21 days old

Senior Validations Engineer

McGuff Pharmaceuticals, Inc.
Santa Ana, California 92704
  • Job Type
    Employee, Contract
  • Job Status
    Full Time
  • Shift
    1st Shift

Job Details

McGuff Pharmaceuticals, Inc. in Santa Ana, CA is looking for a Biopharmaceutical Quality Engineering and Validation Engineer (QEV) in Santa Ana, CA. This engineer must have experience working with aseptic filling lines in a manufacturing environment.

This position is potentially a contract role lasting about 9 - 12 months or full time based off business needs, to be determined.

The Engineer will develop, plan, coordinate and execute qualification projects associated with drug product sterile contract manufacturing, aseptic processing, filling, and packaging. The Engineer shall have experience with the qualification of facilities and scale-ups, pharmaceutical manufacturing equipment/systems, sterilization processes, sterile filling processes, cleaning processes, environmental room monitoring, media fills, and process validation runs. The candidate should have experience with single use technology, including sterile filter assembly qualifications. The Quality Engineer will be capable of executing equipment IQ/OQ/PQ and process validations as required. In addition, the Quality Engineer will also assist, in a team based approach, the development and improvement of processes to ensure such processes meet McGuff Pharmaceutical’s high standards of process capability, reliability, and repeatability.

The Quality Engineer will be capable of coordinating and executing process validations and associated system operational needs including, but not limited to, equipment and computer system Installation and Operation Qualifications (IQ/OQ) including temperature mapping, Performance Qualification (PQ) of Utilities, Sterilization and Decontamination Systems, Process Performance Qualification (PPQ), and full process validation documentation. Duties may also include assisting with and evaluating specification development, equipment procurement, operation and maintenance procedure development, and qualifying raw materials, in-process materials and finished goods, as required. The Quality Engineer shall ensure McGuff processes are compliant with cGMP requirements.

Essential functions and duties shall include:

  • Ensure manufacturing processes are valid and controlled as implemented.
  • Develop and generate written qualification/validation protocols and reports while project deliverables consistently meet established project timelines
  • Capable of coordinating and executing all process validations and associated system operational needs including, but not limited to, equipment Installation and Operation Qualifications (IQ/OQ), process Performance Qualification (PQ), full process validation documentation
  • Coordinate with process engineer, quality engineer, and technical teams for Process Validation (PPQ) protocols, execution and final reports.
  • Perform various testing procedures as needed for process inputs, outputs and parameters, such as, temperature monitoring, TOC analysis, LAL, environmental monitoring, bioburden testing, sterility testing, chemical analysis, physical analysis, etc… according to written procedures (SOPs).
  • Conduct routine project meetings and generate meeting minutes and action items to ensure project objectives and milestones are reached.
  • Develop and document written SOPs, as required, for current Good Manufacturing Practices (cGMP).
  • Implementing document changes and control procedures.
  • Conduct QA investigations and follow-up
  • Effectively participate in Quality by Design, continuous improvement initiatives and engineering quality processes.
  • Plan, implement, manage and control qualification and validation of manufacturing processes
  • Assisting, coordinating, performing and scheduling material qualifications.
  • Participate in Risk Analysis (FMECA’s), as assigned
  • Assist with process development for targeted products (under a team approach to product/process development).
  • Qualification and review of maintenance procedures and schedules for process equipment Troubleshooting and corrective action of processing deviations
  • Other duties as assigned.

Minimum qualifications shall include:

  • Bachelor’s degree (B.A./B.S.) of Science in Engineering, Chemistry or related field or equivalent; Advanced technical Masters of Science or PhD degree is a plus.
  • Minimum of 2 years relevant industry experience in a Quality or Engineering capacity with direct experience in process validation. Prefer minimum of 1-2 years relevant industry experience with a portion of that experience in manufacturing of sterile injectable drugs via aseptic processing.
  • Proficient with computers and related software (Microsoft Office Professional)
  • Ability to lead qualification efforts for equipment purchased or modified (FAT, SAT, IQ, OQ, PQ).
  • Familiarity with related GMP procedures and requirements. Including knowledge of appropriate Quality Systems and cGMP requirements (FDA, EU, ICH) with the ability to assess compliance risks.
  • Familiar with data acquisition systems and protocols. Prefer proficiency with specific data acquisitions systems such as Kaye Validator.
  • Versed in the proper use of statistical techniques and sampling plans.
  • Typing and office based skills
  • Excellent oral and written communication skills.
  • Ability to work independently and as a team member.
  • Ability to manage multiple concurrent tasks / studies.
  • High energy, enthusiastic self-starter who can work with minimal supervision.
  • Well organized and detail oriented.
  • Prefer working knowledge of ISO 9000 requirements.
  • Computerized calibration monitoring, tracking and control systems

What will be expected of you:

  • Appropriate professional demeanor.
  • Acquire knowledge of and assure compliance to corporate policies and procedures.
  • Ability to work with others.
  • Possess excellent communication skills.
  • Work with all McGuff employees to foster and promote quality.
  • Excellent customer skills
  • High regard for Trust, Integrity, Honesty, Ethics, Innovations and Safety in self and others.
  • High sense of Responsibility, Ownership, Accountability.
  • Capable of Flexibility in work requirements/conditions and willingness to embrace change
  • Results driven and a hands on approach to completion of assigned tasks
  • Comply with all McGuff Policies and Procedures

Physical requirements:

  • Position requires bending, squatting, climbing, and reaching above shoulder level. You must be able to comfortably be able to do so.
  • Position requires sitting, standing, walking, handling and manipulating objects (manual dexterity and fine finger movement).
  • Position will require repetitively lifting/carrying up to 50 pounds and manipulating upwards of 200 lb.

Why work for McGuff Family Companies, Inc.?

At McGuff Family Companies, Inc., we offer excellent compensation and benefits programs that reflect our goal to be a competitive and supportive employer. McGuff provides a comprehensive benefits package that includes medical, dental, vision and 401K retirement plans. In addition McGuff values its employee’s and their life outside of work too, which is why we offer all employees 11 paid days off per year!

Not to mention, we are growing fast and new opportunities emerge every day. McGuff offers a supportive setting where you can take control of your career while still enjoying the mentorship to develop new skills in an environment where you have an opportunity to thrive.

Want to learn more? Submit your resume now.

Requirements

Essential functions and duties shall include:

  • Ensure manufacturing processes are valid and controlled as implemented.
  • Develop and generate written qualification/validation protocols and reports while project deliverables consistently meet established project timelines
  • Capable of coordinating and executing all process validations and associated system operational needs including, but not limited to, equipment Installation and Operation Qualifications (IQ/OQ), process Performance Qualification (PQ), full process validation documentation
  • Coordinate with process engineer, quality engineer, and technical teams for Process Validation (PPQ) protocols, execution and final reports.
  • Perform various testing procedures as needed for process inputs, outputs and parameters, such as, temperature monitoring, TOC analysis, LAL, environmental monitoring, bioburden testing, sterility testing, chemical analysis, physical analysis, etc… according to written procedures (SOPs).
  • Conduct routine project meetings and generate meeting minutes and action items to ensure project objectives and milestones are reached.
  • Develop and document written SOPs, as required, for current Good Manufacturing Practices (cGMP).
  • Implementing document changes and control procedures.
  • Conduct QA investigations and follow-up
  • Effectively participate in Quality by Design, continuous improvement initiatives and engineering quality processes.
  • Plan, implement, manage and control qualification and validation of manufacturing processes
  • Assisting, coordinating, performing and scheduling material qualifications.
  • Participate in Risk Analysis (FMECA’s), as assigned
  • Assist with process development for targeted products (under a team approach to product/process development).
  • Qualification and review of maintenance procedures and schedules for process equipment Troubleshooting and corrective action of processing deviations
  • Other duties as assigned.

Minimum qualifications shall include:

  • Bachelor’s degree (B.A./B.S.) of Science in Engineering, Chemistry or related field or equivalent; Advanced technical Masters of Science or PhD degree is a plus.
  • Minimum of 2 years relevant industry experience in a Quality or Engineering capacity with direct experience in process validation. Prefer minimum of 1-2 years relevant industry experience with a portion of that experience in manufacturing of sterile injectable drugs via aseptic processing.
  • Proficient with computers and related software (Microsoft Office Professional)
  • Ability to lead qualification efforts for equipment purchased or modified (FAT, SAT, IQ, OQ, PQ).
  • Familiarity with related GMP procedures and requirements. Including knowledge of appropriate Quality Systems and cGMP requirements (FDA, EU, ICH) with the ability to assess compliance risks.
  • Familiar with data acquisition systems and protocols. Prefer proficiency with specific data acquisitions systems such as Kaye Validator.
  • Versed in the proper use of statistical techniques and sampling plans.
  • Typing and office based skills
  • Excellent oral and written communication skills.
  • Ability to work independently and as a team member.
  • Ability to manage multiple concurrent tasks / studies.
  • High energy, enthusiastic self-starter who can work with minimal supervision.
  • Well organized and detail oriented.
  • Prefer working knowledge of ISO 9000 requirements.
  • Computerized calibration monitoring, tracking and control systems

What will be expected of you:

  • Appropriate professional demeanor.
  • Acquire knowledge of and assure compliance to corporate policies and procedures.
  • Ability to work with others.
  • Possess excellent communication skills.
  • Work with all McGuff employees to foster and promote quality.
  • Excellent customer skills
  • High regard for Trust, Integrity, Honesty, Ethics, Innovations and Safety in self and others.
  • High sense of Responsibility, Ownership, Accountability.
  • Capable of Flexibility in work requirements/conditions and willingness to embrace change
  • Results driven and a hands on approach to completion of assigned tasks
  • Comply with all McGuff Policies and Procedures

Physical requirements:

  • Position requires bending, squatting, climbing, and reaching above shoulder level. You must be able to comfortably be able to do so.
  • Position requires sitting, standing, walking, handling and manipulating objects (manual dexterity and fine finger movement).
  • Position will require repetitively lifting/carrying up to 50 pounds and manipulating upwards of 200 lb.

Why work for McGuff Family Companies, Inc.?

At McGuff Family Companies, Inc., we offer excellent compensation and benefits programs that reflect our goal to be a competitive and supportive employer. McGuff provides a comprehensive benefits package that includes medical, dental, vision and 401K retirement plans. In addition McGuff values its employee’s and their life outside of work too, which is why we offer all employees 11 paid days off per year!

Not to mention, we are growing fast and new opportunities emerge every day. McGuff offers a supportive setting where you can take control of your career while still enjoying the mentorship to develop new skills in an environment where you have an opportunity to thrive.

Want to learn more? Submit your resume now.

Categories

Posted: 2020-10-09 Expires: 2020-11-08

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Senior Validations Engineer

McGuff Pharmaceuticals, Inc.
Santa Ana, California 92704

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