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Process Engineer
Posting Locations Charleston, SC
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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.

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