WilmingtonRecruiter
the smart solution for Wilmington jobs

Process Engineer II

Company: Alcami Corporation
Location: Wilmington
Posted on: March 11, 2019

Job Description:

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.

Position Summary

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.



Essential Functions

* 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.



Alcami Non-Negotiables

* 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.



Functional Competencies

* 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.



Travel Requirements

* 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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Engineering Jobs


Mechanic
Description: compensation: up to 20 an hour Mechanic needed in an automotive
Company: Jovan's Mobile Lube
Location: Fayetteville
Posted on: 03/11/2019

Technical Writer
Description: A Technical Writer job in Wilmington, North Carolina is currently available through Belcan. To be considered for this role you will have experience in technical writing in a nuclear business environment, (more...)
Company: Belcan Corporation
Location: Wilmington
Posted on: 03/18/2019

Boat Technicians/ Mechanics
Description: Located on the Intracoastal Waterway, our boat sales and service dealership is looking for self-motivated, reliable,
Company: BellHart Marine Services LLC
Location: Wilmington
Posted on: 03/23/2019


Process Engineer II
Description: Think Different. Do Different. Be Different. br br Alcami is a world-class contract development and manufacturing organization CDMO . We are a team of dynamic individuals committed to developing (more...)
Company: Alcami Corporation
Location: Wilmington
Posted on: 03/11/2019

Diesel Mechanic, Dispatcher
Description: Pro Transport Leasing, St. Pauls, NC
Company: Fayetteville, NC Area Jobs
Location: Fayetteville
Posted on: 03/15/2019

Process Engineer
Description: When you join us at Thermo Fisher Scientific, you'll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of 22 billion and the largest investment in RD (more...)
Company: Thermo Fisher Scientific
Location: Greenville
Posted on: 03/14/2019

Healthcare Engineer
Description: A reputable Hospital located in North Carolina is actively searching for a BuildingElectricalorMechanical Engineer for their Plant Engineering Department. This is a great opportunity to work with an amazing (more...)
Company: Clinical Management Consultants
Location: Jacksonville
Posted on: 03/18/2019

Transmission Technician / Truck Mechanic (Diesel Mechanic)
Description: Transmission Technician / Truck Mechanic Diesel Mechanic mechanic service trucks dealer Allison Transmission Technician / MechanicMon-Fri, 8am-5pm HIRING BONUS To learn more about this position (more...)
Company: Clarke Power Services
Location: Wilmington
Posted on: 03/11/2019

Motor Vehicle Mechanic - Group Lead (3rd SFG)
Description: Motor Vehicle Mechanic - Group Lead 3rd SFG Description ATS, LLC, A wholly owned subsidiary of Akima LLC , has an immediate opening for a Lead Motor Vehicle Mechanic that will require (more...)
Company: NANA Regional Corporation
Location: Fayetteville
Posted on: 03/14/2019

Technician Apprentice
Description: Location: Wilmington, North Carolina Summary: In a learning capacity the Apprentice Technician assists the Service Technician with identifying necessary vehicle service and performing the repair, service, (more...)
Company: Hendrick Automotive Group
Location: Wilmington
Posted on: 03/13/2019

Log In or Create An Account

Get the latest North Carolina jobs by following @recnetNC on Twitter!

Wilmington RSS job feeds