What are the responsibilities and job description for the Validation Engineer position at Teva Pharmaceuticals?

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.

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