CharlestonRecruiter Since 2001
the smart solution for Charleston jobs

Process Engineer

Company: Alcami Corporation
Location: Charleston
Posted on: October 12, 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 I (Sterile) for our parenteral site in Charleston, SC is accountable for driving results in a fast-paced environment by providing technical support for the manufacturing facility, including, troubleshooting validated processes, process deviations and investigations, transfers of new processes and technologies into the site and preparation of documentation to support validation and process transfer activities.. 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 and validation efforts for assigned manufacturing.

* Composes process validation, cleaning validation, or process optimization protocols

* Identifies specific parameters, sampling, and tests used in the validation protocols of new and existing products.

* Writes validation and technical improvement reports with no approval authority.

* Writes Master Batch Records with a strong understanding of (equipment, critical process parameters, in-process tests, etc.).

* Monitors manufacturing processes during initial production run to assess any technical process issues.

* Assists technicians in performing physical testing during the aseptic manufacturing operation (e.g. sterilization, depyrogenation, lyophilization, and sanitization).

* Participates in investigations and complete CAPA assignments.

* Utilizes FMEA to trouble shoot processing issues.

* Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Education and Experience

* Bachelor s degree in Engineering, Pharmacy or Chemistry with 0-2 years of experience of technical support in a sterile pharmaceutical manufacturing environment.

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

* Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.

* Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.

* Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.

* Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.

* Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.

* Works collaboratively. Seeks out the experience of others with the aim for better results. Open minded regardless where ideas originate. Flexible and easy to work with.

Functional Competencies

* Knowledge of cGMP

* Some understanding of pharmaceutical manufacturing and packaging of parenterals; principles of technology transfer, process investigations, scale-up, process validation and optimization of liquid fill dosage forms; and lyophilization and sterilization would be helpful.

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.
* Back Share


Apply Now

Keywords: Alcami Corporation, Charleston , Process Engineer, Engineering , Charleston, South Carolina

Click here to apply!

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

I'm looking for
in category

Other Engineering Jobs

Description: Join Our Team Sunbelt Rentals strives to be the customer's first choice in the equipment rental industry. From pumps to scaffolding to general construction tools, we aim to be the only call needed to (more...)
Company: Sunbelt Rentals, Inc.
Location: Charleston
Posted on: 10/18/2019

Diesel Technician/Mechanic III - Entry Level
Description: br br What's the Job br Ready to accelerate your career while helping our customers move forward As a Technician III at Penske, you'll do exactly that. Here, you'll do preventative maintenance (more...)
Company: Penske
Location: Summerville
Posted on: 10/16/2019

Commercial HVAC Installation Mechanic
Description: br br Job Description br br Company: ARS/Rescue Rooter GROW WITH THE PROS ANDMASTER YOUR CAREER br br Only the best of the best work for the largest and fastest-growing leader in residential (more...)
Company: ARS Rescue Rooter
Location: Charleston
Posted on: 10/17/2019

Azure Cloud Engineer
Description: Lynker has an--opening for a--Systems Engineer--with a focus on--Microsoft Azure cloud technologies--to support NOAA's Office for Coastal Management OCM .--This is a full-time position located in--Charleston, (more...)
Company: Lynker Technologies
Location: Charleston
Posted on: 10/20/2019

Satellite Cable Technician - Charleston, SC Region
Description: Custom Communications, Inc.Supplying award-winning, mobile field service technicians for over twenty yearsCCI is one of the nation's largest providers of managed mobile field services. Over the last 20 (more...)
Company: Custom Communications, Inc.
Location: Mount Pleasant
Posted on: 10/18/2019

Experienced Automotive Technician
Description: DescriptionThe Experienced Automotive Technician is a veteran or master auto mechanic. You ll benefit from our Career Road Map training and company paid ASE Certifications. We are looking for car enthusiasts (more...)
Company: NTB
Location: Charleston
Posted on: 10/19/2019

Maintenance Mechanic
Description: Maintenance Mechanic br If you are an Industrial Maintenance Mechanic / Maintenance Technician with a well rounded industrial repair background, please read on. br br br What You Will Be Doing (more...)
Company: CyberCoders
Location: Savannah
Posted on: 10/21/2019

Full Stack MEAN Engineer
Description: Full Stack MEAN Engineer---RESPONSIBILITIESDeveloping web-based applications using the MEAN stack, including Angular, Node.js, and MongoDBCreating RESTful services with Node.jsDeploying and monitoring (more...)
Company: Palmetto---
Location: Charleston
Posted on: 10/23/2019

Maintenance Reliability Engineer - Chemical Plant
Description: MAINTENANCE RELIABILITY ENGINEERSavannah, GA-- Salary:-- 85 - 110kOur--chemicals manufacturing--client is seeking a--Maintenance Reliability Engineer--for their Engineering Department. The Maintenance (more...)
Company: Job Juncture
Location: Savannah
Posted on: 10/18/2019

Sheet Metal Mechanics - Charleston
Description: CCS Construction is now hiring HVAC/Sheet Metal Duct mechanics with commercial experience. Apply today - start right away Sheet Metal Mechanics should have at least 5 years of commercial
Company: CCS Construction Staffing
Location: Charleston
Posted on: 10/17/2019

Log In or Create An Account

Get the latest South Carolina jobs by following @recnetSC on Twitter!

Charleston RSS job feeds