Performance Engineer jobs in United States, Pennsylvania, Newtown 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 this role, you will be responsible for managing the day-to-day operations of the Packaging and Performance (P&P) testing group and initiatives. Supervise the team to assure safety and conformity with processes and procedures to reduce risks and improve compliance and productivity. Monitor and achieve team metrics, provide direction to analysts, and manage their performance.

• Supervise the day to day activities of the P&P team and act as mentor.
• Preparation and reporting of KPI’s
• Knowledge and understanding of the following P&P test techniques and capabilities:
  • Sample/Device Performance testing (ISO 11040 and 11608, etc.), Compendial testing (USP 381 and382), Force analysis, CAD and 3D design, Lab Scale Filling and Assembly, Method development and validation
• Assist 2nd Shift, CCI and P&P Manager with management and allocation of resources and assignments
• Assure that analysts have been adequately trained for their role.
• Review and release final reporting to internal and external customers as it pertains to the group. Communicate updates for all projects timely
• Follow required cGMP regulations and assure compliance per internal QA procedures
• Supervise and approve laboratory quality investigations to support internal and external customers
• Manage the development and validation of numerous analytical techniques
• Implement continuous improvement/lean activities and events for the group
• Write, review, and approve documents (Investigations, Work Instructions, SOP’s, etc.)
• Support internal and external audits as required
• Hire new employees ensuring that their qualification and skills set fit with the needs of the individual role
• Independently drive projects from initiation through completion
• Lead communication with internal and external customers
• Provide direction to his/her group and assist in providing systems and direction to control costs, reduce risks and improve productivity
• Assure Safety procedures are followed and identify any safety risks with preventative action
• Maintain cognizance of current validation requirements.
• Work independently and as part of a team with self-motivation, adaptability, and a positive attitude
• Other duties as assigned

• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Position operates in a professional office environment. May stand or sit for extended periods of time
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read & write, speak in front of groups, express & exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of related activities
• Read and interpret data, information and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems

• Bachelor’s degree in Chemistry, Mechanical Engineering or equivalent experience

• Minimum 6 years of experience in laboratory environment
• Minimum 1-3 years of personnel management or project management

• cGMP
• ISO and USP/EP compendia, Specifically ISO 11040, 11608, and USP 381, 382. Basic statistical understanding
• Understanding of CAD Design, 3D Printing, Minitab, Zwick, Instron or Solidworks/ Solidworks PDM
• Strong oral and written communication skills and attention to detail required
• Awareness to relevant Company policies as they are related to the position covered by this Job Description
• Experience with Instron, Zwick, Benchtop Assembly Instrumentation, Medical Device EDDO’s, and Method Development and Validation strategies
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times.

• Job-related activities that require a physical activity such as standing in laboratory environment
  • Use hands to finger, handle, feel or operate objects, tools or controls and reach with hands and arms.
  • Employee may be required to lift heavy objects (up to 25 lbs.) without assistance
• Job-related activities that require a mental skill or ability such as communication, quick decision making, interpreting data, reading or writing, public speaking, etc. (e.g., Must be able to express or exchange ideas with employees; Must be able to understand direction and adhere to established procedures)