process engineer Broomfield, CO
Job description
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 Process Engineer II.
The Position: The Process Development Engineer II will develop manufacturing processes for new drug, device, and combination products and complete characterization studies to define CPPs and design space to ensure establishment of robust processes capable of producing quality products.
Aktiv Pharma Group offers a wealth of benefits to our employees and their families.
Employee Benefits Include:
- The compensation range for the Process Engineer II is $78,000 - $85,000 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, device and combination product manufacturing processes from identified lab scale processes
- Collaborate closely with device development, drug product development, equipment development, operations and MS&T SMEs to create robust manufacturing processes capable of producing high quality product
- Support drug product development, device development, and equipment development activities as process SME, where appropriate
- Define user requirements for new process related equipment
- Design, execute, and analyze DOE studies
- Write/review batch records, work instructions, and other supporting documentation for manufacturing processes
- Create incoming specifications for process aids
- Support creation of raw material incoming and product release specifications
- Maintain device engineering drawings from design freeze through transfer to MS&T
- Perform material compatibility studies for materials that contact product during manufacturing process
- Run engineering batches, coordinate batch testing, and evaluate results to determine next steps
- Summarize and present technical findings and development efforts to leadership
- Create and maintain action plans and timelines for completing assigned tasks
- Research new technologies and propose options for overcoming process challenges
- Write risk assessments and pFMEAs
- Write/support process development sections of regulatory fillings
- Support equipment and process qualification efforts
- Lead/support root cause investigations, 5-why’s, and CAPA generation where appropriate
- Other duties as assigned
Job Qualifications
Competencies, Knowledge, Skills, and Abilities:
- Pharmaceutical or device manufacturing experience and excellent knowledge of current Good Manufacturing Practices (cGMP) required
- Strong understanding of Engineering analysis and concepts, engineering drawings, technical documentation, and math calculations.
- Ability to handle different and specialized situations, ability to change direction quickly.
- 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
- Experience with good documentation practices required
- Competence owning and leading change control implementations
Education and Experience:
- Bachelor’s degree in science or engineering field preferred
- Minimum 2 years device or pharmaceutical industry experience
Additional Requirements/Licenses/Certifications:
- Must have reliable transportation.
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