US- Technician (Entry)

Job Title: Technician (Entry)
Location: Berkeley, CA
Zip Code: 94710
Keyword's: #Berkeleyjobs; #Technicianjobs.
Start Date: Immediate

we put down Local candidates only

Job Description:
The primary responsibilities of this role are to:
Focus on preparing and sterilizing assemblies, tanks and other various type of equipment, and supporting buffer formulation and the sterile bulking process

Required Qualifications:
Requires two years of college in physical and/or biological science coursework, i.e. chemistry, biochemistry, microbiology, physics, and physiology. Relevant equivalent experience may be considered in lieu of some or all of the educational requirements.
Must have proven written and verbal communication skills. Demonstrate critical decision-making skills.
Must be able to read, write, speak and comprehend English.
Must have experience in aseptic A/B gowning and processing techniques, comfortable working without makeup and jewelry, and have good hygiene practices.
Experience working in a cGMP environment. Strict adherence to cGMPs is required.
Knowledge and experience with software typically used with Windows operating system and be able to navigate HMIs (human machine interfaces).

Intake Questions:
* Give me an overview of the role: What is a day like in this role? From a candidate"s perspective, what"s exciting about this role and team? What does this role accomplish for the business.
1. The detailed description in the posting tells the day"s activities
Prepares process equipment (including but not limited to Filler, Lyophilizer, Water bath & ancillary equipment, Stainless Steel tanks, Scales, Transfer lines, Hoses and small parts.
* Cleans and Sterilizes equipment using appropriate CIP (Clean-In-Place), SIP (Steam-In-Place) procedures.
* Performs daily or routine process operations in the Sterile Fill and Finish of biotech
and biological products (Kovaltry, Kogenate, and Jivi). Operates equipment for these
processes including:
o Dispenses chemicals and formulate solutions.
o Prepares acids and bases as necessary.
* Performs aseptic operations.
* Takes, analyzes and submits samples as required throughout the process.
* Monitors and controls operation with computer control systems.
* Completes all routine check sheets.
* Cleans equipment and maintains clean and orderly production facilities.
* Performs in-depth troubleshooting and root cause analysis of Kovaltry, Kogenate, and Jivi
equipment and process failures.
* Contributes to continuous improvement opportunities.
* Performs all operations in compliance with cGMP.
* Performs other related duties as assigned.

2. Assist with the manufacturing of licensed, commercial sterile product in an aseptic environment utilizing computer operated equipment. Manufacturing includes facility and equipment cleaning, aseptic filling, lyophilizing, capping, preparing and sterilizing assemblies, tanks, and other various types of equipment, and supporting buffer formulation and the sterile bulking process.
a. The primary responsibilities of this role are to:
b. Focus on preparing and sterilizing assemblies, tanks and other various type of equipment, and supporting buffer formulation and the sterile bulking process
Weigh out chemical kits for solutions.
EMO sampling
g. Monitor and control operation with computer control systems.
h. Perform aseptic operations.
i. Perform in-depth analysis of problems and contributes to continuous improvement opportunities.
j. Perform other related duties as assigned.

* Who will this person work with on a daily basis? Different qualified operators in each area, on average 8 FTEs a day
* Why is this role open? Is this more maintenance or new development work? Increased workload for production
* Location of this role (Onsite, Hybrid, Remote)? All onsite
* Tell me about the team dynamic/culture - long standing team that has worked together for years or fairly new team? How does the team work together? All teams have ops who have been here 15+ years with a great working culture
* What is the long term plan for the role? Conversion potential? Potential extension or conversion depending upon the business need post 6 months
* What does the ideal candidate background look like (ex: pharmaceutical specific background specific industry experience etc.)? Someone who worked in the field before and understands cGMP rules. It can be taught but ideally we want someone who has an idea with great work ethic and team work.
* What are you not interested in seeing and why? Someone who has bounced around from job to job, it shows they are not stable
* What kind of soft skills are you looking for? Communication, MS programs, computer skills, and written skills
* Are you open to candidates relocating (on their own) or do you prefer local candidates? Prefer local candidates
* What is the highest level of education is needed for this position? High school diploma
* Any certifications required for this role? no
* Hours per week? Any chance of OT? Shift start time? 40 hours per week. Potential for OT. Shift start times are as follows : 6am - 2:30pm, 6pm-2:30 am, 6:30am-3pm, 2:30pm-11pm, 10:30pm-7am,
* Any driving required? If so, what are they driving? How often? none
* Any travel required? If so, where? How often? none
* What is the typical work environment? Will they be required any PPE? If so, is it provided ? Scrubs, safety shoes, and safety glasses all to be provided
* Standard Dress Code? Standard street clothing, will be in scrubs primarily
* How have you filled these Requisitions in the past? yes - through Fieldglass
* Will you plan on interviewing these candidates? Interview process? Who from the team will be involved? Phone screen or face-to-face? Stress the importance of moving quickly - if we can avoid more than 1 interview per candidate, that will get someone in the door quicker. Yes interview will be done on teams (video chat lasting roughly 45 min)
* Will there be training for these roles? If so, when will the training be completed and how long will it be? Paid Training? Yes training is ongoing will focus 2 weeks on basics
* Timing for making an offer? Use this question as a discussion point about how quickly good candidates are off the market. ASAP

Belcan is an equal opportunity employer. Your application and candidacy will not be considered based on race, colour, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.