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Process Engineer

Manufacturing Center Morrisville, NC | Full Time
16 Days Ago

Job Description

Position Summary

The Process Engineer in Technical Services is accountable for driving results in a fast-paced environment by providing technical support for Drug Product Development of products filled into vials and syringes. Projects range from Phase I clinical supplies to commercial supplies.  This role will be responsible for ensuring clients have the best technical and engineering solutions for their products as it relates to the manufacturing process.  The Process Engineer in this position will provide technical assistance including but not limited to the following: transfer of new process and technologies into the company, authoring appropriate documentation to support process transfer, sourcing of equipment and components, designing new disposable process flows, troubleshooting current validated processes, contribute to process deviations, and conduct investigations. The role is expected to support client projects by technical transfer of projects into GMP manufacturing, assuring regulatory compliance, and ensures standard operating procedures are understood and followed. This role must have working knowledge with tech transfer, scale-up, scale-down, equipment qualifications, process development, process improvements, process validations, and clinical manufacturing.  In addition, this role must have working knowledge of QbD and risk assessments. These functions will be executed 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 process validation for assigned sterile products.
  • Evaluate that processes are safe, reproducible, cost effective, environmentally sound, and can be successfully validated and transferred to commercial production
  • Provides client support in new and novel technologies and therapies
  • Composes process validation, cleaning validation, or process optimization protocols.
  • Demonstrates technical understanding of sterile operations including aseptic fill, terminal sterilization, and lyophilization.
  • Manages batch records, prepares technical summary reports, processes qualification, and material specifications for new disposable items.
  • Manages risk-based life cycle.
  • Prepares and carries out presentations related to the Company or project information.
  • Ensures that deliverables are met or expectations are proactively managed towards alternative solutions.
  • Assists with identification, selection, sourcing, design, and specification generation of disposable materials used for manufacturing of bulk drug products
  • Originates and executes filling 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
  • Originate Master Batch Records (MBRs) and in-process controls for products, equipment, critical process parameters, in-process tests, etc.
  • Monitors compounding and filling processes during initial production run to assess any technical process issues.
  • 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 and 7 years of related experience required or Master’s degree and 5 years of related experience or PhD in Pharmaceutics or related field and 3 years experience.
  • Experience as it relates below:
    • Sterile drug product manufacturing experience in the CDMO/CMO industry.
    • Technology transfer process.
    • Product transfer and product management
    • Process validation of drug products
    • Familar in single use system, and current procesing technologies
    • Familiar with large molecule drugs and filling of the these products
    • Managing batch records, preparing protocols and reports, process qualification and equipment configuration reporting.
    • Customer interaction and presentation of technical recommendations.
    • Defense of regulatory processes to appropriate regulatory agencies ie FDA, EU, etc.

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 GMP, sterile filling processes and equipment, lyophilization experience a plus.
  • Demonstrated knowledge and hands-on experience in the area of responsibility.
  • Excellent understanding of the theoretical background/fundamentals of the work.
  • Advanced problem-solving capabilities.
  • Consistent attention to details.
  • Excellent time management skills.
  • Excellent organizational skills.
  • Ability to multitask.
  • Computer proficient.
  • Working knowledge of EU regulations preferred.
  • Excellent verbal and written communications required.
  • Ability to interact with internal stakeholders and external customers.

Decision Making and Supervision Required

  • Uses professional concepts and company policies and SOPs to solve a variety of problems.
  • Determines methods and procedures, including new assignments and the work of others.

Travel Requirements

  • Up to 5% travel required.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk or hear; use hands to finger, handle or feel.  The employee is occasionally required climb or balance and stoop, kneel, crouch, or crawl; reach with arms and hands.  The employee must regularly lift and/or move up to 25 pounds, and some of the time move up to 50 pounds. While performing the duties of this job, the employee frequently works near moving mechanical parts, occasionally is exposed too fumes or airborne particles; risks of electrical shock or vibrations.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. 

Skills for Process Engineer

The job skills required for Process Engineer include Process Improvement, Problem Solving, Leadership, Presentation, Troubleshooting,and Commitment etc. Having related job skills and expertise will give you an advantage when applying to be a Process Engineer. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Process Engineer. Select any job title you are interested in and start to search job requirements.

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Career Path for Process Engineer

The following is the career advancement route for Process Engineer positions, which can be used as a reference in future career path planning. As a Process Engineer, it can be promoted into senior positions as a Chemical Process Engineer III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Process Engineer. You can explore the career advancement for a Process Engineer below and select your interested title to get hiring information.