Process Engineer

Summary:

This position will provide engineering designs and recommendations for assigned processes and new technologies to develop the most cost effective solutions for manufacturing.

Job Duties:

1. Prepare, review, approve and distribute the instructions for the production of intermediates or APIs, according to written procedures.

2. Produce APIs and intermediates according to preapproved instructions;

3. Review all production batch records and ensure that these are completed and signed.

4. Report and evaluate all production deviations and ensure that all critical deviations are investigated (with the conclusions recorded).

5. Ensure that production facilities are clean and disinfected;

6. Ensure that all necessary calibrations are performed (with records kept)

7. Maintain the premises and equipment (with records kept).

8. Ensure that validation protocols and reports are reviewed and approved;

9. Evaluate proposed changes in product, process or equipment.

10. Responsible for ensuring that new and modified facilities and equipment are qualified.

11. Review and analyze manufacturing needs, formulate solutions and implement changes to optimize manufacturing processes.

12. Manage assigned projects in order to complete each project on time, under budget and within the design parameters.

13. Provide training for API processes.

14. Other duties as assigned.

Education, Experience & Competencies

1. BS in Chemical Engineering.

2. 5 years experience with FDA/GMP. Experience with DEA guidelines and regulations a plus.

3. Excellent organization skills.

4. Ability to present ideas effectively to all levels of management.

The presently-anticipated base compensation pay range for this position is $101,000 to $112,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.