Process Engineer

Sun Pharmaceuticals, Inc; New Jersey; On-site; USD 101,000 - 113,000; Full time

Benefits offered by this job

Medical, dental, vision

Life insurance

Disability insurance

401(k)

Flexible spending accounts

Employee assistance program

Paid time off

Job summary

Sun Pharmaceuticals, Inc is seeking an engineering professional to design and optimize manufacturing processes and introduce cost-effective technologies for API production.

The role requires a BS in Chemical Engineering with 5+ years in FDA/GMP environments, strong organizational and presentation skills, and the ability to manage projects on time and within budget. Base compensation is 101k–112.5k with bonus eligibility.

Qualifications

• BS in Chemical Engineering is required.
• At least 5 years of experience with FDA/GMP in pharmaceutical manufacturing.
• Excellent organization skills required.
• Ability to present ideas effectively to all levels of management.

Responsibilities

• Prepare, review, approve and distribute production instructions for intermediates or APIs.
• Produce APIs and intermediates according to preapproved instructions.
• Review production batch records for completeness and signatures.
• Investigate and document production deviations and corrective actions.
• Ensure facilities are clean, disinfected and maintained records.
• Ensure calibration records are kept and performed as scheduled.
• Review and approve validation protocols and reports.

Skills

FDA/GMP experience

Organization skills

Presentation skills

Education

BS in Chemical Engineering

Job description

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.

Compensation & Benefits

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.

Equal Employment Opportunities

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.