PDS Tech Commercial Inc, is seeking qualified candidates for a Maintenance Technician position in Berkeley, CA.

　　POSITION SUMMARY: Responsible for overseeing the clinical manufacturing of monoclonal antibodies (mAB) Drug substance at the Cell Culture Technology Center (CCTC). Collaborates closely with Biological Development (BD) and Manufacturing Science and Technology (MSAT) to facilitate new product introductions and ensure platform alignment.

　　POSITION DUTIES & RESPONSIBILITIES:

　　Oversee all aspects of clinical manufacturing, including Cell Expansion, Cell Culture, Purification, Solution Preparation, Weigh/Dispense, freezing, and product storage.

　　Maintain seamless collaboration across different areas of the manufacturing process.

　　Ensure all activities adhere to the designated schedule.

　　Manage the manufacturing of products at various phases of the product life cycle, demonstrating a clear understanding and effective communication of differences in documentation, sample handling, automation, and cGMPs for each phase.

　　Provide feedback and troubleshoot single-use technology (SUT) throughout the manufacturing process.

　　Collaborate cross-functionally to ensure process control and escalate and investigate any issues.

　　Review and redline controlled documents for various equipment/processes.

　　Utilize effective communication methods (oral, written, presentation) to facilitate knowledge and information transfer across shifts, to management, and cross-functionally.

　　Raise and support investigations of deviations.

　　Participate in safety investigations for CCTC and promote safe behaviors at all times.

　　Demonstrate flexibility by adjusting shift schedules based on business and process needs.

　　Provide off-hour coverage, including nights, weekends, and holidays, as needed to meet business requirements.

　　Ability to lift 45 lbs.

　　REQUIREMENTS/PREFERENCES: Education Requirement(s):

　　Minimum of a BS in a science-related field is preferred.

　　Minimum of 2+ years of experience.

　　Transferable skills will be considered or an equivalent combination of education and experience.

　　Skill & Competency Requirements:

　　Demonstrates a strong tendency towards independent thinking and decision-making.

　　Capable of making logical decisions independently for multiple process workstreams with limited information or supervision.

　　Works with the highest level of flexibility.

　　Responds easily to last-minute changes in the production schedule.

　　Experienced in cGMP and GDP requirements for pharmaceutical manufacturing.

　　Preferences:

　　Experience with data integrity and regulatory requirements for pharmaceutical manufacturing.

　　Proficient in the operation of thermo SUM, 200L and 2000 bioreactors, Akta ready XL, Akta ready gradient, and Akta ready Flux XL.

　　Familiarity with business IT systems (Delta V, Team, Outlook, SAP, etc.).

　　Proficient in Microsoft Office with excellent computer skills.

　　Job Title: Maintenance Technician

　　Job Type: Full time; Consultant (7 months )

　　Pay Rate: $ 25.89

　　Pay Details: $25.89 per hour

　　Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

　　Equal Opportunity Employer/Veterans/Disabled

　　To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.pdstech.com/candidate-privacy

　　The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.