דרושים Manager Network Engineering ב-טבע ב-Croatia, Zagreb

Technology SME Leader for Sterile and Bio production

The Engineer will provide the overall subject matter expertise on Global level, on a cluster level and on a site level as needed.

Scope of Subject Matter Expert support may include – Standardization processes, Compliance GAP CAP, Reliability improvements, Machine, Facility and Process design and PS, RA processes.

This role can be based in one of our following European based sites, Croatia (Zagreb), Netherlands (Haarlem), United Kingdom (Runcorn), Romania (Bucharest), Lithuania (Vilnius) or Ulm (Germany).

BP scope through the above site processes and monitoring framework, focus but not limited to:

• CAPEX – LRP, AOP, routines, financial performance, KPIs management.
• PRODEX – Planning and management of three Eng. Related budgets – Energy, Maintenance, Consumables.
• GMI – Saving initiatives planning and projects execution.
• People – agile organization, risk management, community building.

• BS. Degree in Engineering (Mechanical/Electrical/Chemical/Industrial)
• MBA Degree - Advantage
• At least 10 years’ experience in Aseptic/Sterile technologies.
• Complex manufacturing (Respiratory, patches, etc.) - nice to have
• Experience in sterile and bio - must have
• Coordinating initiatives in a complex global environment.
• Equipment Reliability and understanding of OPEX principles.
• Excellent understanding of Aseptic/Sterile equipment industry standards and major OEM players.
• Understanding trends in equipment technology across the pharma industry.
• Large, complex, multi-level organizational interface experience.
• Global, multinational experience.

Languages:

• Fluent in English. Additional languages advantage.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Croatia, Romania or Poland

• Support the development, maintenance, and implementation of medical communication strategy, plans, and tactics in the assigned therapeutic area(s) and manage relationships with both internal and external stakeholders
• Understand and interpret clinical trial data, the literature and associated therapeutic conditions
• Coordinate cross-functional publication strategy and core teams in the development of medical publications and scientific congress strategy and plans
• Ensure execution of publication plans is consistent with department objectives and TA strategy
• Ensure oversight of publication records in Teva’s publication tracking tool
• Understand industry and publication guidelines, ICMJE and GPP in particular
• Provide input into key medical/scientific communications concepts and terminology development
• Be accountable for the timely delivery of high quality, message-focused medical communications to target audiences
• Establish and leverage relationships with external experts, clinical trial investigators, journal editors, and congress secretariats to drive high quality medical communications activities
• Develop and maintain general or special issues publication advisory boards for assigned therapeutic areas, including recruitment of advisors, meeting planning and execution, content development, and documentation of action items
• Forecast financial resources with business case preparation and oversight as required and to deliver the publication plans within budget
• Integrate medical communications agencies/contract freelancers as part of the extended team for medical communications activities
• Acquire and maintain thorough understanding of industry and publications standards with respect to quality, authorship and appropriateness of medical/scientific communications
• Ensure that medical/scientific communications activities are within compliance

• Bachelor of Science or Communications degree required; advanced scientific degree preferred (MD, PhD, PharmD)
• Minimum 3 to 5 years of experience in Industry with relevant medical/scientific focus
• Knowledge of Good Publication Practices and ICMJE Guidelines
• Knowledge of Global Medical Affairs in the Pharmaceutical/Biotech Industry
• Proven track record of establishing strong partnerships with senior stakeholders as well as delivering medical communications plans and tactics
• Project management skills and financial acumen
• Experience with management of publication projects via publication tracking database (i.e. Datavision, PubStrat)
• Excellent interpersonal and communications skills
• Strong client engagement and relationship management skills
• Ability to influence and work with cross-functional teams to deliver complex projects
• Experience with Medical Affairs and Medical/Scientific Communication practices and processes

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

• Requirement Analysis: Analyze business requirements and perform thorough Impact analysis
• Solutioning & Design: Solutioning for new SAC (SAP Analytics Cloud) planning application implementations and also for enhancements to existing planning applications.
• Prepare High level and detailed design specifications related to SAC Planning model and Import/Export interfaces from/to SAP BW/Datasphere/Oracle databas
• Collaboration: Collaborate with Technical, Stakeholder management and Cross functional teams
• Delivery : Contribute and lead the delivery of SAC Planning application Implementation, enhancements and Interface developments
• Project Status updates : Timely updates of the ongoing development tasks and incident resolution status to the management and concerned teams
• Technical Ownership : Assume technical ownership ensuring tight control over all the technical aspects of the application and adhering to established governance and best practices
• Project Support: Monitor Service Now incidents, JIRA tasks and track them to closure
• Technical Documentation: Prepare and maintain the technical documentation and user guides

• : Bachelor's or Master's degree in Finance, Accounting, Business Administration, or Information Technology.
• 12 + years of experience in the areas of Planning and Analytics
• Minimum 3-4 end to end Planning/Budgeting/Forecasting implementation experience using SAC (SAP Analytics Cloud) Planning
• Strong Understanding and experience of implementing Financial Planning and Standard Financial statements : P&L, Balance Sheet and Cash Flow is a must
• Experience in developing Advanced formula, Data actions
• Extensive experience in Stories and dashboards with rich visualization.
• Experience with setting up User Security in SAC
• Experience with Inbound and Outbound data integrations/interfaces with upstream and downstream systems is a must
• Experience with scripting for Analytical applications is an added advantage
• Strong excel skills
• Data reconciliation and troubleshooting skills
• Hands-on experience with SAP BW / SAP Datasphere
• Hands-on experience in developing simple to Medium complexity SAP HANA Calculation views
• Good Understanding / Hands-on experience in SQL is an added advantage
• Past experience in other Planning tools like BPC standard, BPC Embedded , BW-IP, Hyperion Planning etc. is an added advantage
• Client interfacing skills and experience in interfacing with Senior management and Business users/end users
• Self motivated and quick learner and has the ability to adapt to highly dynamic environment

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

The Manager, Complex Gx, Regulatory Affairs is responsible for the supervision, preparation, critical review, and submission of high quality regulatory submissions—both pre- and post-approval—for U.S. FDA-regulated sterile complex generic products. The manager evaluates complex regulatory issues and provides accurate and timely recommendations and alternatives, as needed, to his/her supervisor. The manager serves as team leader for projects and is responsible for overseeing the evaluation of change controls. He/she will help to establish regulatory strategies for submissions and manage document deliverables to ensure submission targets are met while adhering to appropriate regulations and guidance’s. The manager will oversee any/all regulatory or team databases and trackers and will accurately update them when changes are required. The primary responsibilities of the Manager include the preparation and compilation of original applications, amendments, deficiency responses, postapproval supplements, and training of regulatory staff.

• Independently support the preparation, review, and compilation of regulatory submissions (original applications, supplements, and responses) for sterile complex generic products.

• Support early FDA engagement to align on development strategy, reduce regulatory risk, and support first-cycle approvals.
• Support regulatory assessments and decision-making for significant changes, including site transfers and alternate API sourcing.
• Ensure submission documents are accurate, complete, and compliant with FDA regulations, promoting a Right-First-Time approach to maximize first-cycle approvals.
• Collaborate with cross-functional teams (e.g., R&D, QA, Manufacturing) to resolve regulatory challenges and streamline processes.
• Champion continuous improvement initiatives and introduce innovative solutions to enhance regulatory efficiency.
• Oversee regulatory documentation systems, ensuring data integrity and consistency across submissions.
• Other projects and duties as required/assigned.

• Pharm D/BS in a scientific discipline or equivalent education and related experience

• Master’s degree in RA/QA discipline, preferably in Pharma.

• Minimum 8+ years pharmaceutical industry experience required; 5+ years Regulatory Affairs experience with sterile products required, coupled with 2 years analytical/QC, R&D/laboratory or production experience is preferred.
• Demonstrates an understanding of ICH and FDA guidelines
• Demonstrates the ability to evaluate regulatory documents and determine appropriate action.
• Demonstrates excellent verbal and written communication skills.
• Shares concepts, ideas, information, and suggestions with management, peers and others.
• Demonstrates the ability to establish and maintain good working relationships at all levels of the company and with external contacts.
• Demonstrates excellent organization skills and the ability to multi-task; detail oriented.
• Possesses strong critical and logical thinking.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

1. Data Collection and Processing
   Promote and ensure accurate and efficient collection, processing of periodic environmental data collectionprocesses environmental sustainability data.
2. Data Integrity and Standardization Management
   Monitor, validate, Investigate, communicate and support improvements implementations to enhance dataaccuracy, consistency, and reliability.
3. Quantitative Data Reporting and Disclosure
   Consolidate and report (internally and externally) data in alignment with Sustainability team expectationsand Reporting system format;
   Regulatory or ranking platforms expectations.
   Validate per-assured data and escort assurance processes
4. Data Analysis, Interpretation and communication
   Conduct in-depth analyses to answer management queries, identify trends, insights, and opportunities forimprovement. Operate predictive model to support environmental performance forecasting and decision-making (e.g. Decarbonization Model).
   Provide clear and data visualizations to support effective communication, different stakeholders andbusiness needs.
5. Advisory on Data Management Enhancement
   Provide insights and recommendations for data management improvements through lessons learnedsessions and prioritized projects

Data Management & Processing

• Proficiency in Excel (advanced), Power Query, and data wrangling technique
• Experience with ETL processes (Extract, Transform, Load)
• Understanding of data integrity, quality control, and standardization

Data Analytics & Modeling

Competency in data analysis using tools such as:

• Power BI developer (for dashboards and visualizations)
• Python or R (for deeper statistical or trend analysis) – optional but preferred
• Experience operating or maintaining predictive models (e.g., emission forecasting, MACC, cost-benefit analysis)

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Technical Accounting & Compliance

• Provide expert guidance on complex accounting topics in collaboration with local and corporate teams.
• Ensure adherence to US GAAP, local GAAP (European countries), and internal accounting policies.
• Stay current with changes in accounting standards and regulations and disseminate updates to relevant stakeholders.
• Support ERP pushdown of local GAAP requirements.

Financial Reporting & Analysis

• Prepare and review detailed financial reports (consolidated and standalone) and presentations for local management.
• Support quarter-end closing activities.
• Perform in-depth analysis of financial statements and provide actionable insights.

Balance Sheet & Reconciliation

• Oversee and support the accounts reconciliation process across multiple entities.
• Ensure reconciliations and journal entries are compliant with policy requirements.

Audit & Statutory Reporting

• Coordinate audit activities and schedules across multiple locations.
• Ensure compliance with internal and external audit requirements.
• Assist in the preparation and review of statutory accounts in collaboration with local teams.

Leadership & Support

• Support the Head of Local Accounting in all accounting-related topics.
• Mentor and guide accounting experts within the team.
• Contribute to process standardization and improvement initiatives.
• Developing and documenting business processes.

• University degree in Accounting, Finance, or related field.
• Professional certification (e.g., CPA, ACCA) strongly preferred.
• Minimum 8–10 years of progressive experience in accounting and financial reporting.
• Strong knowledge of US GAAP and local GAAP (European countries).
• Experience in multinational environments and GBS preferred.
• Proven ability to lead cross-functional initiatives and communicate effectively across teams.
• Fluency in English, both written and spoken, is essential for effective communication in this role

• Excellent analytical and problem-solving skills.
• Strong interpersonal and communication abilities.
• Ability to manage multiple priorities and deadlines.
• Proficiency in ERP systems and financial reporting tools.
• High attention to detail and commitment to accuracy
• Ability to travel

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

• Develop and deploy TPM methodologies, including Autonomous Maintenance and Focused Improvement
• Align TPM rollout with TLMS principles and site maturity levels
• Design and implement global reliability tools (e.g., FMEA, RCM, Root Cause Analysis)
• Lead cross-site benchmarking and best practice sharing for both technical and operational excellence solutions
• Support collaboration with Global TLMS Pillar leaders and drive proper synergies and integration with the rest of the journey
• Support cultural change and capability building in maintenance and engineering teams
• Collaborate with site teams to implement TPM pillars and measure impact on Overall Equipment Effectiveness and downtime
• Define (in coordination with global Key performance Indicators program), align and track TPM-specific Key performance indicators and improvement program/roadmaps
• Conduct reliability assessments and develop action plans to address identified gaps
• Facilitate workshops and training sessions to build TPM capabilities across sites
• Provide on the floor, hands-on support to tackle major losses for the sites. Coaching the team on how to tackle losses using the TLMS tools
• Monitor and report on the progress of TPM initiatives and their impact on operational performance
• Establish good engineering practices related to maintenance as well as building community of practices and knowledge hubs
• Co-design TPM roadmap and TPM steps evolution for advanced problem solving tools like Work point analysis, Advanced condition based analysis tools, In depth analysis on recurrent breakdown, etc.
• Support in person and remote Pillar assessment as key enable for site phase progression
• The role requires more than 30% travel time

You are

• A leader with demonstrated success in leading reliability improvement initiatives across all sites
• Someone with an analytical mindset and ability to interpret data and drive decisions
• Strong facilitator with coaching skills for cultural and behavioral change trough remote and on site support
• Experienced in conducting training sessions and workshops for engineering teams
• Fluent in English

You have

• Bachelor’s or Master’s degree in Mechanical, Electrical, Industrial Engineering, or related field
• More than 10 years of experience in maintenance, reliability, Operational excellence or continuous improvement roles in a manufacturing environment in pharma, food, or automotive industry
• Hands-on experience with Total Productive Maintenance implementation and Lean Manufacturing systems and related pillars
• Deep knowledge of maintenance strategies and reliability engineering principles
• Experience with tools such as Failure Mode and Effects Analysis, Reliability-Centered Maintenance, Root Cause Analysis, and Overall Equipment Effectiveness analysis
• Experience in implementing predictive maintenance strategies using SAP PM
• Proven track record in managing global spare parts inventory and optimization project
• Lean Manufacturing or Total Productive Maintenance certification (i.e. from Japan institute of Plant Maintenance or Black belt); Certified Maintenance & Reliability Professional (CMRP) or equivalent is preferred
• Proven experience in management of change for organizational and technical initiatives

VP, Head of Engineering Center of Excellence

Miha Pongrac
Human Resources

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.