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 Engineering Supervisor.
The Position: Leads development plan, development schedule and budget for Process Development Engineering. Technical SME and lead for drug, device, and combination product process development and characterization. Lead and manage Process Development team to meet company objectives.
Aktiv Pharma Group offers a wealth of benefits to our employees and their families.
Employee Benefits Include:
- The compensation range for the Process Engineering Supervisor is $100,000 - $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.
- Directs and performs project management and engineering functions, including (but not limited to): scope definition and management, process design, budgeting, project management/scheduling, purchasing, cost estimating, documentation, report writing, onboarding and training
- Monitors team progress and provides support to ensure engineering team is on track. Communicates team progress and delays to leadership
- Supports the career development of assigned staff
- Participates in the recruiting and interviewing of new Process Development employees
- Supports project on-site execution and makes decisions to support projects and act as technical consultant
- Facilitates the definition of a project scope with stakeholders. Converts goals to tasks and steps. Within structure, plans own work, manages several, often concurrent, tasks to accomplish assigned tasks to meet or exceed expectations (cost, quality, time).
- Builds relationships, initiates, and cultivates open, honest relationships with colleagues, customers, contractors, and vendors by establishing rapport, developing an understanding of others’ needs, promoting common goals, and following through on commitments.
- Conveys information effectively through verbal, written, and presentations to stakeholders and team members, both internal and external
- Effectively assess and priorities both short to long term objectives and tasks for their area of responsibility and translate them into actionable work streams for engineering staff.
- Responsible for compliance with company policies and procedures and applicable regulatory guidance.
- Technical SME for quality by design development strategies
- Stays current with regulatory requirements and industry best standards.
- Develop registration and commercial size drug manufacturing processes for identified lab scale processes
- Writes and reviews batch records, work instructions, and other supporting documentation for manufacturing processes
- Runs engineering batches, coordinates batch testing, and evaluates results to determine next steps
- Writes risk assessments and pFMEAs to support the developed process
- Completes product specific technical investigation to determine root cause and identify appropriate CAPAs
- Write/support process development sections of regulatory filings
- Ensures robust technology transfer process from early stage development teams to MS&T
- Applies technology in innovative ways.
- Works closely with EH&S to ensure equipment and processes are safe for operator use and oversees safety of planned engineering activities
Job Qualifications
Competencies, Knowledge, Skills, and Abilities:
- Pharmaceutical or device manufacturing experience and excellent knowledge of current Good Manufacturing Practices (cGMP) required
- Proven leadership or supervisory experience
- Proven ability to manage projects, create schedules, and adhere to timelines
- Excellent oral and written communication skills
- Skill in solving diverse and challenging problems
- Ability to manage multiple projects concurrently and under tight time constraints
Education and Experience:
- Bachelors degree in science or engineering field required
- Minimum 4 years industry experience
Additional Requirements/Licenses/Certifications:
- Must have reliable transportation.
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