The Manufacturing Engineer is primarily responsible for providing technical assistance and engineering support to the manufacturing group. Additionally, improve existing processes, develop new and cost-effective manufacturing concepts as well as train production operators, mentor process technicians and engage maintenance personnel in resolving process, material, mold, tooling and equipment problems using systematic methods of troubleshooting, root cause analysis, and irreversible corrective action implementation.
Duties & Responsibilities:
Skills & Abilities:
Excellent written and verbal communication and effective human interaction skills.Flexible to change and possess a high degree level of integrity and can do attitude.
Education & Experience:
Physical Requirements:
The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The Manufacturing Engineer is primarily responsible for providing technical assistance and engineering support to the manufacturing group. Additionally, improve existing processes, develop new and cost-effective manufacturing concepts as well as train production operators, mentor process technicians and engage maintenance personnel in resolving process, material, mold, tooling and equipment problems using systematic methods of troubleshooting, root cause analysis, and irreversible corrective action implementation.
Duties & Responsibilities:
Skills & Abilities:
Excellent written and verbal communication and effective human interaction skills.Flexible to change and possess a high degree level of integrity and “can do attitude”.
Education & Experience:
Physical Requirements:
The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Reporting to the Facilities Manager, the Facilities Technician plays a critical role in supporting the operation, maintenance, calibration, troubleshooting, and repair of equipment, utilities, and building systems at Tiger San Diegos cGMP manufacturing facility and corporate offices. This position helps ensure facility reliability, regulatory compliance, and a safe, efficient working environment.
Key Responsibilities
Perform routine maintenance, calibration, and repair of manufacturing equipment, building systems, and facility utilities.Maintain facility and production areas in a state of inspection readiness and compliance with FDA and cGMP requirements.Complete preventive maintenance and calibration activities according to established schedules (daily, weekly, monthly, and annual).Execute equipment and facility maintenance activities in accordance with approved procedures and work instructions.Assist with equipment installations, upgrades, and modifications.Troubleshoot mechanical, electrical, and pneumatic systems and support timely resolution of equipment and quality-related issues.Coordinate and assist with external contractors, vendors, and site service providers.Support change management activities for validated equipment, utilities, and facility systems.Maintain accurate and complete maintenance documentation and records.Follow all applicable safety policies, procedures, and regulatory requirements.Perform additional duties and special projects as assigned.Required Education & Experience
High school diploma, GED, or completion of a technical/trade school program required.Minimum of 2 years of facilities, maintenance, or engineering support experience in a cGMP-regulated manufacturing environment.Hands-on experience diagnosing, troubleshooting, and repairing mechanical, electrical, and pneumatic systems.Experience supporting manufacturing equipment, utilities, and facility infrastructure preferred.Communication Skills
Ability to read, interpret, and follow safety procedures, technical manuals, maintenance instructions, and SOPs.Strong written communication skills with the ability to complete maintenance records, reports, and documentation accurately.Ability to communicate effectively with employees, contractors, vendors, and cross-functional teams.Technical & Computer Skills
Proficiency with Microsoft Office applications and general computer systems.Ability to learn and utilize maintenance management software and electronic documentation systems.Basic mathematical skills, including the ability to perform calculations involving measurements, weights, volumes, and distances.Certifications & Licenses
Valid drivers license required.Preferred Knowledge, Skills & Abilities
Understanding of facility systems, utilities, and building infrastructure.Knowledge of Building Management Systems (BMS), such as Siemens, Johnson Controls, or similar platforms.Strong understanding of cGMP, GMP, and FDA-regulated manufacturing environments.Experience using Computerized Maintenance Management Systems (CMMS), such as Maximo, BMRAM, or similar software.Ability to work independently with minimal supervision and manage multiple priorities effectively.Knowledge of applicable mechanical, electrical, biological, and workplace safety standards and practices.Demonstrated troubleshooting and repair skills for mechanical, electrical, and pneumatic equipment.Strong organizational and documentation skills with attention to detail.Effective verbal and written communication skills.Ability to collaborate with employees across multiple departments and organizational levels.Ability to function successfully in a highly regulated FDA-controlled environment.Professional discretion and ability to handle confidential information appropriately.Physical Demands and Work Environment
The physical demands and work environment characteristics described below are representative of those that an employee may encounter while performing the essential functions of this position. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of the job.
While performing the duties of this position, the employee is regularly required to use hands and fingers to operate tools, equipment, and computer systems; communicate verbally and in writing; and observe and assess equipment and facility conditions. The employee frequently stands, walks, sits, reaches, bends, stoops, kneels, crouches, climbs ladders, and works in manufacturing and facility environments.
The position may require the ability to move, transport, or position materials, tools, and equipment weighing up to 50 pounds, with or without reasonable accommodation.
Specific vision abilities required for this role include the ability to read documents, technical diagrams, equipment displays, and computer screens, with corrective lenses if needed.
Work is performed in both office and manufacturing environments. The employee may be exposed to moving mechanical parts, chemicals, cleaning agents, equipment noise, varying temperatures, and other conditions typical of a cGMP-regulated manufacturing facility.
The noise level in the work environment is generally moderate but may vary depending on operational activities and equipment in use.
Read LessReporting to the Facilities Manager, the Facilities Technician plays a critical role in supporting the operation, maintenance, calibration, troubleshooting, and repair of equipment, utilities, and building systems at Tiger San Diego’s cGMP manufacturing facility and corporate offices. This position helps ensure facility reliability, regulatory compliance, and a safe, efficient working environment.
Key Responsibilities
Perform routine maintenance, calibration, and repair of manufacturing equipment, building systems, and facility utilities.Maintain facility and production areas in a state of inspection readiness and compliance with FDA and cGMP requirements.Complete preventive maintenance and calibration activities according to established schedules (daily, weekly, monthly, and annual).Execute equipment and facility maintenance activities in accordance with approved procedures and work instructions.Assist with equipment installations, upgrades, and modifications.Troubleshoot mechanical, electrical, and pneumatic systems and support timely resolution of equipment and quality-related issues.Coordinate and assist with external contractors, vendors, and site service providers.Support change management activities for validated equipment, utilities, and facility systems.Maintain accurate and complete maintenance documentation and records.Follow all applicable safety policies, procedures, and regulatory requirements.Perform additional duties and special projects as assigned.Required Education & Experience
High school diploma, GED, or completion of a technical/trade school program required.Minimum of 2 years of facilities, maintenance, or engineering support experience in a cGMP-regulated manufacturing environment.Hands-on experience diagnosing, troubleshooting, and repairing mechanical, electrical, and pneumatic systems.Experience supporting manufacturing equipment, utilities, and facility infrastructure preferred.Communication Skills
Ability to read, interpret, and follow safety procedures, technical manuals, maintenance instructions, and SOPs.Strong written communication skills with the ability to complete maintenance records, reports, and documentation accurately.Ability to communicate effectively with employees, contractors, vendors, and cross-functional teams.Technical & Computer Skills
Proficiency with Microsoft Office applications and general computer systems.Ability to learn and utilize maintenance management software and electronic documentation systems.Basic mathematical skills, including the ability to perform calculations involving measurements, weights, volumes, and distances.Certifications & Licenses
Valid driver’s license required.Preferred Knowledge, Skills & Abilities
Understanding of facility systems, utilities, and building infrastructure.Knowledge of Building Management Systems (BMS), such as Siemens, Johnson Controls, or similar platforms.Strong understanding of cGMP, GMP, and FDA-regulated manufacturing environments.Experience using Computerized Maintenance Management Systems (CMMS), such as Maximo, BMRAM, or similar software.Ability to work independently with minimal supervision and manage multiple priorities effectively.Knowledge of applicable mechanical, electrical, biological, and workplace safety standards and practices.Demonstrated troubleshooting and repair skills for mechanical, electrical, and pneumatic equipment.Strong organizational and documentation skills with attention to detail.Effective verbal and written communication skills.Ability to collaborate with employees across multiple departments and organizational levels.Ability to function successfully in a highly regulated FDA-controlled environment.Professional discretion and ability to handle confidential information appropriately.
Physical Demands and Work Environment
The physical demands and work environment characteristics described below are representative of those that an employee may encounter while performing the essential functions of this position. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of the job.
While performing the duties of this position, the employee is regularly required to use hands and fingers to operate tools, equipment, and computer systems; communicate verbally and in writing; and observe and assess equipment and facility conditions. The employee frequently stands, walks, sits, reaches, bends, stoops, kneels, crouches, climbs ladders, and works in manufacturing and facility environments.
The position may require the ability to move, transport, or position materials, tools, and equipment weighing up to 50 pounds, with or without reasonable accommodation.
Specific vision abilities required for this role include the ability to read documents, technical diagrams, equipment displays, and computer screens, with corrective lenses if needed.
Work is performed in both office and manufacturing environments. The employee may be exposed to moving mechanical parts, chemicals, cleaning agents, equipment noise, varying temperatures, and other conditions typical of a cGMP-regulated manufacturing facility.
The noise level in the work environment is generally moderate but may vary depending on operational activities and equipment in use.
Read LessPurpose
The Production Technician I is responsible for developing and maintaining proficiency in human tissue manufacturing procedures and related support processes to execute and sustain the production schedule. This role requires strict adherence to FDA regulations, industry standards, and Good Manufacturing Practices (GMP).
Responsibilities
Complete assigned training on standard operating procedures (SOPs) by required deadlinesMaintain competency in aseptic technique and sterile field protocols through ongoing trainingManufacture finished products from human tissue using aseptic technique in compliance with SOPsApply good judgment to optimize tissue processing efficiency and maximize product yieldIdentify and report deviations and nonconformances to management and Quality AssurancePerform cleanroom and equipment cleaning, decontamination, calibration, and environmental monitoringDecontaminate, wrap, and autoclave reusable manufacturing supplies in accordance with SOPsAccurately and concurrently document manufacturing processes and support tasks in controlled recordsEnsure all documentation complies with GDP, SOPs, and regulatory requirementsReport to work on-site and on time for scheduled shifts, including mandatory overtime when requiredAttend all scheduled meetings, training sessions, and appointments as assignedMaintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures.Perform other duties as assigned
Skills
Ability to work independently and in a team environmentExcellent attention to detail and organizationExcellent written and verbal communicationHighest level of ethics and integrityAbility to lead and motivate the right behaviorsAbility to multi-task and work in a fast-paced environmentProficient in aseptic techniqueExcellent documentation accuracyProficiency in Microsoft OfficeAbility to follow SOPs and regulatory guidelines with precisionPhysical Requirements
Ability to work seated or standing for 8 – 10 hoursAbility to lift, push, pull or otherwise transport objects or weighing up to 25lbsQualifications/Requirements
High school diploma or equivalent requiredAt least 1 year of hands-on experience with aseptic technique requiredExperience working in an FDA-regulated environment preferredA higher level of education (such as an associate’s or bachelor's degree in a related field) may be considered in lieu of 1-3 years of required experienceClearance of favorable background investigation required
The compensation range listed reflects the full salary range for the position and is not indicative of the starting salary. Final compensation will be determined based on job-related factors, including experience, qualifications, and internal equity.
Read Less Purpose
The Document Control Specialist is responsible for administering, maintaining and updating the Quality System documentation records and files maintained in both internal controlled document locations and in the Electronic Quality Management System (EQMS). This position oversees the activities of personnel engaged in preparing controlled documentation, files, folders and reports, ensuring their completeness and accuracy and providing input regarding modification, revision and resubmission. Support activities related to the management of documentation archives. This position assists in overseeing and administrating employee training requirements within the EQMS. This role is responsible for ensuring the training systems are maintained that personnel training is performed, and that records are complete and up to date.
Responsibilities
Serves as the primary EQMS administrator, responsible for troubleshooting, user support and Jira ticketing managementManage Change Order requests for new/revised documentation in Electronic Quality Management SystemCreate, review and maintain Quality system documents. Provides guidance to departments implementing new or updated documentation.Oversee documentation activities to ensure the accurate implementation and maintenance of Quality System documentation records across all departments and facilitiesConduct monthly reviews of TAM webpage documents ensuring current revisions are posted for accuracy and complianceFacilitate periodic review of controlled documents to ensure content is current and up to date with current processesPerform closure and proper filing of Quality Event records, such as Nonconformances and DeviationsInitiate monthly review of regulations and standards in the external Document Management SystemMaintain the US GS1 database and oversee UDI code assignmentServes as a backup administrator for EQMS training activities such as employee set up and onboarding, managing training profiles, updating or issuing new training requirements, trending, and weekly reportingCoordinate and execute Management Reviews and Internal AuditsAssist in Validation of Software to support QA activitiesSupport and participate in other QA projects and activities as needed Maintain a working knowledge of FDA 21 CFR 820, ISO 13485, ISO Standards, cGMP/cGTP, FDA 21 CFR 1271, AATB standards, other relevant regulations/standards, and internal organizational policies and standard operating procedures.Maintain acceptable attendance and punctuality for scheduled work hours and meetings. Ensure completion of assigned tasks and responsibilities within defined timeframesFlexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessaryPerform other duties as assignedSkills
Ability to work independently and in a team environmentExcellent attention to detail and organizationExcellent written and verbal communicationHighest level of ethics and integrityAbility to lead and motivate the right behaviorsAbility to multi-task and work in a fast-paced environmentSelf-motivated with strong organization skills and ability to adhere to due dates/timelinesStrong technical writingProficiency in Microsoft OfficeQualifications/Requirements
Bachelors degree in Life Sciences or Biology, English or Communications, or related field, from an accredited college or university preferred.At least three (3) years of experience in medical device industry or a regulated manufacturing environment or related field required. Clearance of favorable background investigation required. Read LessPurpose
The Production Technician I is responsible for developing and maintaining proficiency in human tissue manufacturing procedures and related support processes to execute and sustain the production schedule. This role requires strict adherence to FDA regulations, industry standards, and Good Manufacturing Practices (GMP).
Responsibilities
Complete assigned training on standard operating procedures (SOPs) by required deadlinesMaintain competency in aseptic technique and sterile field protocols through ongoing trainingManufacture finished products from human tissue using aseptic technique in compliance with SOPsApply good judgment to optimize tissue processing efficiency and maximize product yieldIdentify and report deviations and nonconformances to management and Quality AssurancePerform cleanroom and equipment cleaning, decontamination, calibration, and environmental monitoringDecontaminate, wrap, and autoclave reusable manufacturing supplies in accordance with SOPsAccurately and concurrently document manufacturing processes and support tasks in controlled recordsEnsure all documentation complies with GDP, SOPs, and regulatory requirementsReport to work on-site and on time for scheduled shifts, including mandatory overtime when requiredAttend all scheduled meetings, training sessions, and appointments as assignedMaintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures.Perform other duties as assignedSkills
Ability to work independently and in a team environmentExcellent attention to detail and organizationExcellent written and verbal communicationHighest level of ethics and integrityAbility to lead and motivate the right behaviorsAbility to multi-task and work in a fast-paced environmentProficient in aseptic techniqueExcellent documentation accuracyProficiency in Microsoft OfficeAbility to follow SOPs and regulatory guidelines with precisionPhysical Requirements
Ability to work seated or standing for 8 10 hoursAbility to lift, push, pull or otherwise transport objects or weighing up to 25lbsQualifications/Requirements
High school diploma or equivalent requiredAt least 1 year of hands-on experience with aseptic technique requiredExperience working in an FDA-regulated environment preferredA higher level of education (such as an associates or bachelor's degree in a related field) may be considered in lieu of 1-3 years of required experienceClearance of favorable background investigation requiredThe compensation range listed reflects the full salary range for the position and is not indicative of the starting salary. Final compensation will be determined based on job-related factors, including experience, qualifications, and internal equity.
Read Less