AdresseOur client, founded in 2002, is seeking a Validation & Project Engineer (m/f/d) for its newly founded branch in Germany. The company specializes in biotechnology and pharmaceutical manufacturing, providing engineering solutions and consultancy services. 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 in the pharmaceutical or related industries. 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.
Tasks
• Deliver and support Validation, Quality, and Regulatory projects, typically up to a value of EUR 1,500,000.
• Develop, coordinate, manage, and control projects and project teams, and ensure the proper execution of their part of the company's business, emphasizing efficiency and contractual, legal, safety, quality, cost, and time compliance in projects and in the project process.
• Implement and maintain suitable project procedures, controls, and records by prevailing good practice and Company QA procedures, including, but not necessarily limited to, where related to contract, scope, health & safety, programme, cost, quality, risk, value, procurement, configuration & change control, communications, roles & responsibilities, disputes, project finances, completion, etc.
• Act as project interface between the company and others. Coordinate the project and communication process internally and between the company and others, including, but not necessarily limited to, suppliers, contractors, clients, statutory bodies, the public, and other third parties.
• Ensure that prevailing good practice and the project and Company QA systems are the basis of all project work. Assist in Quality Audits of the project team and its work.
• Maintain detailed deliverables requirements on projects, including scheduling the necessary resource allocation to produce the required deliverables within the scope, safety, cost, programme, and quality parameters of the prevailing contract.
• Keep resource planning tools updated with the project(s) being managed.
• Manage resources to produce the required project deliverables, including the ongoing monitoring and reporting of resource usage, earned value, compliance, and other requirements. Implement appropriate actions to address variances.
• Provide suitable project reports regularly to the company and attend regular project reviews with company management.
• Hold and record regular project progress reviews with the project team. Provide appropriate information to management to enable effective reporting and to enable variances to be addressed.
• Actively pursue ongoing improvement in quality, efficiency, innovation, etc., within projects and the project team.
• Provide input to developing new business through industry/client leads and generating project proposals and submissions in line with the QCS group's business plan and financial goals and targets. Ensure that project deliverables, related quality, and resource requirements are suitably defined within such submissions.
• Undertake other roles necessary within a project context, such as consultancy support. For example, provide Audit support or input into design and build projects.
• Undertake suitable and sufficient Continuing Professional Development (CPD) to ensure competency by the standards reasonably required of the role, maintain adequate records, and provide such records to the company.
• Arrange and conduct the assessment and training in quality and other project matters to ensure that the project team and all its members are competent and effective. Provide mentoring, development, support, and feedback to the project team. Supervise and support the development of junior resources on projects.
• Maintain positive, constructive, honest, and appropriate relationships with the company, its personnel, supply chain, associates, clients, and others.
Technical competencies:
• Experience in program management associated with developing documentation, execution, summary documents, and Standard Operations Procedure.
• Working knowledge and practical experience in managing Regulatory and Quality-oriented projects, from the development of documentation to execution activities and report development.
• Experience in project planning, typically utilizing packages such as MS Project to define project baselines to monitor, control effectively, and forecast project resource requirements and costs.
• Able to successfully develop and lead project teams to deliver objectives. To progress, monitor, and report on the execution of multiple regulatory/quality-oriented tasks on a routine basis.
• Provide subject matter expertise within the organization and in the delivery of client projects. The nature of knowledge is likely to be project management or related to the holder's technical qualifications and background.
• Strong organizational, communication, and management skills with clients, colleagues, supply chain, and third parties.
Requirements
• 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.
Benefits
Your offer:
• 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
Your advantages:
• 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.
