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Process Engineer II

3 months ago

Charles City, United States Cambrex High Point Full time

Company Information

You Matter to Cambrex.

Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients. Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.

Your Work Matters.

At Cambrex, we strive to build a culture where all colleagues have the opportunity to:

+ engage in work that matters to our customers and the patients they serve

+ learn new skills and enjoy new experiences in an engaging and safe environment

+ strengthen connections with coworkers and the community

Were committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more

Your Future Matters.

Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today

Job Overview

The P rocess Engineer I I will be responsible for implementation of projects for the manufacture of APIs and bulk intermediates and other products from development through piloting and/or commercial production.

Responsibilities

+ Writing batch records, cleaning records, SOPs, campaign reports, supplements, and investigation /deviation reports with minimal oversight to support production operations

+ Identifying and m onitoring KPIs and using process data to identify and execute improvements to new and existing products to achieve improved yields, quality or customer expectations

+ I dentify ing and executing Kaizen events with support from Process Improvement

+ Providing training and process support to production areas including training on new processes and on-site oversight of key processing steps

+ Working in a team environment that includes cross-departmental participation from Engineering, Research and Development, Regulatory, Quality Control, Analytical Development and Operations

+ Developing plans for production of pilot and commercial volumes of product

+ Developing and maintaining IQ, OQ and PQ documents and protocols with minimal oversight

+ Leading efforts to t roubleshoot and investigat e process problems and deviations with minimal guidance , and preparing appropriate reports on findings

+ Participating in HAZOPs and providing guidance on corrective actions when needed

+ Providing PFD and P&ID generation, energy balances, material balances, environmental calculations and other calculations and formulations as needed

+ Working with appropriate departments to set up codes, label requests, and MSDS revisions

+ Completing CAPAs and audit action items as assigned

Qualifications/Skills

+ Knowledge of and/or direct experience in a cGMP environment is preferred

+ General knowledge of chemical operations equipment and manufacturing operations

+ Proficient in windows based environment including word processing, spreadsheet and data base programs

Education, Experience & Licensing Requirements

BS in Chemical Engineering, plus 3 7 years or more of experience in manufacturing environment, preferably in pharmaceutical manufacture; or equivalent education/experience

Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration.

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.