- Mentor, coach and develop your diverse team expertise in Validation, Compliance and Continuous Improvement.
- Develop and implement an end-to-end compliance strategy focusing on safety, quality, and regulatory requirements.
- Own and refine the Validation & Qualification strategy in collaboration with Engineering, Technical Quality Assurance (TQA), and Digital Transformation & Innovation (DTI) teams.
- Ensure engineering operations demonstrate compliance with Good Manufacturing Practices (GMP) and Good Engineering Practices (GEP).
- Lead the Engineering business resilience program, including risk management initiatives, to enhance operational efficiency and continuity.
- Drive Lean Transformation initiatives within the Engineering department to optimize processes and improve efficiency.
- Deploy scalable strategies for new safety, quality, compliance, and validation solutions in accordance with legislation and company policies.
- Lead and coordinate training and development plans for the Engineering team to improve skills and foster a culture of exploration and design thinking.
- Leverage expert knowledge in Validation, Compliance, and Lean Transformation to align priorities with business goals and global industrial trends.
- Influence key collaborators locally and globally to ensure alignment with compliance objectives and performance goals.
- Masters or Bachelor's degree in Engineering, Pharmaceutical Sciences, or related field.
- Extensive experience (8+ years) in validation, compliance, and engineering within the pharmaceutical / biotechnology industry or other GMP industry.
- In-depth knowledge of GMP regulations, quality systems, validation & Lean Manufacturing principles (IQ/OQ/PQ) and industry best practices.
- Proven track record of strategic leadership in driving compliance initiatives and process optimization.
- Strong communication, organizational change and stakeholder management skills.
- Demonstrated ability to set and achieve ambitious performance goals that drive individual and team success.
- Vast opportunities to learn and move up and across our global organization.
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.
- Focus on innovation by implementing Microsoft Copilot and other business automation solutions.
- Generous Total Rewards Plan comprising competitive salary, bonus structure, fixed 13th month, holiday allowance and a collective health insurance.
- Focus on vitality with an on-site gym, vitality program and a restaurant with healthy food.
- Flexible work arrangement with days in the office and days from home.
-
Compliance Engineer
2 dagen geleden
HVC Dordrecht, NederlandWat bieden wij?€ €6.259 bruto per maand · 40-urige werkweek · Aantrekkelijke secundaire arbeidsvoorwaarden. Denk hierbij aan een Persoonlijke Arbeidsvoorwaarden Budget van 13,64% (bestaande uit oa vakantiegeld en eindejaarsuitkering) en een goede pensioenregeling en prima reiskos ...
-
Compliance Engineer
1 week geleden
HVC Dordrecht, NederlandFiscaal voordelig een fiets, PC, tablet kopen en voordelig fitnessen (FiscFree); · ~ Minimaal een bachelor opleiding in een relevant vakgebied, zoals techniek, milieukunde, of een vergelijkbare studie. · Bereidheid om te leren en zich voortdurend te ontwikkelen binnen het vakge ...
-
Compliance engineer
6 dagen geleden
HVC Dordrecht, Nederland VoltijdCompliance engineer · Dordrecht · Fulltime · Geplaatst op 25 maart · toggle Wat bieden wij? · € €6.603 bruto per maand · 40-urige werkweek · Aantrekkelijke secundaire arbeidsvoorwaarden. Denk hierbij aan een Persoonlijke Arbeidsvoorwaarden Budget van 13,64% (bestaande uit o.a ...
-
Environmental Compliance Engineer
1 week geleden
Bureau Veritas Group Rotterdam, Nederland Onbepaalde tijdBen jij een gedreven professional met een passie voor milieuwetgeving en duurzaamheid? Bij Bureau Veritas Marine & Offshore in Rotterdam hebben we een uitdagende rol voor jou als Environmental Compliance Engineer. Je krijgt de kans om je te verdiepen in de nieuwste milieuvoorschr ...
-
Portfolio Manager
1 week geleden
SCANIA Breda, Nederland**Beschrijving**: · - For the growing activities of at Scania Financial Services within our Central European region, Scania is looking for a Portfoliomanager, Project management officer. · Scania is undergoing a transformation from being a supplier of trucks, buses and engines to ...
-
Product Compliance Engineer
3 dagen geleden
Supermicro 's-Hertogenbosch, NederlandSupermicro is seeking for an EMC compliance engineer with working knowledge of international standards governing telecommunication equipment (CE, BSMI, CCC, VCCI etc.) as well as experience working with UL, CSA, or other NRTLs to meet necessary compliance standards. The ideal can ...
-
Quality & Compliance Engineer (g/v/m)
1 week geleden
Uniper SE Rotterdam, NederlandUniper produceert elektriciteit, warmte en stoom in Nederland. In België leveren we deze producten ook aan zakelijke klanten. Onze centrales dragen bij aan de leveringszekerheid in Nederland. Daarnaast leveren wij ondersteunende diensten die helpen het hoogspanningsnet te balance ...
-
SW Engineer 3rd Party SW Compliance
3 dagen geleden
TEKsystems Veldhoven, NederlandThe software engineer is responsible for developing and embedding tools that support product- and software security risk management and compliance assessments. In this role you will work closely together with other software teams, risk and compliance specialists and a motivated o ...
-
Team Lead Outfitting
6 dagen geleden
Damen Naval Schiedam Schiedam, Nederland**ABOUT US**: · Get on board with Damen Naval, along with more than 1,200 professionals based in The Netherlands, Romania, and Germany. We are the naval division of the family-owned Damen Shipyards Group which employs 12,000 professionals globally. Damen Naval designs and builds ...
-
Installations Director Iref North West Europe
1 week geleden
Johnson Controls International Dordrecht, NederlandIn this role, you will have the opportunity to oversee and manage a large team of Installation Managers, typically spanning across Belgium, Netherlands, Denmark, Norway, Sweden, and Finland. Your primary responsibility will be leading the installation operations across North-West ...
-
Category Manager Mro
14 uur geleden
Delrin Dordrecht, Nederland**Delrin**** Job Description** · **Category Manager MRO & Capital - Global** · **Delrin**** Overview**: · The Category Manager for MRO & Capital is responsible for developing and implementing global category strategies for Maintenance, Repair, and Operations (MRO) and Capital exp ...
-
Structural Analyst
6 dagen geleden
Damen Naval Schiedam Schiedam, Nederland**ABOUT US**: · Get on board with Damen Naval, along with more than 1,200 professionals based in The Netherlands, Romania, and Germany. We are the naval division of the family-owned Damen Shipyards Group which employs 12,000 professionals globally. Damen Naval designs and builds ...
-
Legal and Compliance Internship: Project Management
1 dag geleden
ASML Veldhoven, Nederland StageSHIP**Introduction**: · Are you a bachelor or master student in Communications, Project Management or something related? Do you have an interest in the Legal domain? Then this internship could be interesting for you · **Background information**: · The ASML Legal Operations and Strate ...
-
Head of Legal
2 dagen geleden
ASML Veldhoven, Nederland**_Head of Legal - Corporate & ESG (Director) _** · **Introduction to the job** · We believe digital transformation holds the key to a better future. Without microchips, there would be no smartphones, internet or modern aviation to connect us. There would be no satellites to bett ...
-
Emc Competence Lead
4 dagen geleden
ASML Veldhoven, Nederland**Introduction to the job** · Are you challenged by the engineering of electronic solutions for high-tech products? And do you have excellent communication skills, combined with a high level of discipline? You'd better contact us today · **Role and responsibilities** · As EMC Com ...
-
Cost Controller
3 dagen geleden
Crane CP&E - Dovianus BV Bergschenhoek, Nederland**KEY RESPONSIBILITIES** · - Manage Month end close procedure · - Manage and prepare the accurate compilation of management reports · - Manage yearly plan, quarterly forecast and weekly pulse process · - Manage and assist with statutory and internal audits · - Ensure management c ...
-
Hse Manager
1 week geleden
Impes Service SpA Rotterdam, NederlandThe HSE Manager reports to the Company Health & Safety Manager (RSPP). · - Summary of Safety Coordinator's role and duties by activities:_ · **Advising** · - In issues related with design, planning, construction and maintenance; · - In issues related with the introduction of new ...
-
Product Security Expert
1 dag geleden
ASML Veldhoven, NederlandAs Product Security Subject Matter Expert, you hold a key position in our RBA (Risk & Business Assurance) Expertise Security sector, ensuring Product security capabilities are defined, implemented and monitored. · **Role and responsibilities** · ASML brings together the most crea ...
-
Manager Standards
6 dagen geleden
Damen Workboats BV Gorinchem, Nederland**ABOUT US**: · - As a department Manager for Standards & Documentation, you are responsible for managing and implementing documentation related to maritime standards and guidelines. This will be achieved with various teams and stakeholders to ensure that documentation and the pr ...
-
Foreman Wtb
4 dagen geleden
Oranjegroep Rotterdam, Nederland**WORKING AT MECHANICAL**: · **THE BOUNDLESS POSSIBILITIES**: · **WHAT WE OFFER YOU**: · - Weekly payment · - Contract for 40 h per week · - Possibility of a permanent contract. · - Possibility to work overtime · - Accommodation if needed · - We provide Tools and Orange PPE · - P ...
Senior Manager Validation Compliance Engineering - Breda, Nederland - Amgen
Beschrijving
If you feel like you're part of something bigger, it's because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us as:
Senior Manager Validation Compliance Engineering
At Amgen Breda medicines are labelled, assembled, stored and eventually shipped to various countries worldwide. Every day more than 1000 people with 42 different nationalities are working on supply chain processes, manufacturing, marketing and sales of our medicines and clinical research into new medicines.
Live
What you will do
Our Site Engineering team is responsible for the process development, equipment engineering and maintenance of our assets. As the Senior Manager Validation Compliance Engineering, you will be responsible for developing and implementing robust Validation, Compliance and Lean Transformation strategies within these teams. You will collaborate closely with various departments to ensure our engineering operations meet GMP compliance, quality & safety standards, and regulatory requirements. This role requires outstanding leadership skills, strategic agility, and the ability to influence partners at all levels.
Let's do this. Let's change the world. In this vital role you will:
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The new colleague we seek is highly motivated to join our mission and has these qualifications:
Thrive
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being. Therefore, Amgen is regularly recognized as Best Place To Work .
