Manufacturing Quality Engineer

Full-Time

Petaluma, CA

DESCRIPTION

This position reports to the Director of Quality and supports the manufacturing quality activities by complying with GMP requirements. The incumbent is responsible for verification, validation, qualification, implementation of manufacturing process equipment, and the following duties:

• Provides leadership in developing processes, methods, and criteria for inspections (incoming, in- process, and final product).

• Reviews controlled documents including batch records, QC data, results, and master batch record for accuracy.

• Identifies and develops new quality metrics as needed

• Identifies and resolves production and manufacturing problems or issues using quality tools and techniques such as root cause analysis, statistical analysis, and CAPA.

• Installation and validation of rapid automation-based process equipment (robotic systems).

• Responsible for inspection, test and calibration operations

• Performs calibration (Gauges, Timers, Meters, Calipers) of tools and equipment; conducts tests on installed automation-based process equipment (robotic systems).

• Initiates, and reviews change orders, deviations, and manages control of non-conforming products.

• Develops engineering specifications, sampling plans, test protocols, manufacturing floor process flows, work instructions, test methods, master validation plans, and performs any other quality related activities as assigned.

• Determines conformance of products by following internal procedures and Quality System Regulation.

• Regularly monitors product quality by gathering and maintaining manufacturing quality metrics.

EDUCATION REQUIREMENTS

• Master’s degree in Mechanical Engineering with minimum of 3 years of experience in manufacturing environment or Bachelor’s degree in Mechanical Engineering with 5 years of experience in manufacturing environment.

ADDITIONAL EXPERIENCE REQUIREMENTS

• Experience in manufacturing/production and process control in a regulated industry (Pharmaceuticals, Medical Devices, Cosmetics or Dietary Supplements) highly preferred.

• Good understanding of 21CFR part 820, part 700, part 11, GAMP, ISO 9001, ISO 13485 and ISO 14971.

• Familiarity with automations systems, and PLC; Gage R&R, FMEA.

• Sound knowledge of Quality Control, Statistical Process Control, & Capability Analysis and tools.

• Proficiency in Minitab, Microsoft Office Suites and CAD Software/Solid Works.

• ASQ-CQE is desirable but not required.

• Knowledge of product inspection standards and sampling, advanced manufacturing, quality assurance, and pharmaceutical product development.

OTHER QUALIFICATIONS

• Detail oriented with well-developed organizational and analytical skills.

• Ability to work in a team environment and positive attitude is a plus.

• Experience working in a fast-paced, start-up environment is a plus.

Collidion is an equal opportunity employer.

Lab Intern

6-month Internship
Part-TIME
PETALUMA, CALIFORNIA

DESCRIPTION

Collidion, Inc. is seeking an intern to assist the Research & Development team. The Intern will work closely with the Director of Microbiology by assisting in antimicrobial research on various healthcare assets. We are looking for someone who is seeking to develop laboratory-based research experience in the areas of pharmaceutical and medical device.

Our regulatory, research & development, operations and creative teams work together to identify and build technologies that can improve the future of patients worldwide.

Under limited supervision and the guidance of the R&D team, the intern will be responsible for the following routine tasks:

• Maintains the microbiology laboratory

• Follows established procedures and best practices

• Prepares bacterial and spore suspensions

• Assists with bacterial and spore time-kill studies

• Assists with gram staining, filtering, aseptic techniques, evaluation of plates and test tubes for microbial growth

• Conducts Microbiological Analysis

• Prepares and maintaining culture media and solutions

• Performs growth promotion testing of microbiological media

• Ensures testing timelines are met

• Performs other miscellaneous lab maintenance activities

JOB REQUIREMENTS:

• Experience and sound knowledge of traditional microbiological methods.

• Must be proficient in aseptic technique, serial dilutions, quantitative enumeration of microorganisms, and Preparation of test media.

• Must be proficient in microorganism culturing techniques.

• Must have working knowledge and experience with standard laboratory practices, including microscopes, Autoclaves, sterilizing supplies, electronic balances, pipettes, and incubation.

• Critical thinking skills appropriate for advanced problem-solving activities.

• Maintains high standards of lab safety and health.

• GLP documentation experience strongly preferred.

• Records and maintains accurate test results and enters them into computer database.

• Must be capable of performing routine tasks in a self-directed manner.

• Desire to be part of a fast-paced dynamic research and development environment.

ADDITIONAL REQUIREMENTS:

• Minimum 2 years of microbiological testing experience.

• Demonstrated knowledge of a variety of microbiological concepts, practices, and procedures

• Demonstrated interpersonal communication skills.

• Must be results oriented, a quick learner, and able to respond to the urgent needs of the team ensuring all deadlines are met.

• Proficiency in Microsoft Suite.

• Ability to meet attendance standards.

• Must be detailed oriented, have a collaborative work attitude with strong interpersonal, organizational, and communication skills.

• Must meet all laboratory, production safety, and compliance training programs at Collidion Inc.

EDUCATION REQUIREMENTS:

• Currently a student in a Microbiology or a related major at a four-year college.

ADDITIONAL INFORMATION:

• Extension of the position will be considered on a case-by-case basis and at the sole discretion of the company.

• Collidion is an equal opportunity employer.