Validation Project Engineer mfd

Our 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 companys role is crucial in supporting developing and maintaining highquality 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 highquality 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.
Develop coordinate manage and control projects and project teams and ensure the proper execution of their part of the companys 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 groups 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 Qualityoriented 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/qualityoriented 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 holders 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 industryspecific 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
375h 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 6month 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 clients mission to deliver cuttingedge solutions offers a sense of purpose and fulfillment knowing that ones 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.