Allergan Pharmaceutical Technology Scientist (Validation) in Waco, Texas
Pharmaceutical Technology Scientist (Validation)
Waco, Texas, United States at https://agn.referrals.selectminds.com/jobs/7294/other-jobs-matching/location-only
Nov 15, 2018Post Date
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.
Support the Pharmaceutical Technology department through planning and conducting the evaluation, selection, application and adaptation of engineering techniques, procedures and criteria in manufacturing processes. The position will also be responsible for optimizing manufacturing processes for new and existing products, including ingredient addition, blending, sterilization and transfer methods. This position will support manufacturing by resolving process and equipment issues and preparing drawings, specifications, calculations, charts and graphs. The position will also monitor work compliance to applicable codes, cGMP and current safety standards, accepted engineering practices and end user / or Allergan standards.
Main Areas of Responsibilities
Manage/perform site projects focused on Process Validation, process optimization, process trouble shooting and new product introduction.
Liaise with site project teams.
Evaluate project budgets, forecast, expenditures and accomplishment of objectives and ensure all projects are executed on time and within budget.
Open and close change controls for each project as necessary.
Review and approve ECR/ECO’s.
Assess the effectiveness of current projects and identify possibilities for new projects and opportunities.
Coordinates resources from Engineering, Quality Assurance, and production personnel assigned to specific projects.
Furnish direction to engineers and technicians regarding project requirements.
Develops and communicates project timelines and status.
Generation and execution of protocols for both new and marketed products including the qualification of new chemical raw materials and components.
Work with other departments to ensure identified work items are addressed in a timely and satisfactory manner.
Perform filing, computer input/output tasks and prepare identified reports as required.
Address internal and external customer queries under the guidance of the department supervisor/manager.
Assure our business practices enhance the welfare of our customers, employees and community in which we operate.
Ensure that all activities are fully compliant with all criteria established by governmental agencies, Ministries of Health and legislative requirements.
Maintain a clean and organized work area
Assist Allergan in achieving environmental, health, and safety goals by working safely and observing all general plant and department safety policies.
Perform all assigned duties according to departmental SOP’s and cGMP’s, and company policies.
Remain current on proper procedures by reviewing current, revised, and new SOP’s relating to the job and to the department.
Complete and remain current with all required cGMP and safety training.
Perform other duties as assigned.
Incumbent has full authority to make decisions and/or take actions required to carry out job duties. Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements, and objectives. The incumbent must be willing to take temporary assignments as required.
The following listed requirements need to be met at a minimum level to be considered for the job:
Minimum B.S. Engineering, statistics, or sciences degree from an accredited institution
Six (6) years of experience including process engineering experience (addition/mixing/transfer) with solutions, suspensions, gels or ointments.
Three (3) years of experience in the pharmaceutical industry preferred with Aseptic Processing experience.
One (1) year of project management experience leading projects
Project Management skills and principles.
Strong financial and cost accounting skills desired.
Knowledge and understanding of current Good Manufacturing Practices (cGMP).
Knowledge and understanding of Regulatory Compliance criteria established by Governmental Agencies, Boards of Health and Legislative Requirements, such as FDA, OSHA, EPA, and DEA.
Basic knowledge of strategic and tactical issues in an operations environment.
Detail-oriented and self-motivated.
Ability to handle multiple projects, duties, and assignments.
Ability to read, comprehend, write, and communicate effectively in English.
Ability to carry out detailed written or oral instructions.
Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment.
Knowledge and understanding of personal computer operations, including Windows-based computer systems such as Microsoft Office applications (Word, Access, Excel, PowerPoint, MS Project), with an ability to learn other computer-based systems.
Understanding of equipment qualification / calibration concepts.
Understanding of pharmaceutical raw material tests and raw material characterization.
Ability to perform intermediate statistical computations (Cp, Cpk, regression, analysis), and practical application of statistical software.
Knowledge and application of process improvement for all types of products.
Knowledge of process / cleaning validation processes.
Ability to employ sound leadership skills for providing guidance to project teams.
Ability to solve practical problems, considering a variety of concrete variables in situations where only limited standardization exists.
Equal Employment Opportunity Employer
Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.