Project Engineer

2 weeks ago

Charlottesville, United States Afton Scientific Corporation Full time
About Afton Scientific. LLC

Mission: Providing reliable pharmaceutical services and lasting relationships within the industry for over 30 years.

Afton Scientific is a contract development and manufacturing organization (CDMO) in Virginia that specializes in small-batch filling of injectables from clinical trials to approved commercial drugs.

Utilizing 35,000 Sq. Ft of manufacturing, lab, warehouse, and administrative space, Afton provides custom, innovative solutions for clinical to commercial sterile manufacturing, packaging and labeling, analytical and micro lab services, and pharmaceutical support services.

Our Ready-To-Fill(r) line continues with our philosophy of guidance and support for our clients. It offers top-quality pre-sterilized components to those who can fill in-house.

Position Summary:

The Project Engineer at Afton Scientific will play a key role in the design, validation, commissioning, and execution of both new and ongoing capital building projects. This is a critical position aimed at supporting Afton's continued growth and expansion, where you will apply your expertise to implement innovative technologies and ensure the successful completion of facilities that meet strict regulatory standards.

Essential functions of the job include but are not limited to:

  • Develop and manage comprehensive project plans, including timelines, milestones, and resource allocation. Coordinate project schedules with internal teams and external stakeholders, ensuring that all deadlines are met.
  • Develop and maintain project budgets, tracking costs, and ensuring projects are completed within budget.
  • Identify, assess, and mitigate risks that could impact the project's timeline, quality, or cost.
  • Oversee the validation and commissioning of new systems or facilities to ensure they meet operational and safety standards.
  • Support execution of Commissioning, Qualification, and Validation (CQV) activities for syringe, cartridge and vial filling systems including Factory Acceptance Test (FAT), Site Acceptance Test (SAT), Installation Qualification (IQ)/Operational Qualification (OQ), Performance Qualification (PQ), and Aseptic Process Simulation.
  • Management of equipment vendors including project execution, on-site maintenance and calibration visits, vendor-supplied training of operation and maintenance staff, management of continuous improvement projects, and spare parts assessments.
  • Lead support of aseptic filling equipment and barrier systems, e.g. isolator.
  • Responsible for delivering cycle development including VHP cycles for Isolated filling equipment.
  • Manage change parts and validation associated with filler component format changes as per site change control procedures.
  • Participate in regulatory inspections (e.g. FDA or other) inspections as a Subject Matter Expert (SME).
  • Collaborate with various departments to ensure consistency in process development; process harmonization within site
  • Coordinate staff training and promote knowledge sharing within the organization
  • Identify and engage with subject matter experts, as needed
  • Work with quality leads to ensure proper quality and compliance controls across people, process and technology
Qualifications:

Minimum Requirements:
  • Bachelor's degree with at least 5 to 7 years of related or direct project management experience as it relates to cGMP/aseptic filling, facility design, process development and validation of pharmaceutical manufacturing equipment
  • Degree preferably in software or automation engineering, or related science or engineering field
  • Demonstrated ability to manage and deliver large capital projects ($5MM +).
  • Must be able to manage teams of varying education levels to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches.
  • Direct experience and exposure to sterile processing equipment and operations, including formulation and filling
  • Write, review, edit and approve master documents as applicable; SOPs, Batch Records, validation protocols and reports
  • Exceptional problem-solving ability to solve technical problems and implement projects on a schedule.
  • Strong mechanical aptitude required
  • Ability to explain complex technical issues to external customers / agencies.
  • Experience with greenfield facility CQV and production startup desired.
Other Required:
  • Exceptional organizational, customer service, interpersonal communication skills with the flexibility to thrive in a fast paced, changing environment and the ability to actively participate and sometimes lead cross functional teams
  • Ability to work independently with little to no instruction on routine work
  • Exercises judgment within generally defined practices selecting an approach for obtaining solutions
  • Excellent communication and interpersonal skills
  • Adaptable to changing priorities as project demands change.
  • Team player contributing to a positive, collaborative working environment
  • Extended work hours may be required to meet business demands
  • Must be able to read, write, speak fluently and comprehend the English language
Physical Demands:
  • Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects.
  • Repetitive motion. Substantial movements (motions) of the wrists, hands, and/or fingers.
  • Close visual acuity required to perform activities such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading.

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