Process Engineer II
Company: Alcami Corporation
Posted on: March 11, 2019
Think Different. Do Different. Be Different.
Alcami is a world-class contract development and manufacturing organization (CDMO). We are a team of dynamic individuals committed to developing life-saving drugs around the world. A mindset of innovation, accountability and customer focus inspires us to be the most efficient, safe and reliable choice for our customers and the patients they serve. In return, we offer challenging careers, accelerated professional growth and the opportunity to be part of something different.
The Process Engineer II Packaging is accountable for driving results in a fast-paced environment by providing technical support for the packaging of tablets and capsules in bottles and blisters for commercial distribution and clinical trials. The Process Engineer II in this position will provide technical assistance including but not limited to the following: transfer of new process and technologies into the company and writing appropriate documentation to support process transfer and validation activities, sourcing and qualification of equipment and components, troubleshooting current validated processes, initiate process deviations and conduct investigations. These functions will be executed following standard operating procedures, batch records in accordance with FDA and EU current Good Manufacturing Practices, and federal regulations. The person in this role will also train and mentors others in the organization. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.
* Provides technical assistance for process transfer, start-up and validation for assigned packaging projects.
* Composes process validation, cleaning validation, or process optimization protocols.
* Assists with identification, selection, sourcing, installation and qualification of packaging equipment and supporting utilities & systems. Designs and or modifies equipment and fixtures for packaging.
* Originates and executes packaging process validation, equipment cleaning verification & validation, or process optimization protocols and completes final reports.
* Follows applicable SOPs and cGMPs to perform assigned duties and tasks, including clearly and accurately document activities.
* Identifies specific process parameters, product sampling plans, and product tests used in the validation protocols of new and existing products.
* Writes validation and technical improvement reports with no approval authority.
* Provides input or originate as required Master Batch Records (MBRs) and in-process controls for products, equipment, critical process parameters, in-process tests, etc.
* Monitors packaging processes during initial production run to assess any technical process issues.
* Assists technicians in performing packaging tasks and related physical testing during the packaging operation (e.g. torque studies, cap closing force checks, seal integrity testing, etc.).
* Participates in investigations and complete CAPA assignments.
* Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
Education and Experience
* Bachelor s degree in engineering or related science based field required.
* 2-5 years of experience required; 5-8 years of experience preferred.
* Prior pharmaceutical industry and work experience in a GMP enviornment required
* Prior manufacturing or CDMO experience preferred.
* Consistently demonstrates honesty and integrity through personal example.
* Follows all safety policies and leads by example a safety first culture.
* Produces high quality work product with a focus on first time right.
* Complies with the company code of conduct and policies and regulatory standards.
Alcami Core Leadership Competencies
* Passion for customers. Understands Alcami customers. Gets to the heart of the matter. Uses that insight to provide value.
* Thinks strategically. Quickly identifies and acts on opportunities. Combines forethought with action. Understands the external and internal environment and the impact on Alcami.
* Acts decisively. Makes and acts on decisions quickly. Fosters the same in others and the courage to enhance risk-taking for the business.
* Drives performance. Holds self and others accountable. Creates an environment that enables others to perform at their best.
* Works collaboratively. Actively creates and promotes cross-boundary collaboration to achieve better results.
* Develops organization and people. Demonstrates genuine commitment to develop self and others.
* Working knowledge GMP, blister packaging processes and equipment, serialization processes required.
* Working knowledge of EU regulations preferred.
* Excellent verbal and written communications required.
* Ability to work with tools and machinery with minimal guidance.
* Ability to interact with internal stakeholders and external customers.
* Up to 5% travel required.
What We Offer You:
* Competitive salary with career advancement opportunities
* Profit sharing bonus plan
* Medical, dental and vision coverage from day one
* 401(k) with company match
* Company paid vacation, holiday and sick-leave
* Voluntary benefits including short & long term disability, life, accident, critical illness insurances
Diversity and Inclusion:
Alcami values diversity and we are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.
Keywords: Alcami Corporation, Wilmington , Process Engineer II, Engineering , Wilmington, North Carolina
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