Job Description
This role requires advanced expertise in an Aseptic Clean room environment at a Process Development, Research and Development, or cGMP facility. The position entails inspecting, maintaining, and repairing laboratory and clean room equipment to ensure optimal operating results. The successful candidate will manage laboratory equipment assets while adhering to local, state, and federal regulations. Responsibilities include promoting preventive and predictive maintenance programs and scheduling corrective maintenance efficiently to minimize impact on production processes.
ResponsibilitiesCollaborate closely with corporate BioMedical Operations as a site point of contact.Monitor cleanroom environment for temperature, humidity, particles, and impurities.Utilize and track sensors and systems to oversee facility health.Perform detailed analysis of monitoring systems data.Log, track, and recommend actions to maintain cleanroom operations within controlled limits.Manage lab equipment in clean rooms, process development labs, and supporting spaces.Track preventative maintenance programs and documentation using CMMS.Maintain current facilities and lab equipment documents ready for audits.Onboard and manage GMP lab equipment in CMMS.Support site with IR, Event notifications, Deviations, Change Controls, and CAPA.Perform root cause analysis on cGMP findings.Manage equipment repair and documentation in a cGMP procedural format.Assist in site audits and planned/unplanned audits.Source and purchase new equipment.Perform validations, re-validations, verifications, certifications, and IQOQ on equipment.Develop SOPs, WIs, and Job Aides for lab equipment use.Support business objectives by maintaining a conducive space for cell culture and microbial fermentation.Establish lab equipment maintenance strategies and procedures.Recommend specifications for airflow dynamics and Cleanroom Airflow Optimization.Manage daily equipment operations and resolve escalated issues.Investigate clean room operational issues.Install, repair, and calibrate complex laboratory equipment.Manage and schedule lab equipment repairs and maintenance with vendors.Manage small to medium scale projects related to laboratory equipment or networked systems.Maintain DI, RO, and WFI water systems.Perform maintenance on Bottle washers, Bioreactors.Communicate status, timelines, and critical issues effectively within the organization.Adhere to established operating procedures and practices safely.Provide support for miscellaneous projects or issues across business units.Perform additional duties as assigned.Essential SkillsProficiency in biomedical, mechanical, calibration, and medical equipment troubleshooting.Bachelor’s Degree from an accredited institution.LEAN and/or Six Sigma Certification preferred.Certified Laboratory Equipment Specialist (CLES) or Certified Biomedical Engineering Technician (CBET).Eight or more years of BioMedical technician/Technical operations experience.One or more years of clean room work experience.Experience in lab maintenance management including PCA, Bioreactors, BSC, scales, lab pumps, incubators, lab refrigeration, lab grade gas, compressed air, WFI and DI water systems, sterilizers, and washers.Experience working collaboratively with QA and Operations.Knowledge of cGMP equipment start-up (IQ, PQ, OQ, FIT, SIT) validation.Familiarity with regulatory/quality compliance including FDA, EU, cGMP, and OSHA.Proficiency in Microsoft Office including Outlook, Word, Excel, Visio, and PowerPoint.Knowledge of computerized maintenance management systems.Additional Skills & QualificationsPrefer pharmaceutical industry experience.Preferred experience with CMMS and BMS.Experience with Master Control, Siemens Controls, Card Access, high pressure boilers, Clinical Grade Biologics, and waste streams.Knowledge of Material, Waste Personnel, process flow, and airflow standards.Knowledge of PPE usage in clean room environments.Understanding of lab equipment washing and sterilization.Work Environment
The laboratory is large, well-lit, clean, and provides a positive working environment. The site is expanding with a new Microbiology laboratory. Training will be Monday-Thursday from 7am-5:30pm for up to 3 weeks. The working shift will be Tuesday-Friday from 1pm-11:30pm. The role involves working in the lab with heavily automated testing systems.
Pay and BenefitsThe pay range for this position is $79040.00 - $90000.00/yr.
Benefits- medical, vision, dental 401k
Workplace Type
This is a fully onsite position in Norcross,GA.
Application Deadline
This position is anticipated to close on Jul 4, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.