Skip to Main Content
← Back to Jobs

Aseptic Manufacturing Process Engineering Manager/Supervisor

McGuff Family of Companies Orange County ,CA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description: Job DetailsMcGuff Pharmaceuticals, Inc. currently has full-time openings for a BioPharmaceutical Aseptic Process Manufacturing Senior Engineer within our Aseptic Manufacturing Engineer group located in Santa Ana, CA. This position reports directly to the Plant Manager. The Senior Process Engineer will work with the Plant Manager to develop and optimize processes as well as execute tech, facilities and equipment transfers and scale-up, oversee and be responsible for assigned Engineering projects for McGuff Pharmaceuticals. Responsibilities extend to all activities related to facility expansion, Manufacturing equipment/process design, commissioning, installation, maintenance on equipment, capital, and drive process efficiency while adhering, creating, updating and enforcing Standard Operating Procedures in cGMP. support process development and optimization, manufacturing line support, equipment development, tooling, process transfers and new product commercialization initiatives. The Engineer will also focus on high impact projects that drive continuous improvement in the Santa Ana sterile filling facility. The Engineer oversee other engineers and technicians and collaborate with cross-functional teams, ensure that all applicable project objectives, policies, procedures, state and federal laws are met. Essential Functions and Duties shall include:Optimize manufacturing processes, including using engineering methods (e.g., SIX Sigma and LEAN methods) for continuous process improvement and/or re-design/design of equipment, tools, fixtures, etc. to improve manufacturing processes, employing technical design skills.Develop complex protocols and tests (e.g. IQ/OQ/PQ) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports.Analyze and resolve moderately complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.Responsible for coordinating and implementing activities related to future and on going manufacturing process engineeringReview and approve variances, design control proposals and change ordersImplementing departmental policies, programs and procedures within the engineering groupMaintain operational status of manufacturing equipment clean rooms, autoclaves, boilers, utilities and processes in an aseptic manufacturing environmentPlan, organize and lead engineering projects; including identifying goals, objectives, methods, resources, and routes of communication needed to carry out responsibilities and dates for completion of engineering activities and tasks.Organizing resources to achieve the goals within a defined timeline.Establishing effective communications and guiding project members to accomplish stated project objectives.Meeting strategic objectives for company growth.Support both Processes Development and Product Development for generic sterile injectablesSome preparation of engineering documentation for equipment procurement (e.g. URS, DDS, FAT, SAT) as well as equipment installs (e.g. IQ, OQ) and process validations (e.g. Cleaning Qualifications, Process Qualifications)Develop and define product specifications, procedures, and controls.Provide technical guidance to department staff as required in areas related to engineering and process development such as characterization, pre-formulation, formulation and process development, scale-up, preparing clinical supplies, technology transfer, manufacturing scale-up, and formulation and process improvement.Troubleshooting, failure analysis and corrective action of design and processing errorsWorking with Manufacturing, Quality Systems and other personnel to ensure anticipated activities and outputs are planned and effectively executed.Coordinating product and process engineering, qualification, and validation studies as needed.Assurance that product development activities comply with all regulatory and compliance requirements (e.g. NDA, ANDA, IND requirements)Working with customers and clients to define and implement contract manufacturing opportunities to meet customer requirements and exceed expectations.As assigned by the Plant Manager, working with customers and other employees to develop, implement and control clinical trials.Manage Filling suite, oversee fill line equipmentDebugging and troubleshootingMentoring engineer and technician staffPM and CM service new equipmentOther duties as assigned. Minimum Qualifications shall include:Bachelor’s degree (B.A./B.S.) of Science in BioMecial, Chemical, Engineering or related field or equivalent; Advanced technical Masters of Science or PhD degree is a plus.Minimum of 8 years relevant BioPharmaceutical/BioMedical industry working experience.Minimum 4 years experience working in an aseptic inject-able drug manufacturing environment and directly with inject-ablesExperience with regulated industry Process Development and Regulatory requirements.Familiar with Chemistry, Engineering and Manufacturing operations related to inject-able drugsKnowledge of state, federal, and international regulatory requirements and submissions (Federal marketing application such as NDA, ANDA, IND, PMA, etc…) for Pharmaceutical (or medical device) products.Thorough understanding and application of technical principles, theories, and concepts related to product, process, technology development and evaluation.Understanding and working knowledge of chemical and physical properties of pharmaceutical active ingredients and excipients as they relate to formulation, process and drug delivery.Working and theoretical knowledge of pharmaceutical ingredients, manufacturing, processing and testing equipment, advanced technologies, and delivery systems.Ability to develop formulations, processes, and pharmaceutical products.Working understanding of statistical techniques including experimental design.Knowledge of FDA requirements (cGMP and marketing applications)Computer literate and familiar with computerized inventory monitoring, tracking and control systems.Type a minimum of 45 words per minute. What Is 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 skillsHigh 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 changeResults driven and a hands on approach to completion of assigned tasks 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 75 pounds. 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 m

McGuff Family of Companies

Why Work Here?

Awesome CEO, Great Benefits, Room for growth

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

Address

4040 W Carriage Dr
Orange County, CA
USA

Website