דרושים Engineering/maintenance Tech Iii ב-טבע ב-ארהב

THE POSITION

This position is primarily responsible for performing operations related to the manufacturing and/or packaging of encapsulated pharmaceutical products through equipment set-up, operation, clean-up and maintenance in compliance with all regulatory cGMP requirements and company policies and procedures in manufacturing or secondary packaging.

Work Hours: Mon-Wed 6:00 am - 6:00 pm, and can work Thur 6:00 am – 10:00 am for 40 h

• Responsible for performing the manufacturing and/or packaging process as assigned by following approved batch records (BR), work instructions (WI), standard operating procedures (SOP), etc.
• Responsible for setting up, changeover, programming and operation of various manufacturing equipment and/or packaging equipment including, but not limited to, mixers, homogenizers, encapsulators, banders, etc.
• Responsible for cleaning of facilities, equipment and utensils as required following SOP’s and WI’s.
• Responsible for completing documentation as required in the manufacturing and/or packaging of product.
• Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.
• Performs job functions in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), and Batch Record instructions

Qualifications
Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:
• Requires a high school diploma or equivalent
• Requires a minimum of one year of previous encapsulation experience in a pharmaceuticalmanufacturingenvironment
Physical Requirements:
• Required to routinely wear personal protective equipment such as safety shoes, safety glasses, powered air purifying respirator, gloves, etc.
• May be required to stand for prolonged periods of time
• Occasionally lifting or moving heavy objects up to 50 pounds

We offer a competitive benefits package, including:

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

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 Maintenance Mechanic performs routine and preventive maintenance on facility equipment and systems with limited supervision. Responsibilities include operating and maintaining the conveying system, troubleshooting electrical/mechanical issues, and performing repairs in accordance with SOPs, safety policies, and manufacturer specifications. The role also involves managing spare parts inventory, recommending tools and supplies to improve efficiency, and supporting process improvements. This position requires knowledge of building systems in a large office/distribution facility and includes participation in an on-call rotation, with flexibility for overtime and varied scheduling.

ESSENTIAL AREAS OF RESPONSIBILITY

• Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
• Perform scheduled preventive maintenance and inspections on mechanical systems and equipment.
• Troubleshoot and repair mechanical issues on HVAC, plumbing, conveyors, motors and other systems.
• Maintain accurate documentation of maintenance activities and repairs.
• Respond to emergency maintenance requests promptly and efficiently.
• Performs basic building and equipment repairs (e.g. drywall, painting, floor patching, lighting etc.) using hand tools, power tools.
• Read and interpret blueprints, schematics, and technical manuals.
• Pick up and restock ordered parts and supplies.
• Ensure compliance with safety standards and company policies.
• Participates as a member of the Company’s Emergency Response Team.
• Participate in an on-call rotation to respond to emergency maintenance requests outside of regular working hours.
• Work a flexible schedule, including overtime, weekends, and holidays as needed.

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:
• High School diploma or equivalent, and prefer hands-on or vocational school training, and a minimum of one (1) year of experience as a general maintenance mechanic in a warehouse environment, or an equivalent combination of training and experience.
• Must possess a Valid Driver’s License.
• Familiar with OSHA requirements and safe practices.
• Mechanical aptitude and basic mathematics.
• Qualified and able to work with power tools and lift equipment.
• Must be a highly motivated self-starter with a proactive approach to identifying and resolving issues.
• Ability to balance multiple tasks simultaneously and effectively.
• Demonstrated ability to work well with diverse cross-functional groups or independently.
• Strong organizational, problem-solving and decision-making skills.
• Good written and oral communication skills
• Interpreting and applying Federal, State and local policies, procedures and regulations for FDA, EPA and OSHA.
• Familiarity with CMMS (Computer Maintenance Management System) is a plus.

Skills/Knowledge/Abilities:
• Ensure compliance with safety, environmental, and waste management policies by recognizing hazards and taking appropriate corrective actions.
• Analyzing and troubleshooting minor problems with equipment, identifying solutions, recommending and implementing methods, procedures and techniques for resolution.
• Performing preventative maintenance on all assigned equipment and operating systems. Performing repair techniques including cutting, drilling, gluing, caulking, fastening of plastic, wood and milled steel.
• Basic electrical and mechanical control and/or operating systems.
• Maintaining a clean and orderly work area.
• Demonstrate basic computer literacy, including the ability to operate a personal computer, navigate software applications, and utilize systems such as CMMS (Computerized Maintenance Management System) for tracking maintenance activities and inventory.
• Read and interpret schematics, technical documents, and both written and verbal instructions to perform maintenance tasks accurately and safely.
• Communicating clearly and concisely, both orally and in writing.
• Establish and maintain cooperative working relationships with individuals contacted in the course of work.

PHYSICAL REQUIREMENTS

Occasional:
• Incumbents in this class are subject to extended periods of sitting, standing, walking, pushing and pulling, stooping and crouching climbing and walking, vision to monitor, occasional lifting of equipment or materials weighing up to 75 pounds. Incumbents may be exposed to toxic materials, toxic gases, electrical hazards, and dangerous tools and equipment. Work is performed in a fast-paced distribution environment.
Visual Acuity:
• Perform activities such as computer work, preparing and analyzing data, and extensive reading.

WORKING ENVIRONMENT

Use of PPE (Personal Protective Equipment) required.

CAREER GROWTH & DEVELOPMENT

We offer a competitive benefits package, including:

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

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.

· Lead site-wide production and materials planning, inventory control, and product project management.

· Drive strategic planning using SAP/APO and other ERP tools to optimize capacity and resource allocation.

· Collaborate with Market Planners and external suppliers to ensure supply continuity and support new product launches.

· Champion the Sales & Operations Planning (S&OP) process, presenting capacity status and resolving bottlenecks.

· Build and mentor a high-performing team, fostering talent development and succession planning.

· Partner cross-functionally with R&D, Commercial, and Manufacturing to align supply chain strategy with business goals.

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

• Bachelor’s degree required; advanced degree preferred.
• Minimum 10 years of experience in pharmaceutical manufacturing, supply chain, or materials management.
• Proven experience in generic pharma operations and SAP/APO systems.
• Strong understanding of cGMP and regulatory requirements.
• APICS certification preferred.
• Exceptional leadership, communication, and cross-functional collaboration skills.

Skills/Knowledge/Abilities:

• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), ERP system such as SAP or Oracle and manufacturing/quality systems such as Trackwise and Qdocs.
• Self-directed with ability to organize and prioritize work.
• Ability to motivate, influence and lead others with and/or without direct supervisory authority.
• Ability to positively manage conflict, provide difficult feedback and negotiate resolution.
• Ability to build and maintain collaborative relationships between teams, departments, business units and external partners.
• Ability to demonstrate sound judgment and decision making.
• Ability to identify the developmental needs of others and provide coaching, mentoring and encouragement to help others improve their knowledge or skills.
• Ability to communicate effectively with excellent written and oral communication skills.
• Project management and advanced presentation skills preferred.

TRAVEL REQUIREMENTS: Up to 20%

We offer a competitive benefits package, including:

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.

Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

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 ITOA Administrative Assistant plays a key support role within the ITOA European organization, helping to ensure smooth operations by handling administrative tasks for the region. The ITOA Administrative Assistant is responsible for coordinating both the internal IT team and outsourced vendors/partners as required and acts as the point of contact for supporting day-to-day and project-related administrative tasks.

Major duties and responsibilities:

• Serve as the primary point of contact for internal ITOA requests and communications (European Region).
• Schedule and coordinate meetings, training sessions, and project timelines for the IT team.
• Assist with the preparation, formatting, and distribution of IT documentation, reports, and presentations.
• Supplier Management - Onboard new suppliers into the Ariba system. Maintain and update supplier records.
• Maintain inventory of IT equipment and supplies; assist with procurement and asset tracking.
• Support onboarding and offboarding processes by coordinating IT access, hardware, and software setup.
• Manage and update ITOA department records, including software licenses, contracts, and service agreements.
• Process invoices and purchase orders related to ITOA purchases.
• Liaise with vendors and service providers as needed.
• Ensure compliance with company policies and IT security procedures.

Either our, Castleford site or

Do You Have:

• Previous experience as an administrative assistant, preferably in an IT or technical environment.
• A qualification(s) within Business Administration, IT or Customer Service would be advantageous.
• Proficiency with office software (M365) and a basic understanding of IT terminology and processes.
• Experience with asset management or procurement systems.

Are You:

• Well organised with strong multitasking skills.
• A confident communicator both in writing and verbally.
• Bringing a keen eye for detail and proactive in your approach to problem-solving.
• Able to handle confidential information with discretion.
• Comfortable working independently and as part of a technical team.
• Prioristing professionalism and placing upmost importance on customer service delievery.
• Able to work in a fast-paced environment and handle multiple tasks simultaneously.

Whether you're growing your family or pursuing new adventures, our enhanced maternity and paternity leave, sabbaticals, and hybrid working policies are here to support you through life’s most meaningful moments. Financial wellbeing matters too, which is why we offer an enhanced pension scheme, access to a discount store, and free financial coaching through Bippit.

To help you grow with confidence, we offer a structured training and development programme tailored to your role and department, equipping you with the tools, knowledge, and support you need to thrive.

David Flaherty,

Director IT, Europe Onsite Service Support

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.

We are seeking an Engineering Qualification, Manager to lead project management, commissioning, and qualification activities for facilities, utilities, and computer systems. Responsibilities include developing and executing project plan, qualification documentation, ensuring compliance with GMP and industry standards, and mentoring team members.

• Fulfills responsibilities according to organizational policies, procedures, and applicable state, federal, and local laws.
• Reviews manufacturer and blueprint specifications for electrical, mechanical, and software/computer systems to identify critical parameters.
• Prepares Qualification Project Plans and protocols (IQ/OQ/PQ) that test the critical parameters relevant to installation, operation, and performance for facilities, utilities, computer systems, or equipment.
• Ensures protocols receive approval through appropriate channels; drafts and updates validation protocols as needed.
• Executes validation and qualification protocols following relevant SOPs and verifies that acceptance criteria are satisfied.
• Records all test data in compliance with cGMP requirements.
• Prepares final reports and ensures proper approval.
• Develops and communicates project timelines and status updates.
• Adheres to GMP and safety requirements, SOPs, and company policies and procedures.
• Completes related duties as assigned.
• Conducts periodic reviews of equipment and system qualifications, prepares summary reports, and manages CAPAs for any identified deficiencies. This includes reviewing change controls, deviations, work orders, IQ/OQ, URS, drawings, and FS/DS where applicable.
• Prepares or updates Site Validation Master Plans.
• Develops and applies FMEAs, RCAs, and other investigative tools for failures and investigations.
• Conducts risk assessments associated with qualification activities, change management processes, or quality investigations.
• Possesses technical knowledge of computerized systems/equipment, preferably in solid oral dosage manufacturing, facilities, and utilities.
• Has familiarity with GAMP and CFR 21 Part 11 requirements.
• Demonstrates effective oral and written communication skills in English.
• Works independently with limited supervision.
• Capable of writing protocol deviations and identifying root causes and corrective actions.

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

• Bachelors in Engineering required (Chemical or Mechanical)
• Master’s in Engineering Preferred(Chemical or Mechanical) and Project Management
• 5-7 years of experience within pharmaceutical or related manufacturing facility.
• Preferred previous experience in a manufacturing environment within pharmaceutical industries.
• Experience in development and execution of qualification protocol/reports as related to automated equipment/systems and computer systems preferred.

• Strong technical expertise in computerized systems, automation, and digital analytics.
• Proficiency in Power BI, Excel, Python, and other digital tools for data management and analysis.
• Knowledge of GMP, GAMP guidelines, CFR 21 Part 11 compliance, EMA, ANVISA, HC, PRC, PIC, etc. and risk management related to computer systems.
• Ability to write clear protocols, manage deviations, and communicate findings effectively.
• Concise and organized writing of technical data.
• Works with multiple departments to gather and summarize findings.
• Understands manufacturing equipment functional parts including control systems, mechanical components, and electrical power.
• Interpreting software changes, diagrams and flowcharts, design drawings (blue prints) and/or construction drawings and specifications including but not limited to HVAC, CA, Water Systems.
• Communicating clearly and concisely, both orally and in writing.
• Strong technical writing skills.
• Pharmaceutical principles, practices and applications.
• Principles and practices of qualification and validation.
• Techniques and principles of sampling, testing and measuring of mathematical calculations.
• Mechanical and electrical concepts.
• Ensuring compliance with all company policies and procedures, including safety rules and regulations.

Problem Solving:
• Proactively works on problems of a complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.
• Seeks out support and resources when selecting methods and techniques for obtaining problem resolutions.

TRAVEL REQUIREMENTS

• N/A

We offer a competitive benefits package, including:

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.

Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

Associate Director, Site Engineering

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.

Key Responsibilities:
• Support implementation of new solutions, testing, management, troubleshooting, and administration of new and existing systems within the pharmaceutical laboratory research and development organization.
• Support delivery of IT services and coordination with local, regional and global resources on the status of projects, service and support efforts.
• Collaborate with laboratory business, staff, IT colleagues, vendors, and other stakeholders to support existing processes and technologies. Identify customer requirements; assess impacts to the delivery of applications and other IT functions.
• Involved in implementation of new releases, upgrades and changes in accordance with Computer Systems Validation (CSV) standards.
• Perform day-to-day system administration, maintenance & operational tasks for the Lab systems and ensures appropriate service levels are developed and monitored.
• Perform PC/System specification configuration according to vendor requirements, works with IT Operations for PC lab build, user group assignment and management, data backup setup and control, test data backup and restore, IQ/OQ test execution and documentation.
• Liaise with IT operational support teams for the peripheral equipment, such as servers, desktops, printers and storage devices.
• Support with tasks and deliverables related to Software Development Life Cycle (SDLC) phases for laboratory computer systems. Ensures that system implementations are in keeping with the relevant FDA 21 CFR Part 11, GxP guidelines as well as internal policies and processes.
• Ensure compliance with Data Integrity requirements and remediation activities for Laboratory systems.
• To be the site expert on all laboratory computer systems – LIMS (Labware), CDS (Empower), standard-alone computer driven instrumentation and other applications identified by laboratory management.
• Remotely support other Teva sites across multiple zones as needed.
• Backup & recovery management Commvault.

Qualifications
• Required: Bachelor’s Degree - preferably in Computer Science, Information Systems Management, Computer Engineering, Electrical Engineering, Life Sciences or a related field.

Key Skills and Experience
• Experience working in a highly regulated environment within the pharmaceutical laboratory environment.
• Knowledge and experience of cGMP and its implementation to laboratory instrumentation and laboratory processes.
• Experience in providing face-to-face and remote end user support to laboratory users and applications in a highly regulated environment within the Pharmaceutical Industry.
• Excellent verbal and written English communication skills.
• Knowledge of laboratory technical configurations
• Knowledge of installation of system software and tools
• Knowledge of workflows in the laboratory space.
• Excellent Organizational Skills - ability to manage time and multiple tasks
• Strong problem-solving skills
• May have specialized external certification.
• Has developed proficiency in a range of IT processes or procedures through job-related training and considerable on-the-job experience in a laboratory environment

• Proven experience working as a validation analyst
• Extensive experience in regulated biotech or pharmaceutical companies
• Experience in regulated environment (GLP, GCP or GMP)
• Experience in 21 CFR Part 11, GAMP
• Experience in SDLC (Agile or Waterfall)
• Experience in providing face-to-face and remote business analyst support to laboratory system users in a highly regulated environment within the Pharmaceutical Industry.
• Successful experience working in a team environment and with a multi-disciplinary and global team.

We offer a competitive benefits package, including:
• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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.

• Strategic comprehensive management of a team that leads site unique drug product project activity (launches, operational validations, site transfers, material changes) by implementing project management best practices and tools
• Drive initiatives to adopt best practices and innovative project management methodologies
• Provide strategic direction for project plans, ensuring alignment with organizational KPIs, and monitor progress.
• Prepare and present detailed project reports to senior management and stakeholders.
• Manage stakeholder expectations, resolve conflicts, and escalate issues as needed.
• Identify, assess, and mitigate project risks, ensuring proactive management throughout the lifecycle.
• Launch management based on market demands, regulations synced with plant's production and quality units
• Manage validation activity by setting framework, planning and alignment across R&D and production unit
• Lead site transfer activity to ensure on time delivery and professional execution
• Execution of site AOP in a way that support customer service level of commercial molecule

• Academic degree in Industrial engineering and management, Materials / Chemical engineering or Life science – must
• Master degree in the same fields or MBA - advantage
• Robust project management experience (8-10 years min)
• Experience in managing large scale activities in pharmaceutical organizations
• Familiarity with R&D and Production processes
• Managerial experience (at least 5 years)
• Excellent analytical and problem-solving abilities.
• High execution skills
• Ability to motivate people into action
• Strong verbal and written communication skills.
• Effective time management and organizational skills.

Sr Dir Plnt/Ctry Sup Chain Lead

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.