Quality Engineer I

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 a Quality Engineer I. 

The Position: The Quality Engineer (QE) is involved in the support of FDA Medical Device/Combination Product quality engineering methodologies, systems, and practices with focus on the application of quality in the manufacturing of pre-commercial devices.

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.

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

Employee Benefits Include:

• The compensation range for the Quality Engineer I is $65,000 - $75,000 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.

• Supports the Quality Engineering function by providing intelligence, discipline, problem solving and collaborative skills that can improve designs and processes. Provides technical approach to quality to support cross functional team members in development of new combination medical products.
• Supports manufacturing portion of the Quality Management System (QMS) that can encompass Standard Operating Procedures (SOPs) that are required by the Federal Drug Administration (FDA) for medical device/combination products.
• Investigates non-conforming events and product failures as they relate to design, manufacturing, and suppliers including root cause analysis and control implementation.
• Applies statistical analysis and controls throughout manufacturing processes.
• Perform risk assessment including feedback from validation, field service, post market surveillance, manufacturing indicators, corrective and preventative actions (CAPAs), etc.
• Supports Equipment and Process Qualification activities including active involvement in test establishment, validation, and execution as well as documentation (plan, protocol, report) generation, review, and approval.
• Supports Reliability Engineering including the FDA's reliability of 99.999% (“5-9s”) for emergency use autoinjectors and integration into sustainable manufacturing controls.
• Supports component incoming inspection supplier non-conformances and continuous improvements.
• Supports the implementation of continuous improvement activities to improve Aktiv’s QMS including device and drug development and manufacturing activities.
• Other duties as required and necessary to ensure the success of the organization.
  

Job Qualifications

Competencies, Knowledge, Skills, and Abilities:

• Ability to consistently promote, support, work, and act in a manner in support of Aktiv's mission, vision and values.
• Ability for problem-solving and root cause analysis.
• Must be able to interface well with others, especially Manufacturing Engineering and Product Development.
• Some familiarity with statistical techniques and ability to analyze results.
• Well-versed in communicating effectively with knowledge of basic computer applications.
• Preferred: Experience with new pharmaceutical and/or medical device product development (combination product preferred but not required)
• Preferred: Experience with manufacturing equipment, technical drawings, Gage R&R, and engineering concepts.
  

Experience and Education:

• A bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Process Engineering, Analytical Chemistry, or related technical discipline is required.

• Preferred: experience in a pharmaceutical or medical device environment.

Additional Requirements/Licenses/Certifications:

• Must have reliable transportation