Toxicological Risk Expert
hace 24 horas
Vallés
Expect to grow, personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you’ll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.Your RoleThe primary purpose of the role is to protect operator health and ensure environmental compliance across all sites by conducting comprehensive toxicological risk and safety assessments (ExpoCat reports) for Active Pharmaceutical Ingredients (APIs), intermediates, and other chemicals. Acting as the scientific pillar for industrial hygiene and equipment containment strategies, the job holder provides critical support to cross‑functional departments, including SHE, Quality, Business Development, Project Management and Engineering.Key responsibilities include:- Identifying product‑related risks – calculating Occupational Exposure Limits (OELs), defining ExpoCat classifications, and preparing timely reports to facilitate safe operations and new product decision‑making.- Ensuring audit/inspection readiness through robust, traceable toxicological justification and documentation.Your ProfileAs a Toxicological Risk Expert on our Corporate SHE & S team in Barberà del Vallès, your main responsibilities will be:- Toxicology and Risk Assessment – Research and evaluate data (preclinical, clinical, toxicological) to identify potential risks; conduct science‑based risk assessments for new and existing APIs, drug products, intermediates and other chemicals across all global manufacturing sites. Prepare structure safety assessments addressing genotoxic risks. Adhere strictly to current scientific standards and guidelines.- Occupational Exposure Limits & Hazard Classification – Calculate, establish and document internal OELs and Permitted Daily Exposures (PDEs) using a risk‑based approach. Define and assign ExpoCat classifications for all handled substances; perform regular reviewsand ensure timely revisions.- Global SHE Support & Cross‑Functional Advisory – Actively contribute to the API committee; partner with Business Development and Project Management to evaluate toxicological feasibility of new products. Provide global occupational safety support through risk analysis, hazard assessments and responsive product‑specific inquiries.- Technical documentation, Compliance & Audit Readiness – Serve as subject‑matter expert for OEL/PDE and ExpoCat topics, author and maintain high‑quality provisional and final reports; keep documentation audit‑ready in line with local regulations and international frameworks.- Training, Leadership & Continuous Improvement – Develop training materials, deliver training on ExpoCat reports, keep supervisors informed, support process improvement initiatives and share knowledge with the team.Ideal Background and EducationUniversity degree in medicine, pharmacy, biology, biochemistry or related discipline with a MSc/PhD in toxicology or related field. Board certification as a Registered Toxicologist (e.G. ERT) is highly preferred. Coursework or certifications in Industrial Hygiene, Occupational Health or Environmental Toxicology are a plus. Practical knowledge or formal training in “in silico” toxicological assessments (QSAR modelling, read‑across methodologies, structural alerts) is highly desirable.LanguagesFluent English (C1‑C2); other European languagea plus.TravelExpected 10–20% travel.Experience- Minimum 3+ years hands‑on experience in toxicological risk assessment, preferably in pharmaceutical, chemical or regulatory consulting.- Proven experience calculating and documenting OELs and PDEs.- Strong familiarity with occupational exposure banding and acute hazard communication protocols.- Deep understanding of international regulatory frameworks and guidelines (EMA, ICH, ISPE, REACH, OSHA).- Experience working with cross‑functional teams (SHE, Industrial Hygiene, Quality assurance, Engineering, Business Development).- Experience leading/supporting SHE audits and external inspections, and closing CAPAs related to exposure limits.Key Skills & Competencies- Pragmatic & solution‑oriented assessment – translate complex data into practical, safe and operationally feasible solutions.- Advanced analytical & conceptual thinking – evaluate scientific literature and computational models to form evidence‑based conclusions.- Decisiveness under uncertainty – make confident recommendations with incomplete data.- Effective interface communication – explain complex concepts clearly to non‑experts and stakeholders.- Structured & goal‑oriented work style – maintain high organization and timely delivery of risk assessments.- Regulatory knowledge & auditing skills – defend internal OELs/PDEs to health authorities and manage CAPAs.- Process improvement & mentoring – optimize SHE workflows, manage databases and train colleagues.Your Benefits- Annual Bonus- Two days of home office per week- Free parking- Good public transport access to the site- Subsidized canteen on‑site or restaurant ticket for eating out or working from home- Medical, life, and accident insurance- Access to “Club Siegfried”: exclusive platform with discounts on over 400 servicesFounded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 16 sites across three continents. With a team of more than 4,200 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations that can carry out the development and manufacturing of APIs and finished dosage forms under one roof, making us the most trusted partner in the pharmaceutical industry.#J-18808-Ljbffr
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