Easter Seals Jobs

Qualification Engineer

Date: Dec 10, 2024

Location:

Edison, United States, New Jersey, 08817

Company: Teva Pharmaceuticals

Job Id: 59536

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

The Qualification Engineer II has responsibilities for equipment and utilities qualification, commissioning, and improvement activities at the Teva Edison Site in NJ primarily and occasional projects at Teva Fairfield site in NJ. In addition to leading equipment qualification projects, the Qualification Engineer II acts as a subject matter expert (SME) for all qualifications at the Edison Site. This individual is responsible for performing and overseeing equipment, utility, and facility qualification activities, while providing technical expertise for complex engineering process improvement projects. Moreover the individual will be expected to act as a project manager for smaller equipment as well as process change projects.

How you’ll spend your day

Essential Duties / Functions

• Lead Site Expansion and Renovation activities, including Commissioning and Qualification for Facility, Utility, and Equipment systems, with minimal supervision.

• Develop and review Validation / Qualification protocols and reports that challenge the critical parameters related to installation, operation, and performance of related facility, utilities, computer systems, or equipment.

• Analyze complex datasets to ensure adherence to protocol acceptance criteria; author deviation reports and provide root cause analyses and corrective/preventative actions

• Act as a primary technical writer and reviewer for engineering turnover packages and design documentation to support qualification.

• Oversee and participate in factory acceptance testing and commissioning support, ensuring compliance with company and regulatory standards.

• Collaborate with Engineering, Operations, Supply Chain and other stake holders to facilitate efficient launch requirements needed for new products packaging, ensuring alignment with qualification and validation requirements.

• Lead the development of User Requirement Specifications (URS) and Functional Requirement Specifications (FRS) for validation-related projects.

• Execute and provide technical leadership for Engineering Studies to establish robust equipment operating parameters.

• Ensure compliance with the Site Validation Master Plan and Validation Project Plans, proactively addressing risks and gaps in qualification processes.

• Develop and manage project timelines, resource allocation, and status communication for qualification initiatives.

• Mentor and train junior team members, fostering skill development and knowledge transfer within the engineering team.

• Support regulatory inspections and audits, serving as an SME for qualification activities including the ones done in the past.

• Work in a self-directed manner and must be able to work on problems of a complex scope where in-depth evaluations of various factors is required along with managing small projects.

• Perform other duties as assigned by the Engineering management.

Your experience and qualifications

Education:

• Bachelor’s degree in engineering or equivalent on-the-job experience/training

Experience:

• 7+ years, Qualification or Engineering experience in a pharmaceutical industry, preferably in a production/packaging setting.

• In depth knowledge of qualification requirements for pharmaceutical operations including packaging, utilities, CSV, automated control systems, HVAC and equipment engineering.

• Specialized Skills / Technical Knowledge, Licenses, Certifications:

• Knowledge of Current Good Manufacturing Practices ( cGMP), Food and Drug Administration (FDA), OSHA and related federal, state and local laws, codes, regulations and regulatory requirements

• Knowledge of pharmaceutical manufacturing operations to support the approval of protocols, reports, procedures and specifications.

• Strong Understanding of Process Controls and Systems Integration preferably associated with solid oral dose / packaging equipment

• Independent, motivated individual with ability to deliver on and manage multiple projects

• Advanced troubleshooting & problem-solving skills.

• Understanding of safety and equipment procedures.

• Ability to work with heavy equipment, climb steps, lift and push objects.

• Proficient in English usage, spelling, grammar and punctuation

• Proficient at communicating clearly and concisely, both orally and in writing.

Physical Demand Requirement

Incumbents in this class are subject to extended periods of sitting, standing, walking, pushing and pulling, stooping and crouching climbing and walking, vision to monitor, occasional lifting of equipment or materials weighing up to 25 pounds. Incumbents may be exposed to toxic materials, toxic gases, electrical hazards, and dangerous tools and equipment. Work is performed in a manufacturing environment.

Enjoy a more rewarding choice

We offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance.

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 (https://performancemanager.successfactors.eu/sf/careers/jobsearch?bplte_company=1080030P)

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.

EOE including disability/veteran