality, cost, and time.
- Implementing and maintaining project procedures and records in line with Company QA procedures, covering areas such as contract, health & safety, program, cost, risk, procurement, and change control.
- Serving as the project interface, coordinating internal and external communication, including with suppliers, clients, and statutory bodies.
- Ensuring projects adhere to good practice and Company QA systems; assisting in Quality Audits.
- Maintaining detailed project deliverables, scheduling resources, and adhering to safety, cost, quality, and contractual parameters.
- Updating resource planning tools and managing resources for project deliverables, monitoring resource usage and compliance, and implementing corrective actions as needed.
- Regularly reporting on project progress to company management and conducting project reviews.
- Continuously improving quality and efficiency within projects.
- Contributing to new business development, preparing project proposals, and ensuring project deliverables meet quality and resource requirements.
- Undertaking consultancy roles, providing Audit support, and inputting into design and build projects.
- Maintaining CPD for role competency, record-keeping, and conducting quality and project training for team competency.
- Maintaining positive relationships with company personnel, clients, and other stakeholders.
- Technical competencies include program managing, managing Regulatory and Quality projects, experience in project planning with tools like MS Project, leading teams, providing subject matter expertise in project management, and strong organizational and communication skills.
What experience should you have:
- Educational Background: At least a Bachelor of Science (B.Sc.) or Bachelor of Arts (B.A.) degree in a scientific or related field.
- Experience in Quality/Regulatory Field: Several years of professional experience in the Quality/Regulatory field is required. You should have substantial experience and knowledge in quality assurance, quality control, regulatory compliance, and related areas. This experience is critical for ensuring that projects adhere to industry-specific quality standards and regulatory requirements.
- Project Management Experience:
Several years of experience in Project Management, specifically in a field related to Quality and Regulatory affairs. This experience should include managing project timelines, resources, and budgets and leading project teams.
- Being adept at coordinating multiple aspects of projects, from planning and execution to monitoring and final delivery, ensuring that projects are completed efficiently and effectively.
- Fluency in German as well as very good English skills.
- Willingness to travel approximately 25 %.
What do you get in return:
- Attractive total package
- 37,5h working week
- 30 off days per year; off days will increase to up to 35 days per year within the 1st two years at the company
- Indefinite working contract after 6-month probation period
- Car allowance and mileage allowance
- Pension allowance
- Work model: This role encompasses a hybrid approach, combining onsite work with client(s), remote work, and occasional meetings in Braunschweig.
- Leadership in a hub of innovation: Being part of a company expanding into Germany, a country known for its vibrant scientific community and innovative spirit, offers exciting leadership opportunities and the chance to be at the forefront of scientific progress.
- Global presence: The role provides an opportunity to contribute to a company with a growing global footprint, enhancing professional exposure and experience in the international arena.
- Impactful work in radiopharmaceutical manufacturing: Working with this expanding company involves contributing to groundbreaking advancements in the specialized and impactful field of radiopharmaceutical manufacturing.
- Opportunities for collaboration: The expansion fosters collaboration and partnership, allowing one to work with diverse teams and forge meaningful connections in the industry.
- Driving excellence in healthcare solutions: Being a part of our client's mission to deliver cutting-edge solutions offers a sense of purpose and fulfillment, knowing that one's work directly benefits patients and the broader healthcare community.
- Personal and professional growth: This role offers a unique personal and professional development platform in a dynamic and challenging environment.