BioPharmaceutical Validation Specialist
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:
MINIMUM QUALIFICATIONS SHALL INCLUDE:
WHAT WILL BE EXPECTED OF YOU:
PHYSICAL REQUIREMENTS:
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