Career Opportunities

Analytical Quality Control Chemist II

The Chemist II of Analytical Quality Control has responsibility of performing complex testing of raw materials and finished products, maintenance and calibration of analytical instruments in compliance with cGMP. The position will provide assistance to analytical quality control manager to meet projects timelines and improve laboratory compliance.

Primary Responsibilities

  • Perform routine/non-routine testing, both wet chemistry and instrumental analysis, according to SOPs, testing methods, protocols, compendia (USP EP/JP) etc with minimum supervision.
  • Participate in analytical method validation for intermediate precision study.
  • Involve testing of raw materials, APIs, finished products, stability samples, and cleaning verification samples, etc.
  • Proficient at HPLC/GC analysis
  • Document laboratory work according to cGMPs and SOPs 
  • Troubleshoot, calibrate and maintain instruments as required.
  • Prepare and label laboratory reagents, reference standards, or solutions according to SOPs.
  • Write SOP's, laboratory protocols and reports, memos and/or other interdepartmental correspondence
  • Initiate and resolve laboratory investigations.
  • Train and provide guidance to entry level QC personnel and be a subject matter expert in laboratory practices.
  • Perform peer review of analytical documentation.
  • Follow safety procedures when working in laboratory.
  • Understand and comply with cGMPs and other regulations. 
  • Maintain the laboratory in an organized and neat manner.

Qualifications

  • BS degree required, preferred in science degree. Require minimum of 3 years quality control working experience.
  • Familiar with fast paced contract manufacturing environment and be able to work under pressure while maintain high quality.
  • Experience working with potent, or cytotoxic materials preferred. 
  • Working experience with parenteral drug products preferred.
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Instrumentation and Controls Technician II

The role of the Instrumentation and Controls technician is to provide the necessary knowledge and skill sets needed to properly and efficiently calibrate, maintain, troubleshoot and repair CLI’s cGMP process, facility, and laboratory equipment and instrumentation. This position is also responsible for working across departments to coordinate the timely completion of routine and non-routine calibration and the maintenance, documentation of all activities per the required procedures and processes.

Under guidance of the Facilities Engineering Manager and/or the Instrumentation and Controls Engineer, this individual is primarily responsible for performing routine and non-routine calibration of CLI’s critical, non-critical, and safety related instruments used to support cGMP process manufacturing, packaging, facility and other material testing processes. CLI’s cGMP process manufacturing equipment includes but is not limited to: liquid filling equipment, autoclaving equipment, depyrogenation equipment, lyophilization equipment, vial washing equipment, isolators and other miscellaneous process support equipment. CLI’s laboratory equipment includes but is not limited to: temperature and humidity controlled stability chambers and chart recorders, timers, and temperature indicators.

Primary Responsibilities

  • The position requires a high level of instrumentation and controls knowledge, skills and experience in order to thoroughly assess any problems with the equipment and systems, identify the problems, make the necessary repairs and then complete all associated cGMP documentation needed to appropriately document the work performed (e.g. work orders, change controls, etc.). A high level of knowledge and skill utilizing tools such as multimeters, temperature measuring standards, humidity measuring standards, decade resistance simulators, pressure standards, etc. is required
  • This position requires effective communication skills needed to work across CLI departments (and associated department management) to coordinate routine and non-routine activities within the master production schedule, work closely with Operations personnel to obtain information needed to assess equipment problems in a courteous / professional demeanor, as well as coordinate and oversee the work of vendor technical personnel.
  • In addition, this position assists in establishing and maintaining any necessary procedures and processes required to perform routine calibration equipment and systems throughout the facilities. This includes but is not limited to establishing calibration procedures / tasks, establishing and maintaining appropriate calibration schedules and intervals, reviewing / enhancing calibration procedures when required and identifying improvements to existing calibration processes in order to ensure peak performance of the process equipment.
  • The position will also require participation in cross functional teams that may be required to identify assignable root causes for any product or equipment related deviations or anomalies, and then establish and implement the necessary corrective and preventive actions needed to ensure the incident or anomaly is prevented in the future.
  • Other essential functions this individual will need are as follows:
    • Perform all activities in compliance with CLI cGMP and safety policies, procedures and practices.
    • Responsible for conveying the Company’s attitude towards quality, policy and standard operating procedures, throughout the department.
    • Assist in supervising activities of self and contractors when appropriate.
    • Communicate with Directors, Managers, Supervisors, peers and subordinates. Notify management or other qualified personnel if specifications cannot be met and/or quality or safety is being compromised.
    • Operate tools such as PCs and various interface hardware and software to support automation platforms/components such as PLCs and HMIs.
    • Perform advanced level repairs and troubleshooting.
    • Develops and writes equipment calibration procedures.
    • Maintain calibration database as required.
    • Communicate if any safety equipment is not functional and if any employee does not practice proper safety procedures.
    • Exercise excellent technical, mechanical and control system aptitude / skills in order to accurately identify root causes for machine failures or break downs and the repair accordingly.
    • Adhere to company policies and procedures.
    • Read, understand and comply with SOP’s.
    • Read and understand technical information provided in equipment manuals and any associated electrical or mechanical drawings.
    • Able to read and understand PLC (programmable logic controller) control logic, as well as other configurable controllers such as VFDs, relay logic, etc.
    • Maintain work areas in a neat, organized and uncluttered state
    • Document all activities as required by SOP, Policy or other work instruction.
    • Deliver all services with a craftsman like manner and quality.
    • Overtime work may be required during standard shifts or on weekends to assure production schedules are met, as well as maintain PM schedules.
    • Work on other projects as requested by management.
    • Stay current with evolving plant technology.
    • Must be physically capable of climbing ladders, working with minute hardware, working in a lying position, working with arms extended overhead.
    • Must be physically capable of using a respirator and other personal protection devices/equipment.
    • Proper and safe operation of any powered hand tools, un-powered hand tools and machine shop equipment used in the expected normal course of duties.

Qualifications

  • High school diploma or equivalent.
  • Highly desirable: Associate’s Degree in Engineering Science or Engineering Technology or related discipline.
  • 5 years’ experience in a structured maintenance program; or equivalent combination of education and experience.
  • Knowledge of cGMP
  • Experience in a cGMP or other highly regulated environment required.
  • Must be able to work independently and have a high mechanical aptitude.
  • Effective verbal and written communication skills.
  • Able to maintain accurate and legible records.
  • Must be able to consistently demonstrate self-initiative to identify, research, and solve facility equipment and electrical problems involving complex variables.
  • Ability to read and interpret documents such as safety rules, standard operating procedures, operating and maintenance instructions, and procedure manuals.
  • Ability to write routine reports and correspondence.
  • Ability to perform mathematical calculations sufficient to perform the job. Skills must be sufficient to understand and evaluate basic engineering calculations such as for HVAC, piping, fluids, heat transfer, etc.
  • Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
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Maintenance Supervisor

The Maintenance Supervisor is responsible for the Preventive and Corrective maintenance of plant mechanical systems in a cGMP environment. Systems include USP grade Water and Steam systems, HVAC (includes HEPA Air Handlers), chillers, generators, boilers, and equipment that supports Aseptic Processes (Autoclave, Depyrogenation Oven, VHP Generators and Lyophilizer). The Facilities Manager is also responsible for overseeing the metrology and instrumentation areas to ensure that all equipment remains calibrated and in proper working order at all times.

This position will ensure that all maintenance and metrology/instrumentation tasks are performed in compliance with cGMP and applicable SOPs. Assists with performing equipment troubleshooting and recommends appropriate remediation. Coordinate with vendors, in-house managers and external equipment service providers to maintain facilities and instrumentation in support of all operations. Maintain cGMP compliance and a state of audit readiness at all times. Also works with Management team to resolve outstanding work orders related to equipment, facility and instrument issues.

The Maintenance Supervisor is responsible for tracking and prioritizing Work Orders related to Preventative Maintenance, Recurring Calibrations and Daily requests for Work Orders. The Maintenance Supervisor will also coordinate the inventory of critical spare parts required to keep all departments operating under normal conditions.

The Maintenance Supervisor will be required to wear the required clothing to perform job functions in an aseptic environment, comply with safety requirements, be on-call for emergencies, and periodically work off hours.

Primary Responsibilities

  • Coordinate the maintenance of all mechanical systems.
  • Coordinate the calibration and qualification of all instrumentation and related equipment.
  • Insure that equipment monitoring and proper documentation is performed.
  • Audit cGMP documentation of work performed.
  • Participates in cross functional teams to meet deadlines and achieve project objectives
  • Maintain spare parts inventories
  • Ability to interpret engineering drawings
  • Use applicable software such as MS Office, MS Project and Work Order software
  • Interact and provide direction to direct reports and service providers/vendors relevant to area of responsibility
  • Support any function of the other departments as necessary (e.g. Engineering and Validations)
  • Ensure that work is performed within established safety guidelines.
  • Insure that clean and orderly work areas are maintained.
  • Ability to write, revise and review relevant protocols and procedures.

Qualifications

  • Should have a minimum of a B.A. or B.S. in a technical field and/or equivalent degree, advanced degree preferable.
  • 5 to 10 years of Maintenance/Instrumentation Supervision experience in a regulated industry, preferable in a pharmaceutical environment is required.
  • Have the ability to troubleshoot equipment problems using a variety of tools and diagnostic instrumentation.
  • Ability to lift 50 pounds.
  • Familiarity with Pharmaceutical processing equipment – Steam Sterilizers, Depyrogenation Ovens, Lyophilizers, Water Systems, VHP Generators, Lab Equipment, Precision Scales, HEPA Air Handlers, Isolators and Water Treatment Systems.   
  • Familiarity with automated control systems and PLC interfaces
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Manufacturing Inspector & Labeler

The Inspector and Labeler position performs production activities including equipment and room preparations, inspection, labeling and packaging, collaborates effectively with other functional groups to ensure production goals are achieved and investigations are completed in a timely manner.

Primary Responsibilities

  • Line clearances, cleaning, preparing of rooms and equipment.
  • Operate and maintain inspection, labeling, and packaging areas and equipment.
  • Maintain records and a clean environment to comply with regulatory requirements.
  • Read, understand, and comply with Good Manufacturing Practices and Standard Operating Procedures.
  • Review/update current SOPs as well as write new SOPs if required.
  • Lead troubleshooting and process improvement activities including corresponding documentation activities.
  • Review completed production documentation for quality and compliance.

Qualifications

  • High school education or equivalent.
  • Minimum of 3 years of experience in an aseptic manufacturing environment.
  • Must be familiar with a variety of production equipment.
  • Team player committed to quality and working effectively with others.
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Manufacturing Operator

The role of the manufacturing operator is to perform production activities including Equipment preparation, Formulation, Filling, Inspection, and Packaging. Collaborates effectively with other functional groups to ensure production goals are achieved and investigations are completed in a timely manner.

Qualifications

  • High school education or equivalent.
  • BS in Biology, Microbiology, Chemistry, Bio-Tech or Engineering preferred (current students may apply).
  • Experience in an aseptic manufacturing environment preferred.
  • Must be familiar with a variety of production equipment.

Primary Responsibilities

  • Line clearances, cleaning/sanitization, cleaning, preparing and sterilization of fill equipment, sterilization of components, operation of aseptic filling equipment, filter testing, operation vial washing equipment
  • Operate and maintain production equipment.
  • Weigh, measure and check raw materials to assure batches manufactured contain proper ingredients and quantities.
  • Execute validation protocols for processes and equipment.
  • Maintain records and a clean environment to comply with regulatory requirements.
  • Read, understand, and comply with Good Manufacturing Practices and Standard Operating Procedures.
  • Review/update current SOPs as well as write new SOPs.
  • Lead troubleshooting and process improvement activities including corresponding documentation activities.
  • Review completed production documentation (batch records, log books, etc.) for quality and cGMP compliance.
  • Initiate appropriate action when process deviations occur.
  • Perform on job training for new and developing operators.
  • Other duties as assigned by leadership team.
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Quality Assurance Specialist / Sr. Quality Assurance Specialist

The Quality Assurance Senior Specialist ensures complicance with regulations governing the manufacturing, testing, warehousing, and distribution of pharmaceutical drug products.  This position will help to further develop Coldstream's overall cGMP compliance and to support the day-to-day performance of cGMP compliance throughout the company.  The position will report directly to the Quality Assurance Manager.

Primary Responsibilities

  • Experience with conducting GMP investigations
  • Strong knowledge of GMP regulations, guidance, and general compliance expectations

Qualifications

  • Bachelor's degree in a scientifi discipline or equivalent with 5+ years relevant industry experience in a cGMP/FDA regulated environment with at least 3 years in QA
  • Good understanding of sterile manufacturing is required
  • Knowledge of cGMP and applicable FDA regulations
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Senior Validation Specialist

The Senior Validation Specialist reports directly to the Validation Supervisor and will perform specific assigned duties and undertake project work within the Validation Department.  

Primary Responsibilities

  • Write, schedule, plan, manage and execute validation and qualification protocols
  • of manufacturing, packaging, laboratory, utility systems and other equipment in accordance with 
  • current Good Manufacturing Practices (cGMPs), Good Engineering Practices (GEP) and change 
  • control. 
  • Directly interact with Coldstream Clients and regulatory agencies
  • Responsible for managing validation department in the absence of the Validation Supervisor
  • Responsible for reviewing executed qualification protocols and drafted documents by other Validation staff
  • Author summary reports for qualification protocols.
  • Act as technical interface between the company and 3rd parties for discussions surrounding the on-site validation activities.
  • Coordinate and interface with Operations, Technical Services, Facility Engineering, Microbiology, and Quality Assurance groups to assure successful project execution.
  • Lead qualification activities and timelines for equipment purchased for manufacturing purposes. Coordinate order timelines and equipment requirements with Technical Services group.
  • Represent validation at project team meetings and provide expert validation advice.
  • Perform routine duties as required in order to ensure the timely generation of accurate data and information.
  • Independently design, plan and manage own studies.
  • Maintain and develop state of the art knowledge applicable to existing and future validation processes and maintain up-to-date knowledge on regulatory expectations.
  • Lead investigations related to validation discrepancies and assure thoroughness of investigation, documentation and closure. Implement preventive/corrective actions as necessary.
  • Conduct periodic validation reviews of equipment, facilities, utilities, and sterilization cycles.
  • Author assigned Standard Operating Procedures (SOPs) for Validation department.

Qualifications

  • Bachelor’s degree in engineering or science required
  • Minimum of five years experience working in a GMP environment, with a minimum of three years of validation experience. 
  • Must have excellent technical writing skills and problem solving ability.
  • Sound knowledge, understanding, and application experience of quality management systems such as Deviations, CAPAs, Change Controls, etc.
  • Must be independent, detailed oriented, have the ability to manage own time, be flexible, tactful, and team oriented, balancing as appropriate.
  • Validation experience with manufacturing facilities/areas (e.g. multi-product facility, warehouse, cold rooms, autoclaves, depyrogenation ovens)
  • Strong computer and communications skills
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