Engineering Technician

PURPOSE: The purpose of this position is to perform routine inspection and calibration of ACC’s and customer instruments using standard operating procedures, perform re-qualifications of critical Production equipment, and provide assistance to the Engineering team with entry of Change Controls, Document Revisions, Complaints, Quality Events, and Deviations into the Electronic Document Management System as required.

GENERAL RESPONSIBILITIES:

• Perform routine incoming inspection, calibration, and troubleshooting of instrumentation with various software applications used for endotoxin and glucan testing.
• Draft validation protocols, execute re-qualifications for Production equipment, and create reports for Engineering and other ACC staff review and use.
• Enter relevant information into the Electronic Document Management System in support of Change Control, Complaints, Deviations, Quality Events, and Document Revisions.
• Participate in product development and process improvement team activities as required with the application of Design Control requirements if needed.
• Accurately complete all documentation relating to SOPs, Engineering Studies, and Validations.
• Support Engineering Department with validation and investigation activities.

KNOWLEDGE AND SKILL REQUIREMENTS:

• Detail oriented and excellent organizational skills.
• Excellent oral and written communication skills.
• Familiarity with calibration and validation terminology and practices.
• Hands-on ability to perform incoming inspections and calibrations of ACC instruments for internal/ external customers.
• Ability to work both independently and in a team environment.
• Excellent problem-solving skills.
• General knowledge of FDA cGMP and ISO 13485 requirements as related to manufacturing.
• Strong computer skills using Microsoft Office Word, Excel, and Outlook programs.

EDUCATION AND EXPERIENCE:

Ideal candidate will have a minimum of an Associate’s Degree in an Engineering, Life Sciences, or Biomedical discipline with at least 2 years of experience in the medical device, pharmaceutical, or biotech manufacturing industry or equivalent and familiarity with general requirements of operating in a FDA cGMP & ISO13485 environment.

GENERAL COMPETENCIES:

• Adapts to change, open to new ideas and responsibilities.
• Communicates well (written and verbal), delivers presentations, has good listening skills.
• Committed to finding solutions to problems, works well in a team environment
• Works well with internal and external customer, promotes a positive image of the company, and strives to solve issues raised by customers.
• Able to reach fact-based decisions, takes thoughtful approach when considering options, seeks input from others.
• Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record.
• Honest, accountable, maintains confidentiality.
• Takes action, seeks new opportunities, and strives to see projects to completion within the job description boundaries. Manages workload, works efficiently, and meets goals and objectives.
• Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback.
• Strives to understand contributing factors, works to resolve complex situations
• Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient work flow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can’t; can simplify complex processes; gets more out of fewer choices.
• Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services; complaint with quality system requirements.
• Looks for opportunities to increase knowledge, works to increase responsibility, and strives to achieve personal goals.
• Maintains current understanding of technical processes/equipment, uses technology to increase performance/productivity.

PHYSICAL REQUIREMENTS:

Occasionally reach with hands or arms, climb or balance, stoop, kneel, crouch, or crawl. Lift 26 to 50 lbs. 1-33% of the time, Carry 26 to 50 lbs. 1-33% of the time. Quiet noise is typical for the work environment of this job.

BENEFITS:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible schedule
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Tuition reimbursement
• Vision insurance