Process Engineer I - Charles City, United States - Cambrex High Point

Cambrex High Point Charles City, United States

2 weeks ago

Description

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 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 as needed to support production operations

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

+ Working with process improvement to identify and execute Kaizen events

+ 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

+ Troubleshooting, investigating process problems and deviations, 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

All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned.

Qualifications/Skills

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

+ General knowledge of chemical operations equipment and manufacturing operations

Education, Experience & Licensing Requirements

BS in Chemical Engineering, plus 1 3 years of experience in manufacturing environment, preferably in pharmaceutical manufacture; or equivalent education/experience

Ability to lift and move items up to 25 pounds.

Must be able to perform tasks requiring physical mobility, including standing for long periods, bending, and reaching.

Exposure to chemicals, moving parts, vibration, and noise within a manufacturing setting.

May require occasional travel for training or method transfer activities.

Flexible to work different shifts if necessary to meet critical deadlines

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.

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