Process Engineer III

Aktiv Pharma Group is hiring for a Process Engineer III for our facility in Ft. Collins Colorado. This position will begin in October 2022. We are a fast-growing company focused on addressing unmet medical needs through a proprietary drug delivery system.

The Process Engineer III will own drug manufacturing process development, scale-up, transfer, and commercialization activities.

At Aktiv Pharma Group, we value the diversity of perspectives and backgrounds our employees bring. We are committed to achieving a diverse workforce through application of our equal opportunity employment policy and by providing a work environment free of discrimination and harassment. We work according to our values of truth, caring, goodness and perseverance, and encourage individuals with the required skill-sets and these values to apply.

The compensation range for the Process Engineer III is $80,000 - $110,000 annually.

Aktiv Pharma Group offers a wealth of benefits to our employees and their families.

Employee Benefits Include:

• Medical Insurance (Cigna):
  • HDHP – Aktiv contributes the full monthly premium for the employee and their dependents.
  • Two additional premium medical plan options – Aktiv contributes a portion of the monthly premium for the employee and their dependents.
• Vision Insurance (Principal/ VSP Network)
  • Aktiv contributes the full monthly premium for the employee and their dependents.
• Dental Insurance (Principal)
  • Low Plan - Aktiv contributes the full monthly premium for the employee and their dependents.
  • High Plan - Aktiv contributes a portion of the monthly premium for the employee and their dependents.
• Legal & ID Shield
  • Aktiv contributes the full monthly premium for the employee and their dependents.
• Spending Accounts (Rocky Mountain Reserve)
  • FSA
  • HSA
  • DFSA
  • LP FSA
• Ancillary Benefits (Colonial Life)
  • Accident
  • Group Medical Bridge
  • Voluntary Life AD&D
  • Disability
• 401k (Human Interest)
• Unlimited Paid Time Off
• Bi-Monthly Internet and Cell Phone stipend
• Fully Paid Membership for the employee and their dependents to Lifetime Fitness
• Fully stocked office kitchen – Health conscious and Vegan!
• Remote Work Options

Essential Duties/Responsibilities

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Develop registration and commercial size drug manufacturing processes for identified lab scale processes
• Source, install, and qualify process equipment
• Write batch records, work instructions, and other supporting documentation for manufacturing processes
• Run engineering batches, coordinate batch testing, and evaluate results to determine next steps
• Write risk assessments and pFMEAs to support the developed process
• Complete product specific technical investigation to determine root cause and identify appropriate CAPAs
• Write/support process development sections of regulatory fillings
• Own process validation activities
• Train manufacturing personnel on equipment and processes to support successful hand-off of commercial processes

Job Qualifications

Competencies, Knowledge, Skills, and Abilities:

• Pharmaceutical experience and excellent knowledge of current Good Manufacturing Practices (cGMP) required
• Lyophilization experience preferred
• Autoclave experience preferred
• Aseptic process knowledge preferred
• Excellent oral and written communication skills
• Skill involving diverse and challenging problems
• Ability to manage multiple projects concurrently and under tight time constraints

Education or Formal Training:

• Bachelor’s degree in science or engineering field preferred

Experience:

• Minimum 4 years industry experience including related industries

Additional Requirements/Licenses/Certifications:

• Must have reliable transportation
• Valid driver’s license

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