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BioPharmaceutical Validation Specialist

McGuff Family of Companies

BioPharmaceutical Validation Specialist

Santa Ana, CA
Full Time
Paid
  • Responsibilities

    Job Description

     

    JOB DETAILS McGuff Pharmaceuticals, Inc. in Santa Ana, CA is looking for a Quality/Validation Engineer in Santa Ana, CA. This engineer must have experience working with aseptic fill/finish lines in a manufacturing environment.

    The Engineer will develop, plan, coordinate and execute qualification / reqauification projects associated with drug product sterile/aseptic 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/PPQ 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
    • 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)
    • 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.

    Company Description

    We are a family company that has been in business for 35+ years located in Santa Ana California. We have three companies located in Southern California who are all seeking dedicated, hard working, candidates who bring a smile to work every day. History: Apollo 16 astronauts were walking on the moon when Gilbert J. McGuff (Gil), decided to supplement his income by supplying innovative medical products to Bariatric physicians and patients. Gil founded the McGuff Company (McGuff) in 1972 and became its sole proprietor. While working fulltime and managing McGuff after hours, Gil still found the time to instill an entrepreneurial spirit in all three of his sons. Each son eventually started his own business. In 1979 Gil was approaching retirement and sold McGuff to his youngest son Ronald M. McGuff (Ron) who had been working for Procter & Gamble. Gil was hired by Ron as the first company employee and both Ron and Gil worked hard together to build upon McGuff’s early success as a nation-wide distributor of medical products. Ron’s first day working for the new McGuff was April 1st 1979. A new direction was taken to align the company with the medical profession’s leading innovators in complementary medicine. Understanding the needs of these extraordinary physicians became paramount for McGuff. The McGuff team visited complementary physicians around the country to understand the unique therapies provided to patients. McGuff molded itself to provide these physicians with the unique products they desired. McGuff was incorporated in 1982 and remains a family owned company. McGuff developed associations with the industry’s leading manufacturers to bring quality drugs and medical devices at discounted prices to complementary physicians. McGuff developed a number of services and products to address specific needs of physicians and patients. Among these innovations; Ascorbic Acid injection with EDTA (replacing Monothioglycerol), Osmolarity Software, EDTA dose calculating software, IV administration sets with internal filters, and McGuff/physician computerized inventory control, etc. The McGuff Company evolved to meet changing needs of complementary physicians and new therapies that they have developed. McGuff’s reputation for quality products, excellent customer support and regulatory integrity became known to a broad spectrum of physicians in the United States and around the world. For more information about each of the specific companies please read below: McGuff Pharmaceuticals, Inc. McGuff, anticipating profound changes to the regulation of injectable drugs, chose to launch a second wholly owned subsidiary, McGuff Pharmaceuticals, Inc. (MPI) in 2002. McGuff Pharmaceuticals, Inc. is a Food and Drug Administration inspected sterile fill manufacturer that maintains a tradition of quality and a core competency in both current Good Manufacturing Practices (cGMP), representing a unique combination for any pharmaceutical manufacturer. MPI sustains McGuff’s efforts to assure physicians a steady supply of FDA approved drugs through its own drug development program. MPI also provides contract manufacturing organization (CMO) services, contract development and manufacturing organization (CDMO) services and is international in it scope. MPI continues the McGuff tradition of providing personalized services, great customer care and the knowledge to be a valued member of any CMO or CDMO team. MPI maintains offices in the United States and Canada Website: www.mcguffpharmaceuticals.com