Manufacturing Engineer I

Aktiv Pharma Group is a fast-growing company focused on addressing unmet medical needs through a proprietary drug delivery system. We are currently hiring for a Manufacturing Engineer I.

The Manufacturing Engineer I will support process validation and equipment qualification efforts of manufacturing and test equipment to help ensure safety, quality, and functional requirements are met. As needed, Manufacturing Engineer I will support manufacturing activities, including data collection and analysis to enable product development and quality engineers to make informed, data-driven decisions

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 Manufacturing Engineer I is $65,000 - $75,000 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.

• Creates manufacturing equipment specifications, including User Requirement Specifications, to detail the requirements that the off-the-shelf and custom manufacturing equipment needs to meet.
• Develops test procedures for the engineering characterization of components and assemblies following existing standard operating procedures (SOPs).
• Prepares protocols, including installation, operational, and performance qualifications, for validation or performance testing of new or modified manufacturing equipment, processes, or systems.
• Analyzes data from validation tests to determine whether systems and processes meet required criteria and specifications.
• Performs root-cause analysis of tested units to discover, characterize, and track failure modes.
• Introduces, assembles, and installs the fabricated manufacturing equipment and associated fixturing to the manufacturing floor and writes Manufacturing Process Instructions (MPI) to ensure reliability.
• Develops, evaluates, and improves manufacturing equipment design methodology including documenting specifications, standard work processes and tracking metrics.
• Works closely with product engineers to ensure product designs can be manufactured efficiently.
• Coordinates and effectively communicates with Aktiv Pharma Group staff such as Machine Shop staff, Lab staff, engineers, senior leaders, and the Contract Manufacturing Organization (CMO) and on occasion with outside machine shop contractors and parts suppliers.
• Trains Manufacturing Technicians, Lab Engineers and CMO personnel on how to use the developed equipment and ensures that the equipment is being operated according to safety and standard operating procedures; is proactive on safety concerns and takes action when appropriate.
• Works closely with Manufacturing Engineering Technicians to oversee process development and characterization on the manufacturing equipment to develop and challenge the process parameters and settings, as well as ensuring it meets all usability requirements.
• Documents engineering drawings and technical reports to ensure reliability and to meet regulatory standards.
• 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 Pharma Group's mission, vision, and values.
• Strong understanding of Engineering analysis and concepts, engineering drawings, technical documentation, and math calculations.
• Writing ability and analytical ability to develop processes and capture them to document manufacturing processes and standard operating procedures (SOPs).
• Oral communication to be able to communicate with other engineers to explain the process for making a product, choice, or decision and for collaboratively critiquing a design and resolving problems.
• Working knowledge of mechanical engineering, product design and plastic part design.
• Ability to recognize problems and take prompt action to resolve them.
• Ability to analyze and assess a process or situation with a view to improving it.
• Ability to handle different and specialized situations, ability to change direction quickly.
• Ability to originate and develop complex ideas in new and undefined areas.

Experience:

• A minimum of two (2) years of related experience preferred.
• An equivalent combination of education and experience may be substituted on a year-to-year basis.

Additional Requirements/Licenses/Certifications:

• Must have reliable transportation.
• Valid driver's license.