Biomedical Equipment Technician IV (GA) (28522)

BioBridge Global; Norcross (GA); On-site; USD 60,000 - 80,000; Full time

Job summary

BioBridge Global is seeking a Biomedical Equipment Technician IV to oversee laboratory and clean room equipment maintenance. The role requires substantial experience in biomedical operations, emphasizing compliance with cGMP standards and providing exceptional service. Join a leading organization committed to quality and customer satisfaction.

Benefits

Competitive salary

100% Employer Paid Life Insurance

401(k) with Employer Contribution

Paid Time Off (PTO)

Group Health Medical Plan with prescription coverage

Qualifications

• Requires 8+ years of biomedical technician experience.
• Clean room work experience required.
• LEAN and/or Six Sigma Certification preferred.

Responsibilities

• Inspect, maintain, repair lab and clean room equipment.
• Monitor cleanroom environment and equipment performance.
• Develop preventive maintenance programs.

Skills

Analytical skills

Communication skills

Problem-solving

Attention to detail

Teamwork

Education

Bachelor’s Degree

Tools

CMMS

Microsoft Office

Job description

QualTex Laboratories is an FDA-registered and CLIA-certified organization that provides state-of-the-art, high volume capacity donor screening and biological testing services. It is one of the largest independent, nonprofit testing laboratories in the United States and has locations in San Antonio and Atlanta

Job Title: Biomedical Equipment Technician IV

Revision: 0002

Job Code: 703719

Shift: Tues-Fri 1:00 p.m. – 11:30 p.m. with occasional on-call events

FLSA: Exempt

Hybrid? N

Dept.: Biomedical Operations

Business Unit: BioBridge Global

CPF Level: P4

General Summary

The incumbent will have advanced knowledge working in an Aseptic Clean room environment at a Process Development, Research and Development, and or cGMP facility.

This position will be responsible for inspecting, maintaining, and repairing the laboratory and clean room equipment to ensure optimal operating results.

The successful candidate will oversee the company’s laboratory equipment assets all while remaining in compliance with local, state and federal regulations.

This position will promote the implementation of preventive and predictive maintenance programs, and schedule corrective maintenance operations to be carried out quickly and efficiently with the least possible impact on the production process in a cGMP compliance manner.

This position will assist with the creation and implementation of Validations, Certifications, Verifications of equipment at a cGMP standard.

The incumbent will participate in creation and editing of SOP, WI, and Job Aides for equipment.

The incumbent will be an extension of the corporate BioMedical operations with primary responsibilities for a subsidiary business.

Commit to and abide by the character of BioBridge Global’s Core Values of Accountability, Stewardship, Pioneer, Integrity, Respect and Excellence (ASPIRE). Support, communicate and reinforce the mission and vision of the enterprise.

Provide world class customer service by capturing and being responsive to the voice of the customer (internal or external, including donors for select positions) through multiple feedback channels in order to resolve issues and drive satisfaction in accordance with the BBG customer engagement, feedback, and complaint processes.

It is essential that the incumbent have a valid driver's license and be at least 18 years old with a good driving record to meet organization driving standards.

Major Duties and Responsibilities

Essential Tasks

Works closely with corporate BioMedical Operations as a site point of contact.

Monitors or supports the monitoring of the cleanroom environment for temperature, humidity, particles, and impurities.

Utilizes and tracks several sensors and systems to monitor the health of the facilities.

Performs detailed analysis of monitoring systems data to include environmental monitoring system.

Logs, tracks and recommends actions to keep cleanroom operations within controlled limits.

Develops, manages, and maintains the lab equipment in the clean rooms, process development lab and supporting spaces.

Tracks preventative maintenance program and documentation on Master Control or a similar CMMS.

Keeps up to date current facilities and lab equipment documents in a cGMP format, ready for audits at any time.

Onboards new and manages GMP lab critical and non ‐ critical equipment in Master Control or a similar CMMS.

Supports the site with IR, Event notifications, Deviations, Change Controls, CAPA, to support cGMP compliance.

Performs root cause analysis on cGMP findings.

Manages equipment repair and documentation in a cGMP procedural format with vendors and internal stakeholders.

Supports in site audits and planned and unplanned audits.

Supports in sourcing and purchasing new equipment.

Performs Validations, re ‐ validations, verifications, certifications, IQOQ on equipment per manufacture specifications.

Develops SOP, WI, Job Aides for lab equipment use.

Supports the key stake holders business objective by maintaining a space conducive to performing Cell culture, Microbial fermentation, Product recovery, and downstream filtration and purification.

Establishes lab equipment maintenance strategies and procedures to improve operating efficiencies.

Recommends and establishes specifications for appropriate airflow dynamics (velocity, direction, pressure) and Cleanroom Airflow Optimization.

Manages daily equipment operations and resolves any escalated issues.

Investigates clean room operational issues.

Install, repair, and calibrate a wide variety of complex laboratory equipment.

Manages, and schedules lab equipment; repairs, pm, rm with approved vendors.

Manage small to medium scale projects in regards to laboratory equipment or networked systems. Knowledge in maintaining the DI, RO, and WFI water system.

Knowledge in performing maintenance on Bottle washers, Sterilizers, Bioreactors.

Effectively communicates status, timelines and critical issues to all levels of the organization as needed. Works in a safe manner in accordance with established operating procedures and practices.

Provide support among all business units for miscellaneous projects or issues as they arise.

Performs other duties as assigned.

Non ‐ Essential Tasks

Performs cost/benefit analysis and provides recommendations as needed for new systems or modernization of existing systems, computers, network configurations, etc.

Education

Requires a Bachelor’s Degree from an accredited four ‐ year college or university.

Licenses and/or Certifications

Valid United States Driver’s License

LEAN and/or Six Sigma Certification preferred

Lab Equipment, Certified Laboratory Equipment Specialist (CLES), Certified Biomedical Engineering Technician (CBET) recommended

Experience

Requires eight or more years of BioMedical technician / Technical operations experience.

Requires one or more years of clean room work experience.

Requires lab maintenance management experience: PCA, Bioreactors, BSC, scales, lab pumps, Incubators, lab grade refrigeration, lab grade gas, compressed air, WFI and DI water systems, Sterilizer, Washers.

Requires experience working with QA and Operations collaboratively.

Prefer pharmaceutical industry experience.

Preferred to have CMMS, BAS, BMS experience and background.

Prefer experience in the following areas: Master Control, Siemens Controls, Card Access, High pressure boiler, Clinical Grade Biologics, and Waist stream.

Knowledge

Must have knowledge on Material, Waist Personnel, process flow and air flow to meet ISO standards.

Must have knowledge on PPE usage in a clean room environment.

Prefer to have knowledge in lab equipment washing and sterilization.

Must have knowledge with cGMP equipment start up (IQ, PQ, OQ, FIT, SIT) validation.

Must have previous work experience with Microsoft Office, to include Outlook, Word, Excel, Visio and PowerPoint.

Must maintain knowledge of and perform according to Standard Operating Procedures (SOPs) and policies.

Must maintain familiarity of regulatory/quality compliance, to include FDA, EU, ISO, GHM, cGMP, OSHA, etc.

Must acquire a working knowledge of quality and laboratory systems.

Must have a working knowledge of computerized maintenance management systems.

Skills

Must be able to use and operate diagnostic tools and equipment.

Must be able to use computer software to support lab operations in a cGMP environment.

Must be capable of performing, evaluating, and reporting on laboratory systems.

Must be capable of operating motor vehicles in all types of weather conditions.

Must have excellent written and oral communication skills.

Must have excellent analytical/critical thinking skills.

Must be able to use basic hand tools.

Abilities

Must be able to document work following best practices.

Must be able to keep information confidential.

Must be able to make good sound judgment decisions.

Must be able to pass the PPE gown qualification for CR entry.

Must be able to respond to stat orders without delay and work calmly in emergency situations.

Must be neat in appearance and well groomed.

Must be professional, detail oriented, self ‐ motivated, innovative, creative, assertive, organized, communicative, and have the ability to work independently.

Must have strong analytical, numerical, and reasoning abilities in addition to the ability to exercise good judgment.

Must have the ability to think creatively and strategically while handling difficult and complex issues.

Must maintain good working rapport with all departments.

Working Environment

Works in a well ‐ lighted air conditioned and heated laboratory/department.

May be exposed to outdoor conditions.

May be exposed to electrical, mechanical and chemical hazards and other conditions common to a laboratory environment.

May be exposed to blood borne pathogens and other conditions common to a clinical laboratory environment.

May have bodily exposure to refrigerator/freezer temperature, especially hands and face.

Will work extended hours during peak periods.

May be required to work any time of the day, evening or night during the week or weekend, to include being on ‐ call.

Occupational Exposure Assignment ‐ Category I

Physical Requirements

Must be able to drive on behalf of the organization.

Will sit, stand, walk, and bend during working hours.

Requires ability to reach, lift and carry up to 20 lbs.

Requires manual and finger dexterity and eye ‐ hand coordination.

Requires normal or corrected vision and hearing corrected to a normal range.

Requires ability to work at heights from ladders, scaffolds and lifts.

Requires ability to work in confined or tight spaces.

We invest in our people by offering competitive compensation, excellent benefits, and the opportunity to work with the first blood center in America to receive the ISO 9002 accreditation!

All Full Time Positions Qualify for an Affordable and Competitive Benefits Package to include:

• Competitive salary

• 100% Employer Paid Life Insurance

• 401(k) with Employer Contribution

• 100% Employer Paid Long-term Disability Plan

• Paid Time Off (PTO)

• 100% Employer Paid AD&D

• Extended Illness Benefits (EIB)

• 100% Employer Paid Employee Assistance Program

• Shift Differentials

• Group Health Medical Plan with prescription coverage

• Paid Holidays

• Variety of Voluntary Supplemental Insurances

• Incentive Compensation Plan

• Voluntary Dental Coverage

• Educational Assistance Program

• Voluntary Vision

QualTex Laboratories, a subsidiary of BioBridge Global, is proud to be an Equal Opportunity Employer committed to providing employment opportunities to minorities, females, veterans, and disabled individuals. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, genetic data, sexual orientation, gender identity, or any other legally protected characteristics. For more information about your EEO rights as an applicant under the law, please click here. QualTex Laboratories maintains a Tobacco & Drug-Free Workplace.