Process Engineer (Drug Manufacturing)
Job Description
Hands-on engineering position with responsibility for developing drug manufacturing processes, selecting raw material suppliers, producing supplies for clinical trials, and writing documentation for FDA applications. Products are primarily semi-solids and liquids for topical and transdermal drug delivery, including drug/device combination products. Candidate must be self-motivated as this entry-level engineer will work under general supervision on a small team.
Essential Duties & Responsibilities
- Collaborate with formulators to develop drug product manufacturing processes in both small and large scale manufacturing environments.
- Select suppliers of raw materials and packaging suitable for pharmaceutical use and maintain specification documents.
- Collaborate with commercial manufacturing groups, including contract manufacturing organizations.
- Participate in design control activities for drug/device combination products.
- Statistical design of experiments.
- Statistical process control.
- Prepare various documents, including product specifications, manufacturing batch records, experimental protocols, technical reports, SOPs, and FDA applications.
- Coordinate, supervise, and participate in manufacturing of batches for use in clinical and stability studies.
- Work within a GMP quality system.
- Conduct investigations into manufacturing problems and implement corrective and preventive actions.
- Perform risk assessments for manufacturing processes, formulations, and device designs.
Qualifications
Qualifications
Bachelor’s degree in engineering or the sciences
Additional Requirements
- 1–2 years of experience in laboratories or other technical fields.
- Time management skills to work on multiple projects simultaneously.
- Excellent communication skills, both written and verbal.
- Strong problem solving skills, especially mechanical, chemical, and logistical.
- Good statistical skills.
- Ability to work in a manufacturing environment with hazardous materials and industrial equipment.
Company Info
Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!
Function
Manufacturing
Sub Function
Technical Transfer
Reports To
In process of validation
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.