Director Operations & Engineering CSS (Clinical & Specialty Services) (M/F/D)
Director Operations & Engineering CSS (Clinical & Specialty Services) (M/F/D)
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Job Description
Job Title: Director Operations & Engineering CSS (Clinical & Specialty Services)(M/F/D)
Reports to: General Manager
Location: Schorndorf Germany
Position Summary
The Director Operations & Engineering is responsible for providing strategic leadership direction and management of both manufacturing operations and engineering functions. This role combines operational excellence in Clinical trial packaging with engineering leadership for capital projects maintenance operations and continuous improvement initiatives. The position holder will ensure safe GMP-compliant cost-effective production and packaging of pharmaceutical products while leading engineering & maintenance operations and capital projects. As a key member of the senior leadership team this role drives organizational excellence across all operational and engineering functions.
Key Responsibilities
Operations Leadership
- Lead and control safe GMP-compliant cost-efficient manufacturing and packaging processes of solid dosage forms (tablets capsules) as well as vials syringes and bottles for clinical trials
- Establish appropriate organizational structure and staffing levels for manufacturing and packaging areas
- Supervise direct and develop Heads of Production for Manufacturing and Packaging
- Drive change initiatives innovations and foster associate involvement to enhance accountability and operational excellence
- Develop implement and review KPIs to continuously improve cost efficiency safety quality and compliance
- Build committed teams to manage order fulfilment personnel planning scheduling and productivity improvements
- Ensure compliance with all corporate and regulatory SOPs and cGMP guidelines
Engineering & Capital Projects
- Provide leadership of Engineering & Maintenance Operations Capital Projects site Master Plan and 5-year Capex Plan
- Organize manage and implement project plans designs and equipment assembly to ensure timely project completion in compliance with regulatory requirements
- Develop and regularly update strategic capital improvement plans and maximize production success through driving automation & innovation projects forward
- Support new business development with accurate capital project scope definition and cost estimates
- Manage large capital projects with focus on cost control project schedules and resource optimization
- Develop and maintain validated state for all GMP-relevant equipment and systems
Continuous Improvement & Compliance
- Collaborate with Black Belts/Lean Six Sigma associates to implement Best Practice processes including Lean Manufacturing Standard Work Six Sigma and TQM
- Ensure full compliance with OSHA national and corporate HSE and cGMP regulations
- Develop capital expenditure proposals justifications and recommendations
- Drive operational excellence and continuous improvement across all functions
- Represent the site on global engineering forums and collaborate on corporate engineering initiatives
Leadership & Team Development
- Recruit top talent and motivate/develop department members to be key organizational leaders
- Build and sustain employee engagement through efficient execution culture
- Establish effective cross-functional leadership relationships
- Actively participate in site leadership team decisions and strategic planning
Education & Experience
- Bachelors Degree in Engineering Life Sciences Manufacturing Operations Business or Logistics. Advanced degree (MS MBA) preferred
- 10 years of progressively increasing managerial experience in pharmaceutical environment
- 10 years of management positions including Head of Production experience
- 15 total years in regulated industry (pharmaceutical/FDA preferred)
- Essential experience in pharmaceutical sector with knowledge of manufacturing and packaging solid dose forms for clinical trials
- Demonstrable track record of delivering continuous improvement/OEE practices with strong management and leadership principles
- Broad and deep operational and engineering experience in pharmaceutical/bioprocessing environment
- Strong experience with Operational Excellence Lean Manufacturing Six Sigma Black belt or similar efficiency improvement programs
- Knowledge of FDA/MHRA/EMEA standards and audit experience
- Full understanding of pharmaceutical supply chain and regulatory standards (FDA GEP GMP GDP)
- Experience managing large capital projects on tight timelines and budgets
NOTE: CVs must be submitted in English in order to be considered.
Catalent bietet Mglichkeiten Ihre Karriere voranzutreiben! Werden Sie Teil des globalen Marktfhrers in der Entwicklung von Darreichungsformen von Medikamenten und helfen Sie uns Patienten auf der ganzen Welt ber 7.000 lebensrettende und lebensverbessernde Produkte anzubieten. Catalent ist ein spannendes und wachsendes internationales Unternehmen dessen Mitarbeiter direkt mit Pharma- Biopharma- und Consumer-Health-Unternehmen jeder Gre zusammenarbeiten um neue Medikamente von der frhen Entwicklung ber klinische Studien bis hin zur Marktreife produziert mehr als 70 Milliarden Dosen pro Jahr und jede davon wird von jemandem verwendet der auf uns zhlt. Machen Sie mit uns den Unterschied.
Persnliche Initiative. dynamisches Tempo. Bedeutungsvolle Arbeit.
Besuchen Sie Catalent Careers um Karrieremglichkeiten zu entdecken.
Catalent ist ein Arbeitgeber fr Chancengleichheit und diskriminiert nicht aufgrund von Merkmalen die durch lokale Gesetze geschtzt sind.
Wenn Sie aufgrund einer Behinderung fr einen Teil des Bewerbungs- oder Einstellungsverfahrens angemessene Vorkehrungen bentigen knnen Sie Ihre Anfrage per E-Mail senden und Ihre Anfrage nach einer Unterkunft besttigen und die Stellennummer den Titel und den Standort an angeben. Diese Option ist Personen vorbehalten die aufgrund einer Behinderung eine Unterkunft bentigen. Die erhaltenen Informationen werden von einem US-amerikanischen Catalent-Mitarbeiter verarbeitet und dann an einen lokalen Personalvermittler weitergeleitet der Untersttzung bietet um eine angemessene Bercksichtigung im Bewerbungs- oder Einstellungsverfahren sicherzustellen.
Hinweis fr Vertreter von Agenturen und Personalberatungen Catalent Pharma Solutions (Catalent) akzeptiert keine unaufgefordert eingesandten Lebenslufe von Agenturen und/oder Personalberatungen fr diese Stellenausschreibung. Lebenslufe die einem Catalent-Mitarbeiter von einer Drittagentur und/oder einer Personalberatung ohne gltige schriftliche und unterzeichnete Beauftragung vorgelegt werden gehen in das alleinige Eigentum von Catalent ber. Es wird keine Gebhr gezahlt wenn ein Kandidat fr diese Position aufgrund einer unaufgeforderten Empfehlung einer Agentur oder einer Suchfirma eingestellt wird. Vielen Dank.
Required Experience:
Director
Employment Type
Full-Time
