Job Title: Manufacturing Technician
Location: Haverhill, MA
Responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment, and maintain areas in high state of inspection preparedness. Operate production equipment for cell culture or purification that may include culture growth, process monitoring, sampling, harvesting and purification. Perform media/buffer solution preparation operations. Maintain 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 or more functional areas. 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.
• Follow 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. Foster a positive safety culture in which no one gets hurt.
• A good working knowledge of biopharmaceutical 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.
• Operate fermenters, 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 batch feed fermenters; inoculating and maintaining spinner seed cultures using aseptic techniques, maintaining cell banks; and performing general seed lab operations, Column packing, chrome skid operations UFDF operation, bulk fill and purification.
• 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.
Education and Experience
• 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
Knowledge, Skills, and Abilities
• Strong oral and written communication skills.
• Familiarity of computer-based systems
• Background in fermentation and purification
• SAP a plus
• Ability to receive, interpret and provide basic information and materials involved with the day to day activities of performing the job.
To apply, please send your MS Word resume along with salary requirements to:
An equal opportunity employer, m/f/d/v.
Please reference BioTechPharmJobs.com when responding.