Apex Systems is looking for a Manufacturing Bio process Technician with one of our biotech companies in SSF, CA.
If interested, please send Ethan Webb an email at Email blocked - click to apply
Duties: **Candidates must be able to work nights, days and weekends**
These positions are specific to night shifts
- Responsible for producing innovative bio therapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment, and maintain areas in high state of inspection preparedness.
- Operates production equipment for cell culture or purification that may include culture growth, process monitoring, sampling, harvesting, purification, formulation, freeze thaw and transfer. Performs media/buffer solution preparation operations. Maintains records and clean room environment to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP). Responsible for being proficient in one functional area. Understands and applies biological, chemical and mechanical principles and techniques
- Operate systems that clean and sterilize tanks and filtration systems.
- Prepare solutions for the production process.
- Review documentation and check all calculations (e.g. tickets, labels, equipment reading).
- Trouble shoot equipment and process problems.
- Comply with safety requirements, cGMP, SOP and manufacturing documentation.
- Use of automation to perform production operations.
- Provide support to Manufacturing to meet production demands.
- Operate automated systems for equipment operation.
- Assemble and prepare equipment for production.
- Exhibit detail oriented documentation skills
- Communicate effectively and ability to work in a team environment.
- Exhibit professional interpersonal skills.
- Work with coworkers and supervisor to effectively troubleshoot minor equipment and process issues.
- Follows established safety and environmental guidelines and procedures for all work performed. Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions. Fosters a positive safety culture in which no one gets hurt.
- Operate bioreactors, centrifuges, other harvest systems and protein purifications units.
- Operate and clean fixed tank and filtration systems
- Operate large scale column chromatography systems.
- Operate small-scale cell culture areas and systems by operating cleaning, set up, and maintaining 20L bioreactors; inoculating and maintaining spinner seed cultures using aseptic techniques, maintaining cell banks; and performing general seed lab operations.
- Perform Solution Preparation activities (media and buffer make-up)
- Clean, assemble, and sterilize equipment using glass washers and autoclaves.
- Perform automated CIP and SIP of fixed equipment.
- Work Environment/Physical Demands/Safety Considerations Schedule could include a non-rotating 4-day (10 hour shift), one weekend day, evening or night hours, or full off-shift hours. Expected to be on feet f 8 to 10 hours a day.
- Climb upwards of 6 flights of stairs a day to maneuver within the manufacturing facility. Lift up to 25lbs may be required. Environment requires approved gowning based on QS38 standards, gloves and steel toe boots to be worn.
- No makeup or jewelry can be worn when working in the clean room environment. Work in clean room environment with large mechanical equipment, piping, and pumps connecting to tanks serviced by high-pressure steam, water and air together this creates a loud environment. Work with hazardous materials and chemicals.
- Job Matrix a good working knowledge of biopharma technology and processes. Trained and skilled in all operational procedures of at least one manufacturing department. Demonstrated ability to independently document and record information related to the process. Occasionally makes routine decisions based on experience.
- Identifies and suggests solutions to common basic problems. Recognizes non-routine problems, investigates and suggests potential solutions. Judgment is required in resolving problems and making routine recommendations. Ability to recognize deviation from accepted practices is required. Job Requirements Knowledge, Skills, and Abilities Strong oral and written communication skills. Familiarity of computer-based systems Background in fermentation Ability to receive, interpret and provide basic information and materials involved with the day to day activities of performing the job.
Education: Degree in Life Sciences or engineering and 1 year related experience Or Associate Degree and 3 year experience Or High School and 5 years’ experience Biotech certificate from approved program.
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178