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Process Engineer I
Posting Locations Wilmington, NC
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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/II is accountable for driving results in a fast-paced environment by providing technical support for the of tablets and capsules for commercial distribution and clinical use.  The Process Engineer I/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 manufacturing projects.
  • Composes process validation, cleaning validation, or process optimization protocols.
  • Assists with identification, selection, sourcing, installation and qualification of equipment and supporting utilities & systems.
  • Originates and executes 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). with appropriate guidance and in-process controls for products, 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 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.
  • Utilizes FMEA to trouble shoot processing issues.
  • Monitors manufacturing processes during production to assess any technical process issues.
  • Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Education and Experience

  • Bachelor’s degree in engineering, Pharmacy, Chemistry or a related science based field required.
  • 0-2 years (Eng I) or 2-4 years (Eng II) of experience required; 3-5 years of experience preferred.
  • Prior pharmaceutical industry and work experience in a GMP environment preferred.
  • 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

  • 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. Step outside your comfort zone.
  • 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

  • Working knowledge of cGMP, engineering, pharmaceutical manufacturing and packaging of EU regulations preferred.
  • Excellent verbal and written communications required.
  • Ability to effectively manage multiple priorities.
  • Proficiency with Microsoft office products (i.e. Word, Excel)
  • 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.

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