Qualification Engineer II
Davie, United States, Florida, 33314
Who we are
The opportunity
Under general supervision, the Qualification Engineer II performs advanced journey-level duties in reviewing specifications and determining the critical aspects of facilities, utilities and computer systems, and manufacturing equipment with regard to product and process quality; prepares qualification protocols; performs technical and specialized engineering duties. Perform and/or provide support to validate equipment for the use in manufacturing and packaging processes. Good interpersonal, organizational, and communication skills (both oral and written) and demonstrated skills leading and working with teams to deliver projects. Introduces, troubleshoots and audits current processes. Has in-depth understanding of pharmacological, chemical, medical, compliance, legal, and industry factors.
As an exception to Teva’s 5 day internal posting policy, this role will be posted for 3 days on our internal career site.
How you’ll spend your day
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.
• Carries out responsibilities in accordance with the organization’s policies, procedures, and state, Federal and local laws.
• Reviews electrical, mechanical, and software/computer specifications in manufacturer and blue print form, and identifies critical parameters.
• Writes protocols (IQ/OQ/PQ) that challenge the critical parameters related to installation, operation, and performance of the related facility, utilities, computer systems, or equipment.
• Assures that protocols are approved through proper channels; writes and revises validation protocols.
• Executes validation and qualification protocols per related SOPs and assures that acceptance criterion related to validation and qualification protocols are met.
• Assures that all test data is gathered and recorded in accordance with cGMP requirements.
• Writes final reports and assures that they are approved through proper channels.ps and communicates
• Develops and communicate project timelines and status.
• Complies with all GMP and safety requirements, SOP’s and Company policies and procedures.
• Performs related duties as assigned.
• Performs periodic reviews of equipment and system qualifications, prepares summary report, and assigns CAPAs to address deficiencies. Includes reviews of change controls, deviations, work orders, IQ/OQ, URS, drawings, and FS/DS as applicable.
• Receives instruction, guidance and direction from others.
Your experience and qualifications
Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.
Education/Certification/Experience:
• Bachelor’s in Engineering required (Chemical or Mechanical preferred)
• at least 2 years of experience within pharmaceutical or related manufacturing facility
• Prefer previous experience in a manufacturing environment within pharmaceutical, nutraceutical or food processing industries.
• Experience in development and execution of qualification protocol/reports as related to automated equipment/systems preferred.
Skills/Knowledge/Abilities:
• Concise and organized writing of technical data
• Works with multiple departments to gather and summarize findings
• Understands manufacturing equipment functional parts including control systems, mechanical components, and electrical power.
• Related experience from other industries considered
• Responding to common inquiries or complaints from internal customers, regulatory agencies and management.
• Interpreting software changes, diagrams and flowcharts, design drawings (blue prints) and/or construction drawings and specifications including but not limited to HVAC, CA, Water Systems.
• Communicating clearly and concisely, both orally and in writing.
• Strong technical writing skills.
• Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and related federal, state and local laws codes, regulations and regulatory requirements.
• Pharmaceutical principles, practices and applications.
• Principles and practices of qualification and validation.
• Techniques and principles of sampling, testing and measuring of mathematical calculations.
• Mechanical and electrical concepts.
• English usage, spelling, grammar and punctuation
• Personal computer operations and Microsoft applications (Word, Access, excel, Powerpoint, Projects and Visio).
• Ensuring compliance with all company policies and procedures, including safety rules and regulations.
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.
Additional benefits include, but are 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.
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.
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. Request a reasonable accommodation by sending an email to disabilityassistance@tevapharm.com with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address.
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.
