Who we are

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

The opportunity

POSITION SUMMARY: This position is responsible for qualification/validation of equipment, facilities, cleaning and manufacturing processes consistent with cGMP requirements. This position is also responsible for providing technical expertise in the development, improvement, and troubleshooting of manufacturing equipment and processes. This position coordinates resources from Engineering, Process Development, Quality Control, Quality Assurance and Production assigned to validation/technical services projects.

 

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 writing protocols, reports, SOPs, and other formal documents consistent with cGMP requirements as related to qualification and validation activities. 
•    Responsible for executing qualification protocols for equipment, utilities, facilities, cleaning, and manufacturing processes with proper documentation as related to qualification and validation activities.
•    Responsible for assisting in the review and approval of equipment, facilities and other modifications under change control as related to qualification and validation activities.
•    Responsible for remaining current on validation practices in the pharmaceutical industry and provide expert advice on validation requirements to other Teva employees. 
•    Responsible for providing information to QA and other Teva departments on technical aspects of qualified and validated systems. 
•    Responsible for participating in the selection and qualification of new equipment.  
•    Responsible for assisting in the production of worldwide regulatory compliant documentation of validation and representing the department in meetings or inspections by regulatory authorities as needed as related to qualification activities.
•    Responsible for performing Annual and Quarterly Periodic Reviews as per Teva’s compliance schedule as related to qualification activities. 
•    Responsible for executing and maintaining all equipment, facilities, and utilities in the compliant state throughout each change and each periodic review as related to qualification activities.  Includes all summary reports and periodic review documents that must be drafted for each piece of equipment and utility.  
•    Responsible for providing technical input for the qualification and validation of manufacturing and packaging equipment as well as facilities.
•    Responsible for providing an internal technical support role in engineering by designing and executing necessary studies to support qualification and validation of equipment and facilities.
•    Responsible for assisting with due diligence assessments as Teva reviews new technologies or products. 
•    Responsible for completing all training requirements and maintaining 100% 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.
 

Your experience and qualifications

POSITION REQUIREMENTS

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

Education/Certification/Experience:
•    Requires Bachelor’s Degree in Science/Engineering and a minimum of 5 years relevant progressive experience in a cGMP 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 in validation and technical services within a pharmaceutical environment preferably with non-sterile solid dosages.

 

Skills/Knowledge/Abilities:
•    Computer proficiency with comprehensive working knowledge of MS Office products and systems such as SAP, Oracle, Trackwise and other computer relational databases.
•    Detail oriented with ability analyze information, create metrics and articulate the link to business needs/objectives.
•    Interact positively and collaborate with co-workers, management and external partners.
•    Detailed knowledge and experience with applicable qualification and validation processes. 
•    Ability to work in a team environment through conflict resolution and negotiations, influence and lead others with and/or without direct supervisory authority.
•    Self-directed with ability to organize and prioritize work. 
•    Communicate effectively with strong written and oral communication and technical writing skills.
•    Familiarity with engineering design principles as related to validation.
•    Project management skills preferred.

 

PHYSICAL REQUIREMENTS:

Occasional:
•    Walking to move short distances quickly and frequently
•    Climbing – use of feet, legs, hands and/or arms to ascend or descend (for non-office)
•    Stooping, Kneeling and/or Crouching – bending body, spine and/or legs (for non-office)
•    Twisting/Reaching – turning at waist and extending hands and/or arms in any direction
•    Grasping – applying pressure to an object with the fingers and palm
•    Repetitive Motions (frequent motions of the wrists, hands and/or fingers)
•    Lifting – raising from lower to upper and/or moving objects horizontally up to 50 lbs.

 

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, 13 paid Holidays and 3 paid floating holidays. 
•    Life and Disability Protection: Company paid Life and Disability insurance. 
•    Additional benefits include, but 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.

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

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.

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. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

 

Important notice to Employment Agencies - Please Read Carefully
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.