Description Summary The Mechanic I is primarily responsible for collecting, labeling and interfacing outside vendors to dispose of biological, chemical, hazardous and pharma waste from laboratory and manufacturing source…
Description Summary The Facilities Automation Engineer is responsible for overseeing the operation of the Building Management System (BMS), policies, and procedures for maintaining the system in a compliant GMP status. R…
Skills: Building Management System, GMP Compliance, Validation, Commissioning, HVAC
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Full-time
high school
Posted 33d ago
~40 hrs/week
Responsibilities
Responsible for the collection and disposal of hazardous waste and the general maintenance of facility utilities and safety equipment. Performs daily rounds to inspect and repair HVAC, plumbing, and electrical systems within a biotech environment.
Requirements
Requires a high school diploma and at least 3 years of experience in the biotech or pharmaceutical industry. Must possess knowledge of utility systems and the ability to read mechanical schematics and P&IDs.
Full job description
Description
Summary
The Mechanic I is primarily responsible for collecting, labeling and interfacing outside vendors to dispose of biological, chemical, hazardous and pharma waste from laboratory and manufacturing sources. Will support the Facility through inspection, repair and maintenance activities that may include testing safety equipment (e.g. Eyewashes, showers), inspecting fire extinguishers, spill kits, personnel protective gear, exit lighting, repairing HVAC equipment, plumbing, troubleshooting motors and electrical issues. Maintenance Mechanic I will conduct daily rounds of the Facility and Utility equipment.
Essential Job Responsibilities
Test Eyewashes and safety showers
Inspect fire extinguishers
Tests emergency lighting
Replace light bulbs
Replace ceiling tiles
Repair domestic plumbing issues i.e., clogged or overfilling toilets and urinals.
Drywall repair, Patch and paint
Fill liquid nitrogen dewars
Operate a forklift (Training and certification will be provided)
Operate equipment and supply transport vehicle to and from buildings (Valid DL required).
Oversee and escort vendors i.e., Pest control vendor
Routinely perform rounds and readings of utility equipment
Replace HVAC filters
Supplemental Job Responsibilities
Assist in performing maintenance on unitary equipment
Assist in replacing electrical ballasts
Assist in writing procedures for maintenance and calibration and assist with procurement of critical spare parts for all GMP systems.
Assist in spill prevention and spill cleanup as directed.
Perform hazard waste collection and disposal with outside vendors
Other duties may be assigned from time to time.
Requirements
Education and experience
Requires a minimum of a High School diploma and 3 years’ experience in the biotech/pharmaceutical industry or similar setting.
Knowledge, Skills, and Abilities
Good knowledge of utility and facility equipment such as HVAC, refrigeration, boiler, chiller, pumps & drives, RODI, WFI, and clean steam systems
Knowledge of mechanical maintenance required for utility systems.
Use of basic hand tools.
Able to read, write and utilize drawings, mathematics, and handbook formulas.
Read mechanical schematics and piping diagrams P&IDs.
Qualify to work in a clean room environment.
Possess basic computer skills.
Ability to communicate both orally and written in a clear manner.
Ability to perform work in the mechanical, pipefitting, or plumbing trades is preferred.
Proven biologics CDMO with U.S. FDA-registered facility. Early stage, late stage, & commercial manufacturing solutions.
Industry
Pharmaceutical Manufacturing
Company size
51-200 employees
Founded
2011
Headquarters
San Diego, California
LinkedIn followers
3,466
Bora Biologics: Accelerating Success in Biologics Development
With a proven track record of over 100 successful cGMP manufacturing batches and the development of more than 42 biologics and biosimilars, Bora Biologics exemplifies how experience drives success. We offer agile, comprehensive end-to-end CDMO solutions that optimize time and cost efficiencies for biopharma companies around the world.
Leveraging our global CDMO capabilities, our state-of-the-art, FDA-registered facility in the U.S., and our deep expertise in biologics development and manufacturing, we provide efficient and effective pathways to market for clients.
We specialize in a diverse range of biologics, including monoclonal antibodies (mAbs), bi-specifics, fusion proteins, recombinant proteins, and enzymes. From cell line development to commercial manufacturing, our team brings extensive global and regional regulatory affairs expertise to ensure compliance and success at every stage of the process.
+ Mammalian and Microbial GMP Manufacturing
+ Early, Late-Stage and Commercial Production
+ Integrated Process and Analytical Development
+ Formulation and Drug Product Development
+ Quality Control and Assurance
State-of-the-Art Facilities & Highlights
---------------
Bora Biologics | San Diego, California, USA
+FDA Registered
+130,000 sf GMP and R&D space
+14,000 sf temperature controlled GMP warehouse
+Single-Use Bioreactors (SUBs): 2 x 50L, 2 x 250L, 4 x 1000L , 2 x 2000L (in plan)
+Stainless Steel Fermentors: 1 x 150L, 1 x 300L (SUF)
+3 GMP suites
Bora Biologics | Zhubei City, Taiwan
+70+ cGMP batches with 100% success rate continuously since 2014
+48,000 sf of GMP and R&D space
+cGMP, ICH, FDA, EMA, TFDA, PIC/S
+Single-Use Bioreactors (SUBs): 2 x 50L, 4 x 500L (2 in plan)
Partner with us today to discover how our EXPERIENCE can accelerate your success.
Offices: 10394 Pacific Center Ct, San Diego, California 92121, US · 3F, No 22, Sec 2, Shengyi Rd, Zhubei City, Hsinchu County 302, TW
CDMOMammalian & Microbial GMP ManufacturingEarlyLate-Stage and Commercial ProductionIntegrated Process DevelopmentTechnical TransferCell Line DevelopmentMammalian Process DevelopmentAnalytical & Formulation DevelopmentDrug Product Development
Proven biologics CDMO with U.S. FDA-registered facility. Early stage, late stage, & commercial manufacturing solutions.
Industry
Pharmaceutical Manufacturing
Company size
51-200 employees
Founded
2011
Headquarters
San Diego, California
LinkedIn followers
3,466
Bora Biologics: Accelerating Success in Biologics Development
With a proven track record of over 100 successful cGMP manufacturing batches and the development of more than 42 biologics and biosimilars, Bora Biologics exemplifies how experience drives success. We offer agile, comprehensive end-to-end CDMO solutions that optimize time and cost efficiencies for biopharma companies around the world.
Leveraging our global CDMO capabilities, our state-of-the-art, FDA-registered facility in the U.S., and our deep expertise in biologics development and manufacturing, we provide efficient and effective pathways to market for clients.
We specialize in a diverse range of biologics, including monoclonal antibodies (mAbs), bi-specifics, fusion proteins, recombinant proteins, and enzymes. From cell line development to commercial manufacturing, our team brings extensive global and regional regulatory affairs expertise to ensure compliance and success at every stage of the process.
+ Mammalian and Microbial GMP Manufacturing
+ Early, Late-Stage and Commercial Production
+ Integrated Process and Analytical Development
+ Formulation and Drug Product Development
+ Quality Control and Assurance
State-of-the-Art Facilities & Highlights
---------------
Bora Biologics | San Diego, California, USA
+FDA Registered
+130,000 sf GMP and R&D space
+14,000 sf temperature controlled GMP warehouse
+Single-Use Bioreactors (SUBs): 2 x 50L, 2 x 250L, 4 x 1000L , 2 x 2000L (in plan)
+Stainless Steel Fermentors: 1 x 150L, 1 x 300L (SUF)
+3 GMP suites
Bora Biologics | Zhubei City, Taiwan
+70+ cGMP batches with 100% success rate continuously since 2014
+48,000 sf of GMP and R&D space
+cGMP, ICH, FDA, EMA, TFDA, PIC/S
+Single-Use Bioreactors (SUBs): 2 x 50L, 4 x 500L (2 in plan)
Partner with us today to discover how our EXPERIENCE can accelerate your success.
Offices: 10394 Pacific Center Ct, San Diego, California 92121, US · 3F, No 22, Sec 2, Shengyi Rd, Zhubei City, Hsinchu County 302, TW
CDMOMammalian & Microbial GMP ManufacturingEarlyLate-Stage and Commercial ProductionIntegrated Process DevelopmentTechnical TransferCell Line DevelopmentMammalian Process DevelopmentAnalytical & Formulation DevelopmentDrug Product Development