Validation Engineer I
West Chester, United States, Pennsylvania, 19380
Who we are
The opportunity
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.
The position is based in West Chester, PA, and requires an on-site presence. Occasional travel to other global Teva or vendor sites may be required.
How you’ll spend your day
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
Your experience and qualifications
- 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.
Enjoy a more rewarding choice
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.
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Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.
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Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
