דרושים מהנדס אימות ב-טבע ב-United States, East Bradford 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.