דרושים Intern - Data Scientist/data Engineer Davie Fl ב-טבע ב-ארהב

Embark on a future with an international pharmaceuticals company, contributing your creative energy to high-impact projects from the moment you arrive through the course of this 12 week experience. You will take part in meaningful work and real-life projects that will help you grow both professionally and personally throughout the program.

• Location: (West Chester, PA)
• Length: minimum of 12 weeks (TBD during mid-May through mid-August)
• Schedule: You must be available to work a 40-hour work week (onsite) for 12 weeks
• Pay: TBD

Tasks & responsibilities

• During the 12 week program, you will gain in-depth insight into the Global Statistical and Programming department.
• Supported by a mentor and experienced colleagues, you will be directly involved in our daily business and be assigned tasks within diverse projects.
• You will also play an important role in the development of concepts and initiatives within the (SDTM clinical programming) business unit.

• Currently enrolled in a Bachelor's or Master's degree in Computer Science or related field program.
• Strong programming skills in Python
• Fundamental understanding and experience in machine learning (supervised/unsupervised learning, model training, evaluation)
• Familiarity with ML libraries such as scikit-learn, TensorFlow, PyTorch, or similar
• Strong problem-solving and analytical skills
• Excellent communication skills and ability to work independently

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.

Embark on a future with an international pharmaceuticals company, contributing your creative energy to high-impact projects from the moment you arrive through the course of this 12 week experience. You will take part in meaningful work and real-life projects that will help you grow both professionally and personally throughout the program.

• Location: (West Chester, PA)
• Length: minimum of 12 weeks (TBD during mid-May through mid-August)
• Schedule: You must be available to work a 40-hour work week (onsite) for 12 weeks
• Pay: TBD

Tasks & responsibilities

• During the 12 week program, you will gain in-depth insight into the Global Statistical and Programming department.
• Supported by a mentor and experienced colleagues, you will be directly involved in our daily business and be assigned tasks within diverse projects.
• You will also play an important role in the development of concepts and initiatives within the (SDTM clinical programming) business unit.

• Currently enrolled in a Bachelor's or Master's degree in Computer Science or related field program.
• Strong programming skills in Python
• Fundamental understanding and experience in machine learning (supervised/unsupervised learning, model training, evaluation)
• Familiarity with ML libraries such as scikit-learn, TensorFlow, PyTorch, or similar
• Strong problem-solving and analytical skills
• Excellent communication skills and ability to work independently

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.

• Advise and guide end users regarding the use of a broad range of products, tools and services within the IT domain
• Follow a standard call flow and service request / incident handling processes: Verify entitlement, perform troubleshooting and problem determination. Resolve and close the ticket or route the ticket to the appropriate resolver team.
• Use technical resources and tools, answer end users’ queries.
• Utilize their product, technology, services skills to identify issues which may be related to products’ installation, updates, configuration, operation or performance.

• English – reading, writing, speaking
• Bachelor’s in computer science, Engineering, or related discipline with an IT certificate / diploma is preferred
• 1 to 3 years' experience as a technical service desk agent
• Worked as part of 7/24/365 global operations teams
• Excellent logical reasoning, troubleshooting and problem determination skills
• Knowledge and experience with Remote takeover tools• Understanding of ITIL (IT Infrastructure Library)
• Experience with ServiceNow or similar Incident Management Tool
• Knowledge on handling Service Requests and Incidents
• Knowledge on Email tools like MS-Outlook and MS-Exchange
• Knowledge on Networking (VPN/Connectivity Issues), Internet Security,
• Knowledge on Windows, Mac O/s (Basics), Android, iOS
• Knowledge on instant messaging tools like MS-Teams
• Working knowledge on O365
• Experience with working in a pharma / Biotech / GxP environment is preferred

First Line Manager

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.

Embark on a future with an international pharmaceuticals company, contributing your creative energy to high-impact projects from the moment you arrive through the course of this 12-week experience. You will take part in meaningful work and real-life projects that will help you grow both professionally and personally throughout the program.

• Location: West Chester, PA
• Length: minimum of 12 weeks (TBD during mid-May through mid-August)
• Schedule: You must be available to work a 40-hour work week (onsite) for 12 weeks
• Pay: TBD

Tasks & responsibilities

• During the 12-week program, you will gain in-depth insight into the R&D Global Statistics and Data Science department and Real-World Evidence (RWE) group.
• Supported by a mentor and experienced colleagues, you will be directly involved in our daily business and be assigned tasks within diverse projects that involves applying cut-edge statistical methods and using real-world data to generate insights and evidence for better understanding diseases and improving patient outcomes.
• You will also play an important role in the development of concepts and initiatives within the RWE Statistics business unit.

• Currently enrolled in PhD program of Biostatistics, Statistics
• Fundamental understanding and experience in statistical concepts and modeling, such as regression, survival analysis, multiple imputation, machine learning, etc.
• Experience in working with RWD and/or clinical trial data preferred

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.

ESSENTIAL AREAS OF RESPONSIBILITY

• Responsible for providing a thorough and timely review/approval or author/execution of cGMP documents and processes such as those related to deviations, investigations, equipment and facilities maintenance and calibration, protocols and reports, and facility controls, instruments, and procedures.
• Responsible for working with operating departments to facilitate process improvements and lean concepts.
• Responsible for leading cross functional improvement and process monitoring teams to mitigate unfavorable trends.
• Responsible for providing first response and ongoing QA presence for quality and compliance issues on the manufacturing floor and as needed in the laboratories.
• Responsible for evaluating reports of deviation from defined processes and working with QA to determine if incidents should be escalated to an event investigation.
• Responsible for conducting comprehensive investigations of critical, complex and/or challenging events as assigned.
• Responsible for serving as QA lead on research and development products and related document reviews/approvals – including change control items, protocols, batch records and deviations as applicable and product disposition.
• Responsible for working with the laboratory to investigate OOT and OOS events, providing feedback and manufacturing information.
• Responsible for compiling and maintaining metrics and tracking logs for site’s quality KPI’s or other functions.
• Responsible for supporting internal/external, scheduled and unscheduled audits of operational areas.
• Responsible for supporting activities within electronic systems as needed, such as LIMS, TrackWise, EAM.
• Responsible for serving as QA backup for final review/release of production batch records, managing the site change control system and for validation/qualification protocols and related activities.
• Responsible for completing training requirements and maintaining 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.
• Responsible for performing additional related duties as assigned.

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

Education/Certification/Experience:
• Requires a Bachelor’s Degree or equivalent with a minimum of seven years relevant progressive QA experience in the pharmaceutical or a related industry.
• Prefer degree in Science or Engineering.
• Preferred experience in a solid dose manufacturing environment.
• Requires experience with and an in-depth knowledge of cGMP and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
• Requires experience with the handling of deviations, investigations and CAPA’s.
• Experience with managing partner relationships preferred.
• Experience with Manufacturing/Quality systems such as Trackwise, Labware, Veeva, Learning Management Systems and statistical software preferred.
• Experience with laboratory related investigations/inquiries preferred.
• ASQ/CQE/CQA Certification preferred.Skills/Knowledge/Abilities:
• Detail oriented with ability to analyze information and create corresponding performance metrics.
• Computer proficiency with comprehensive working knowledge of MS Office products and computer relational databases.
• Ability to demonstrate sound judgment and decision making.
• Ability to build and maintain collaborative relationships between teams, departments and business units.
• Motivate, influence and lead others with and/or without direct supervisory authority.
• Communicate effectively with excellent written and oral communication skills.
• Interact positively and collaborate with co-workers, management and external partners.
• Manage conflict and negotiate resolution.
• Self-directed with ability to organize and prioritize work.
• Project management and advanced presentation skills preferred.

Problem Solving:
• Proactively works on problems of a moderate to 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 all resources when selecting methods and techniques for obtaining results.
• Acts independently and proactively to recommend and administer methods and procedures for problem resolution.

TRAVEL REQUIREMENTS
• N/A

PHYSICAL REQUIREMENTS:
Frequent:
• Using fingers to perform activities such as picking, pinching or typing.
• Repetitive Motions – frequent motions of the wrists, hands and/or fingers.
• Sitting for extended periods of time.

Occasional:
• Standing for extended periods of time at work station or equipment.
• Walking to move short distances quickly and frequently.
• Grasping – applying pressure to an object with the fingers and palm
• Lifting – raising objects from lower to upper and/or moving objects horizontally – up to 25 lbs.

Visual Acuity:
• Perform activities such as computer work, preparing and analyzing data, extensive reading, visual inspection involving small defects, small parts and/or operation of machines (including inspection), using measurement devices and/or assembly or fabrication of parts at a distance close to the eyes.

WORKING ENVIRONMENT:
• Occasional exposure to moderate to loud noise levels.
• Occasional exposure to moving mechanical parts or equipment.
• Occasional exposure to fumes, odors, dusts, mists, gasses or vibrations.
• May be required to wear personal protective equipment (PPE) as needed when in production areas (i.e. safety glasses, respirator, hearing protection, gloves, etc.).

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.

Maintains and manages material and production master data, by creating and/or updating master data and monitoring progress of changes through the Enterprise Resource Planning (ERP) system and/or Manufacturing Execution System (MES) and/or Master Data Governance (MDG). Accuracy in master data is a foundational business enabler to which a great deal of attention to detail and process execution robustness is mandatory. Therefore, this role establishes and implements procedures and guidelines that ensure consistency and accuracy of master data. And it provides support to business partners as an ERP, MDG or MES system expert. This position requires good interpersonal, organizational, and communication skills (both oral and written), as well as a proven track record of delivering results. It requires an understanding of pharmaceutical regulatory requirements and a basic understanding of the end to end pharmaceutical production process, including packaging and distribution to the distribution center(s).

ESSENTIAL AREAS OF RESPONSIBILITY

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or 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.
• Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
• Create new material masters and initiate changes to materials masters throughout the material lifecycle in the ERP system.
• Create and revise the Bill of Material (BOM), Recipe and Production Version (PV) in the ERP system. This includes the creation and maintenance of the Packaging Master Record (PMR) for the production of Finished Goods. It also includes all necessary coordination with MES for effectives of manufacturing records and packaging masters.
• Creates tests and maintains the MBR in the Manufacturing Execution System. It also includes all necessary coordination with ERP for effectives of manufacturing records and packaging masters.
• Initiate TrackWise change controls (CCs) and/or complete TrackWise CC tasks as assigned as it relates to the creation and maintenance of master data. Manages the CC through its lifecycle ensuring all tasks are closed on time.
• Work with MS&T to coordinate master data creation to align with project timelines and needs.
• Work with Supply Chain Planning to ensure master data readiness to support the production schedule.
• Writes/revises procedures (SOPs and Work Instructions) to support business process and technical requirements of maintaining master data.
• Cross training and support of MDG, MES and ERP will be assigned as needed.
• May be required to provide technical support to operations for MES execution.
• May be required to provide end user training for ERP, MDG and/or MES.
• May serve as a business process owner for SAP Master Data Management and/or MES.
• Responsible for performing additional related duties as assigned, such as but limited to, running reports and completing analysis to support TLMS system and team KPIs.

Qualifications

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

Education/Certification/Experience:
• A minimum Bachelor’s degree required; Supply Chain or industry related fields.
• A minimum 4 years of experience within pharmaceutical or related manufacturing facility.
• Working knowledge of QAD and TrackWise; Glorya, SAP, MDG and MES preferred.
• Has a working knowledge of theories, practices and procedures as it relates to master data and works with a moderate level guidance; Working knowledge of end-to-end material flow and basic Supply Chain principles preferred.

Skills/Knowledge/Abilities:
• Proficient in Microsoft Excel, Access, Word and Outlook.
• Skill in organizing resources and establishing priorities.
• Ability to make administrative/procedural decisions and judgments.
• Ability to create, compose, and edit written materials.
• Analyze reports and make recommendations in support of production demand

Problem Solving:
• Works on problems of moderate scope where analysis of situation or data requires knowledge and evaluation of identifiable factors.
• Exercises judgment within broadly defined practices and policies and selects methods and techniques for obtaining solutions.
• Normally receives little to moderate instruction on routine work and receives general instructions on new assignments.
• May proactively recommend methods and procedures for problem resolution.

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 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.

Embark on a future with an international pharmaceuticals company, contributing your creative energy to high-impact projects from the moment you arrive through the course of this 12-week experience. You will take part in meaningful work and real-life projects that will help you grow both professionally and personally throughout the program.

• Location: West Chester, PA
• Length: minimum of 12 weeks (TBD during mid-May through mid-August)
• Schedule: You must be available to work a 40-hour work week (onsite) for 12 weeks
• Pay: TBD

Tasks & responsibilities

• During the 12-week program, you will gain in-depth insight into the R&D Global Statistics and Data Science department and Real-World Evidence (RWE) group.
• Supported by a mentor and experienced colleagues, you will be directly involved in our daily business and be assigned tasks within diverse projects that involves applying cut-edge statistical methods and using real-world data to generate insights and evidence for better understanding diseases and improving patient outcomes.
• You will also play an important role in the development of concepts and initiatives within the RWE Statistics business unit.

• Currently enrolled in PhD program of Biostatistics, Statistics
• Fundamental understanding and experience in statistical concepts and modeling, such as regression, survival analysis, multiple imputation, machine learning, etc.
• Experience in working with RWD and/or clinical trial data preferred

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.