Project Compliance Engineer - SLC West

Who we are

The opportunity

This position responsible for development, creation and management of GMP documents (change controls and child tasks, SOPs, PMs, periodic reviews, qualification protocols/reports in support of Engineering and Maintenance). This role will ensure that all documents and activities are managed to completion by their assigned dates, and otherwise updated, trained, and effective in alignment with the department needs. This position will support multi-disciplined teams in the development of GEL documents for equipment acquisition and the installation/implementation process. The acquisition responsibility includes but is not limited to the creation of CERs in Planisware and their funding through SAP. This position will also support Engineering and Maintenance with the requisite documentation for making equipment and process changes to increase efficiency and capacity.

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.

· Responsible for developing project timelines based on input from end users as well as suppliers, then manages projects to meet established schedules.

· Responsible for interfacing with relevant stakeholders/departments to lead the installation and qualification of new equipment and upgrades to existing equipment.

· Responsible for creation and execution of “procurement only” site projects.

· Responsible for assisting relevant stakeholders/departments in the development of new production areas.

· Responsible for contributing to Qualification Protocols, SOPs and PMs in support of all new equipment and production processes.

· Responsible for performing and/or supporting the qualification of new and modified equipment.

· Responsible for writing and execution of change controls for new and existing equipment.

· Responsible for directing or overseeing the work of project team members and junior personnel as needed.

· Responsible for completing all training requirements and maintaining 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

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 7 years relevant progressive experience, preferably in a manufacturing environment within pharmaceutical, medical device or nutraceutical industries.

· Requires extensive knowledge and experience in change control processes.

· Requires extensive knowledge and experience in electronic document management systems.

· Requires experience in project management.

Skills/Knowledge/Abilities:

· Computer proficiency with comprehensive working knowledge of MS Office products and systems such as SAP, Veeva, EDMS, 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 change control and 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.

· Subject matter expert on tablet compression equipment and process.

Problem Solving:

· Proactively works on problems of a moderate to complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.

· Seeks out all resources when selecting methods and techniques for obtaining results.

· Acts independently and proactively to recommend and administer methods and procedures for problem resolution.

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 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.