Engineering Technician

BioSpace; Charlottesville (VA); On-site; USD 43,000 - 53,000; Full time

Job summary

Afton Scientific, a Virginia-based contract manufacturing organization, is seeking personnel to support engineering, validation, and sterile manufacturing activities. The role involves hands-on setup, equipment qualification, and cross-functional collaboration to ensure cGMP compliance.

Ideal candidates have a technical degree or associate degree, strong communication skills, and the ability to work on-site regularly.

Qualifications

• Technical degree or 2-year associate degree or equivalent industry-related experience.
• Basic computer proficiency including Word and Excel; ability to learn additional software.
• Professional communication and interpersonal skills.
• Ability to maintain positive working relationships with coworkers, supervisors, and vendors.
• Ability to work on-site on a regular basis.

Responsibilities

• Assist in the execution and reporting of engineering protocols and formal studies.
• Support the evaluation, installation, and qualification of new instrumentation and equipment.
• Evaluate, select, and order parts and components for engineering batches.
• Perform hands-on setup and preparation of sterile pharmaceutical products and components.
• Support validation activities, including equipment setup and execution of validation studies.
• Perform Pharmaceutical Operator II duties as needed to support operations.
• Participate in product and process development initiatives.
• Maintain validation activities in compliance with cGMP requirements.
• Review operational deviations, change controls, validation protocols, and formal studies, as applicable.
• Collaborate effectively with Engineering, Operations, Quality, and other departments to support manufacturing objectives.

Skills

Technical degree

MS Word / MS Excel

Professional communication

Interpersonal skills

On-site work

Education

Technical degree or 2-year associate degree

Job description

Afton Scientific is a contract manufacturing organization (CMO) 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

NOTE: Afton Scientific does not sponsor work visas. No recruiters please.

Compensation

$31.35 to $38.46 per hour, depending on experience and qualifications

Placement within the range will be based on qualifications, experience, internal equity, and demonstrated competencies.

Primary Responsibilities

• Assist in the execution and reporting of engineering protocols and formal studies.
• Support the evaluation, installation, and qualification of new instrumentation and equipment.
• Evaluate, select, and order parts and components for engineering batches.
• Perform hands-on setup and preparation of sterile pharmaceutical products and components.
• Support validation activities, including equipment setup and execution of validation studies.
• Perform Pharmaceutical Operator II duties as needed to support operations.
• Participate in product and process development initiatives.
• Maintain validation activities in compliance with cGMP requirements.
• Review operational deviations, change controls, validation protocols, and formal studies, as applicable.
• Collaborate effectively with Engineering, Operations, Quality, and other departments to support manufacturing objectives.

Minimum Qualifications

• Technical degree, two-year associate degree, or equivalent industry-related experience.
• Basic computer proficiency, including Microsoft Word and Excel, with the ability to learn additional software applications.
• Professional communication and interpersonal skills.
• Ability to maintain positive working relationships with coworkers, supervisors, and vendors.
• Ability to work on-site on a regular basis.

Preferred Knowledge And Experience

• Experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
• Working knowledge of cGMP requirements and validation principles.
• Experience supporting manufacturing equipment, engineering projects, or validation activities.
• Familiarity with aseptic processing and sterile manufacturing operations.
• Strong mechanical aptitude and troubleshooting skills.
• Ability to work independently while contributing effectively within a cross-functional team.