Company: Alcami Corporation
Posted on: October 12, 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
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.
* Provides technical assistance for process transfer and validation
efforts for assigned manufacturing.
* Composes process validation, cleaning validation, or process
* Identifies specific parameters, sampling, and tests used in the
validation protocols of new and existing products.
* Writes validation and technical improvement reports with no
* Writes Master Batch Records with a strong understanding of
(equipment, critical process parameters, in-process tests,
* 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.
* Consistently demonstrates honesty and integrity through personal
* Follows all safety policies and leads by example a safety first
* Produces high quality work product with a focus on first time
* Complies with the company code of conduct and policies and
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
* 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
* 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
* Passion for customers. Listens to understand. Asks the right
questions. Gets to the heart of the matter and uses that insight to
* 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.
* 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.
* 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.
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Keywords: Alcami Corporation, Charleston , Process Engineer, Engineering , Charleston, South Carolina
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