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® 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.

Serving clients in 18 Countries
Successful NDA and ANDA drug registrations
In good standing with the FDA, PMDA, and MHRA

The Pharmaceutical Engineer at Afton Scientific will play a key role in validation, collaboration and execution of both new and ongoing projects and processes. This position will play a part in supporting Afton's continued growth and expansion. This role involves collaboration with leadership and various departments to ensure our success in meeting and exceeding our goals.

Essential Functions:

Designing, executing and reporting of engineering protocols; developing process changes; and evaluating and installing new instrumentation and equipment
Evaluating, selecting, and ordering parts and components required for engineering batches
Reviewing and modifying production instructions and operating procedures as they relate to process validation
At times, the direct supervising of production operations and occasionally, hands on work in the setup and preparation of sterile pharmaceuticals and components
Developing and improving product and processes
Maintaining validation operations in compliance with cGMPs
Interacting with clients, suppliers, and consultants as it relates to the engineering function
Write, review and edit master documents as applicable: SOPs, batch records, validation protocols and reports

Marginal Functions:

In-depth knowledge of HMI, PLC, motion controls, materials, and manufacturing processes is a plus.
Work experience in FDA regulated industry is a plus.

Requirements for Education and Work Experience:

· Bachelor's degree in Engineering (Chemical or Mechanical preferred).

· One year of manufacturing experience required. Pharmaceutical experience preferred.

· Working knowledge of software tools (MS Office Suite and other software)

Other Requirements:

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.

PI272330039

Afton Scientific. LLC

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Pharmaceutical Engineer