דרושים Process Engineer ב-United States, Pennsylvania, Brown Township

· Perform physical testing of drug delivery devices (e.g., injection force, injection time, dose accuracy) using lab equipment such as Instron or Zwick systems.

· Set up, execute, and document testing activities in accordance with protocols and Good Documentation Practices (GDP).

· Support the development, verification, and validation of test methods under the guidance of senior engineers.

· Assist in the evaluation of device components (e.g., stoppers, barrels, springs) for fit, function, and quality.

· Participate in basic root cause investigations of product or test method deviations.

· Contribute to technical reports, data summaries, and documentation for design verification and regulatory submissions.

· Collaborate with cross-functional teams including QA, Regulatory, and Manufacturing to support development activities.

· Learn and apply relevant quality and regulatory standards (e.g., ISO 13485, ISO 14971, 21 CFR Part 820) in daily work.

Required Qualifications

· BS in Mechanical Engineering, Biomedical Engineering or a related field

· 0-2 years Medical Device or Combination Product experience

· Strong academic foundation in engineering principles and an interest in medical device or drug delivery systems including a good foundation in solid mechanics, mechanical design and fluid dynamics..

· Some hands-on lab experience (academic, co-op, or internship) with physical testing or mechanical systems.

· Ability to follow protocols and standard operating procedures.

· Effective written and verbal communication skills.

· Eagerness to learn in a collaborative and regulated environment.

Preferred Qualifications:

· Internship or cooperative experience in the pharmaceutical, biotech, or medical device industry.

· Exposure to regulated environments or quality systems (e.g., ISO 13485, GMP).

· Familiarity with Microsoft Excel, basic statistical tools, or mechanical test instruments.

· Experience in mathematical modeling and finite element analysis

· Experience in statistical analysis for medical devices

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

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 Validation Engineer I role is responsible for assisting in the timely development, execution and approval of all validation programs and lifecycle documentation, e.g. SOPs, Change Controls, CAPAs, Deviations, ensuring compliance with in-house specifications, standards and procedures, and implementing industry best practices.

This role will execute validation activities to ensure completion of projects per schedule requirements

The selected individual will be a key member of the R&D organization that owns and operates several cGxP laboratories and a manufacturing facility located at the West Chester campus.

Essential Duties & Responsibilities:

• Support all aspects of the Validation Life Cycle from design through operation and retirement.
• Responsible for authoring and execution of site Validation documentation (i.e. qualification protocols, summary reports, risk assessments, and periodic reviews)
• Perform temperature mapping studies for controlled temperature units (refrigerators, freezers, stability chambers, and walk-ins)
• Ensure vendor protocols are complete and accurate, assist vendor with issue resolution and validation deviation reporting
• Support revalidation program
• Represent Validation in multi-disciplinary teams focused on production and laboratory equipment and activities (i.e. commissioning, validation, and computerized system validation)
• Create and update Validation standard operating procedures
• Contribute to site alignment with corporate standards and cGMP guidelines
• Technically independent and maintains up-to-date knowledge of Validation standards and regulatory compliance requirements
• Work with subject matter experts to implement and/optimize key validation and quality initiatives at Teva Biologics
• Work with QA/Manufacturing group members to initiate Deviations and implement corrective and preventive actions
• Support internal and external audits and assessments
• Support continuous improvement projects and activities
• Ensure training is up to date

• BS or equivalent combination of education and experience in life science or engineering

PREFERRED QUALIFICATIONS:

• Knowledge of validation and quality compliance (cGMP/ICH/FDA/USP/EP policies/guidelines)
• Validation experience with production equipment, support equipment, HVAC and other utilities, analytical lab equipment, computerized systems/automation, CIP, and cleaning verification
• Cooperative, independent, critical thinking, multi-tasking and detail oriented
• Excellent oral and written communication skills
• Validation experience in Biopharmaceutical products or combination of Validation and Engineering/Commissioning experience.

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.

• Use technical expertise to identify system, network, and application vulnerabilities, adjusting designs based on new threat data.
• Collaborate with Infrastructure and Application teams for security reviews, vulnerability assessments, and remediation.
Support the implementation of Next Generation WAN/LAN architecture across the enterprise.Configure, implement, document, and manage security tools including Network Security, Cloud Security, End-Point Security, SIEM, DLP, Email, and security awareness training.
• Conduct automated/manual vulnerability assessments and penetration testing, collaborating with teams on remediation.
• Work closely with SOC/NOC to meet performance indicators and mitigate threats/vulnerabilities, including Security Incident & Event Management and daily threat analysis.
• Monitor systems to enhance network performance.
Troubleshoot, resolve, and communicate networking issues to employees and management.Assist with disaster recovery procedures and test plans.Diagnose and resolve hardware, software, and other network/system issues, replacing faulty hardware as needed.
• Provide system support and maintenance per standards, Network and Cybersecurity Service Delivery model, West policies, procedures, and regulatory requirements.
• Help create and maintain system lifecycle documents including Policies, SOPs, and SOIs per West policies and procedures.

• Bachelor’s degree, Diploma or equivalent experience

• 8-15 years of relevant experience

Proficiency with security products such as firewalls, URL filtering, and virus protection.Deep understanding of network infrastructure and security, including SD-WAN, routing, firewalls, and cloud networking.
• Strong focus on providing cost-effective security solutions while staying updated on security threats.
• Exceptional communication skills to translate IT concepts for non-technical audiences.
• Experience with Linux/Windows operating systems, coding languages, and networking basics like switches and routers.
Familiarity with Microsoft Azure, Cisco Networking, Fortinet SD-WAN, and security tools like IDS/IPS and encryption.
• Ability to work globally in a virtual environment, managing multiple priorities with flexibility.
• Proactive work ethic, effective prioritization in high-pressure situations, and adherence to relevant company SOPs.

In your journey with us, your prime responsibilities are:

Operations Management - Responsible for all aspects of day-to-day operations of the team aligned to him / her with respect to (but not limited to) call handling, response and resolution, introduction of new services, workload monitoring and management, performance against service level targets, quality control, call handling, training, education, knowledge management, escalations and continual service improvement

• People and Team Management
• Lead, Coach & mentor a team consisting of Agents & Subject Matter Expert(s)
• Provide monthly feedback on performance to team members
• Provide feedback to the team members with respect to any concerns or improvement opportunities
• Operations Management
• Responsible for maintaining desired level / score(s) & enhancing End User Customer Satisfaction score, Agents’ Quality Tele - Monitoring score(s) and Agents’ Communication skills / score
• Provide hands-on assistance, share information proactively and troubleshoot for your team in case of problems, both, through direct intervention and mentoring and effectively delegate responsibility.
• Ensure quality reporting and work with Operations Manager to build a highly effective measurement and reward systems based on empirical data.
• Controls and Compliance
• Ensure team’s activities conform to controls and the operation is audit ready
• Drive audit readiness of the entire service delivery operation

• Strong understanding of ITIL (IT Infrastructure Library) foundation, Six Sigma & Agile practices
• Six Sigma Green Belt trained (preferably certified)
• Knowledge of Quality Tools, Systems and Processes
• Expert working knowledge on Microsoft Applications - PowerPoint, Excel, MS-Project
• Basic Knowledge on MS-Outlook and MS-Exchange, Networking (VPN/Connectivity Issues), Internet Security, Windows, Mac O/s (Basics), Android, iOS, MS-Teams, Webex, Slack, O365
• Experience with ServiceNow or similar Incident Management Tool
• Experience and Knowledge of Staffing and Scheduling tool(s) like Avaya Workforce Optimization Suite
• Experience with working in a pharma / Biotech / GxP environment is preferred
• Bachelor’s Degree in computer science, Engineering, or related discipline with an IT certificate / diploma
• Quality Certification will be considered as an advantage
• 3+ years' experience as a First Line Manager of ~20 direct reportees, managing a technical service desk team; minimum service desk experience of 8 to 12 years
• Managed teams working in global operations and in 7/24/365 shifts
• 8 to 12 years’ experience in service desk operations
• Extensive experience in service desk operation dealing with complex technology products and services
• Strong communication (verbal and written), presentation and influencing skills
• Problem Determination & analysis skills
• Multi-cultural team management
• Stakeholder management

Dir IT Operations IT Service Operations

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.