Report this job

---

What is the problem? *

Incorrect company
Incorrect location
Job is expired
Job may be a scam
Other

Description

Job Title: Sr. Manufacturing Equipment Maintenance Technician

Pay: BR

Shift: Swing shift M-F (3:00pm 11:30pm)

Laptop: No

How will you make an impact?

The Sr. Mfg Equipment Maintenance Technician position has the following responsibilities for the Manufacturing Engineering group. This group supports the Pleasanton manufacturing plant by maintaining, calibrating and repairing laboratory equipment. The candidate will also be responsible for participating in several other activities such as process improvements (8-step kaizen events, 5S and JDI), Technical writing, representing group in ongoing projects and researching and ordering parts/tools.

What will you do?

• Performs maintenance, testing, troubleshooting, calibration and repair on a variety of manufacturing and testing Instrumentation.
• Carries out routine repairs on a daily basis.
• Provides technical support to internal customers on operational or maintenance aspects of system equipment.
• Works independently and prioritizes work schedule of service calls, PM s and Projects majority of the time, may require direction from Lead or Supervisor sporadically.
• Maintains own tool inventory to ensure adequate supply to perform duties.
• Works with team and administrator to assure there is adequate supply of spare parts in stockroom (Specifies and requests purchase of components).
• Performs all administrative duties including documenting maintenance and repair calls in SAP as well as completing required documentation and reports.
• Proficient and compliant with ISO standards and practices.

How will you get here?

• Minimum AS in Electronics/mechanical/electro-mechanical, bachelor s in engineering preferred
• Must have minimum of 1-2 years of experience with Field Service or In-House Service
• Experience with DNA/RNA Synthesizers is highly desirable (Example models: ABI 3900, 394, BioAutomation Mermade, Dr Oligo)
• Robotic experience is required. Experience with any of the following platforms is highly desirable: Hamilton Star and Starlet, Agilent Bravo, Tecan Evo and Genesis and Biomek FX and NX.
• Must have experience with handling hazardous materials and hazardous waste
• Must have experience with Pneumatic instruments
• Must have experience with Vacuum systems.
• Must have experience with general handheld tools plus multi-meters and other electronic test equipment.
• Experience with manual pipetting is preferred
• Experience with FDA regulated system development/design control is a plus.

Knowledge, Skills, Abilities

• Broad knowledge of state-of-the-art optical imaging, precision motion control, microfluidics, automation systems, and signal processing technologies.
• Knowledge of GMP, ISO 9001 and or 13485 Standards
• Advanced technical writing and verbal skills to produce reports, documents, and communicate with customers.
• Must be able to work effectively alone under minimal supervision and complete assigned work targets in a timely manner.
• Excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple and changing work tasks and priorities.
• Excellent verbal and written communication skills and the ability to interpret and summarize scientific/technical results in a clear, concise, accurate manner.
• Demonstrated ability to formulate and solve problems.
• Proficiency with Solidworks is a plus.
• Must be flexible to work swing shift, weekends and overtime as needed.

Responsible for cGMP manufacturing operations at the Brammer Lexington site Downstream Operations.

Responsibilities include:

Executing aseptic operations within a Biosafety cabinet and cleanroom environment.
Preparation of buffers to support downstream purification activities.
Performing critical downstream activities through Chromatography, TFF, Viral Filtration, and Final Formulation.
Documentation of all activities in Batch Records, Logbooks, Forms, Etc.
Follows verbal and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation.
Identifies, escalates and documents events and subtle variances that deviate from normal operation; participate as needed in investigations.
Monitor processes using automated production systems and controls with limited supervision.
Equipment preparation, sanitation, and disinfection.
Demonstrates the ability to troubleshoot basic mechanical operations.
Conducts training for less experienced personnel.
Work in accordance with site and company EHS programs.
Work in accordance with regulations, detailed protocols, Batch Record s, SOP s and Work Instructions.
Fulfills the role of a lead trainer on numerous operations and is an area SME.
Fulfills the role of Team Lead in the absence of the team supervisor. Responsible for assignment of duties to all team members, ensuring execution of duties, communicating at daily scheduling meetings, and providing technical support as needed.
Work Hours:

The incumbent will onboard and support project activities Monday through Friday, 8:00 AM to 5:00 PM. The position may transition to a 12-hour day time rotation as the site becomes operational.
May require overtime to work evenings, weekends or holidays, as required to meet project timelines.
Experience and Skills
Expectations:

Effectively utilizes Microsoft office applications.
Must be able to work in a fast-paced environment.
Strong attention to detail through a 12-hour shift.
Solid understanding of aseptic principles.
Work towards solutions to given problems and operate under cGMP requirements.
Work cross-functionally with support groups such as Facilities, Engineering, Contamination Control, MST, Quality Control and Quality Assurance.
Qualify to work in aseptic environments to complete required production activities.
Maintain facility and room inspection readiness.
Ability to lift at least 50lbs.
Ability to aseptically gown and/or sterile gown as needed.
Minimum Qualifications:

Bachelor s degree with 4-6 years of industry related experience on=the-floor leadership or subject matter expertise in cGMP manufacturing.
High School diploma and 5-7 years industry related experience of on-the-floor leadership or subject matter expertise in assigned area s core operations.
Independently motivated and can work within a cross-functional team
Note: This job description is not all-inclusive. Additional duties may be performed, as assigned. It acts as a guideline and is subject to change over time.