Process Engineer III

Aktiv Pharma Group (‘Aktiv’) is a fast-growing, vertically integrated specialty pharmaceutical company with combination products CDMO capabilities, developing, manufacturing, and commercializing sterile-injectable products in a portfolio of proprietary, value-added, prefilled delivery systems. The company’s team of 80 employees harmonize all aspects of combination product development and manufacturing with effectively synchronized operations, including chemistry, device development, manufacturing equipment development, material science, quality and regulatory, in-house cleanroom assembly operations, and in-house sterile fill-finish. Aktiv commercializes drug products independently as well as supporting other pharmaceutical companies address unmet needs and create competitive advantage in the market. Aktiv leading products are proprietary emergency medicine in autoinjectors. 

Aktiv’s mission is to deliver peace-of-mind to patients and their communities, and its values are truth, perseverance, caring, and goodness. The company’s culture emphasizes diversity, equity, and inclusivity and implementing leadership across the entire organization. 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 believe that our DEI initiatives are an opportunity to make a difference beyond our organization, in our community and society. Aktiv is grateful to be taking part in the individual journey of its employees and is striving to support a balanced life experience. We are striving to create a safe and inviting work place in which our team would be excited to come in the door at the beginning of the work day, and leave at the end of their day with a sense of accomplishment and value. 

We are currently hiring for a Process Engineer III

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

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

Employee Benefits Include:

• The compensation range for the Process Engineer III is $80,000 - $110,000 annually. 
• 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!
• This position will be on location, but flexible work arrangements can be discussed. 

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 and Experience:

• Bachelor’s degree in science or engineering field preferred 
• Minimum 4 years industry experience including related industries