Sr. Process Engineer
Charleston, SC 
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Posted 12 days ago
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 Senior Process Engineer (Sterile) for our parenteral site in Charleston, SC is accountable for driving results in a fast-paced environment by providing provide operational support to key process service areas (equipment/systems) in the manufacturing of commercial and clinical products at Alcami MA sites. Project engineering activities associated with technology transfers (feasibility, facility fit assessment, user requirements, process description, change control ownership, commissioning test plans, training). The Senior Process Engineer will be part of a dynamic group of engineers who will be responsible for trouble shooting, determining root cause of problems and providing process optimization strategies and process support within multi-product, FDA regulated cGMP facilities. All system improvements will be made in conjunction with Manufacturing, Facilities, Manufacturing Technical Services, Quality Assurance, Validation and Regulatory. 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 manufacturing operation (e.g compounding of product).
  • Participates in investigations and complete CAPA assignments.
  • Utilizes FMEA aid in the development of a control strategy.
  • Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
  • Keeps abreast of advancement in new technologies
  • Provides peer review for deviations/investigations.
  • Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Education and Experience

  • Minimum Bachelor's degree in Engineering, Pharmacy or Chemistry with at least 5 years experience or Master's degree with minimum 3 years experience of technical support in a sterile pharmaceutical manufacturing environment 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.
  • 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, blister packaging processes and equipment, serialization processes required.
  • Working knowledge of EU regulations preferred.
  • Excellent verbal and written communications required.
  • Ability to work with tools and machinery with minimal guidance.
  • 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 and work environment 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 regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places, risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to: safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. Other tasks involving elevated work may require the use of a body harness and lanyard. Additionally, the employee may be required to operate an industrial vehicle.

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.

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.

What We Offer You:

* Competitive salary with career advancement opportunities
* 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, sexual orientation, 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.

As part of our effort to provide and maintain a safe and healthful workplace, Alcami Corporation requires new hires to be fully vaccinated against COVID-19. Individuals are considered fully vaccinated 2 weeks after their second dose of the Pfizer or Moderna vaccine, or 2 weeks after a single-dose of the Johnson & Johnson vaccine. Individuals seeking an exemption from this requirement for medical or religious reasons should contact HR to complete a request for accommodation form.

 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
5+ years
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