Technical Operations Director Job

Job description

Technical Operations Director-00000ZZSDescription‘Caring for the world, one person at a time’... inspires and unites the people of Johnson & Johnson. We embrace research and science
- bringing innovative ideas, products and services to advance the health and well-being of people.
Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
Janssen Pharmaceutica joined the Johnson & Johnson group in 1961. Today, Janssen Pharmaceutica is one of the most innovative pharmaceutical companies in the world. Our research and development centre develops products for a wide range of disease areas, such as mental disorders, neurological problems, infectious diseases, immunological disorders, cancer, and cardiovascular and metabolic conditions.
The Technical Operations Director is responsible for day-to-day technical support of chemical production at the Geel site.
He/she will organize the technical support for NPI and Life Cycle Management initiatives.
He/she is responsible for the execution of standards and delivery of business results on site.
He/she is accountable for the Chemical Process and Cleaning Validation Masterplan and execution of related Performance Qualification for both chemical and cleaning processes.
He/she is the system owner of the FDA system Manufacture of a Product and directly responsible for the sub system Process Validation and Cleaning also in the context of Regulatory Inspections for these area.
The Technical Operations Director will manage a Technical Operations (TO) Team with the dedicated focus on1. NPI / LCM
- Technology transfer coordination on site2. LCM – Technology transfer coordination to external partners3. PQ, validation execution (Process and Cleaning Validation)4. Process improvements execution5. Standards deployment, PAT, process technologiesHe/she will report dotted line to the Site General Manager and solid line to the TO Technology Platform Lead.
He/she will be a member of the global tech ops team for Small Molecule APIsThe Site Technical Operations Lead will lead a team of Scientists and Engineers (Cleaning and Process Validation Experts, technical writers, document managers and Project Managers) across the Site Business Units in span of control of the site.
PRINCIPAL RESPONSIBILITIES
- Manage Product Transfer /Product Introduction for commercial manufacturing of the Site
- Define the project Scope, Objectives and Success Criteria
- Perform the Technical Assessment
- Develop Project Strategy/Plan
- Develop the team and define Interfaces with Technical Operations Global Functions, engineering, QA and Operations
- Process performance Qualification
- Process Transfer, Characterization and Verification (including Cleaning)
- Project Evaluation, conclusions and process optimization opportunities
- Technology & product technical life cycle management
- Partnering with Product Stream Lead, site GM and BUs on project priorities.
- Partnering with Engineering, QA and Production on Project Oversight of project assigned as well as day to day investigations, escalations.
- Partnering with Technology and Standardization stream on URS and technology deployment
- Manage the Process and Cleaning Validation Masterplan of the site
- monitor technical process and product performance
- Lead or support complex failure investigations (escalation of quality or compliance events)
- Innovation & Standardization (Evaluate new technologies such as PAT ; Contribute to Standardization initiatives for Technical Operations)
- Inspection Readiness and Execution:
- Accountable for the Site Process and Cleaning Validation Masterplan
- Technical support in partnership with Quality on any regulatory audits and inspections
- Being the subject matter expert in Audits internal and externalQualificationsEducation & experience
- A Master degree in a numerate discipline
- engineering, science is preferred; A Bachelor's degree is required;
- A minimum of 10 years of experience in a pharmaceutical environment;
- Strong expertise in chemical manufacturing processes, technologies and products
- Project management (FPX), organizing, planning and coordination skills;
- Process excellence (6sigma), lean concepts and tools;
- Strong knowledge of Quality & Compliance / regulatory requirements (GMP/EH&S)
- Business acumen, financials (budgeting & costing).Languages
- English: Fluent (written and spoken) is required
- Local language: Fluent (written and spoken) is an added valueCompetencies
- Ability to lead cross functional teams;
- Ability to interact at different levels of the organization;
- Ability to work under pressure, handle conflicting interests, and take decisions;
- Ability to work independently under general direction, having a good sense of prioritization of assigned tasks goals and manage time accordingly;
- Costumer and business focus;
- Team player;
- Drives for innovation and change to ensure competitiveness;
- Can-do mentality, agility & flexibility to work with stretched goals and deadlines;
- Willing to place the goals of the team first and work with others towards these goals;
- Communicative / Motivator / Negotiator / assertive person having impact;
- Showing a high sense of responsibility regarding professional activities.
Location:
- This function is based at our Geel site in Belgium
- Travel: Min 5%Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-GeelOrganization: Janssen Pharmaceutica N.V. (7555)Travel:Yes, 10 % of the TimeJob Function: Plant Management