McGuff 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 engineering
- Review and approve variances, design control proposals and change orders
- Implementing departmental policies, programs and procedures within the engineering group
- Maintain operational status of manufacturing equipment clean rooms, autoclaves, boilers, utilities and processes in an aseptic manufacturing environment
- Plan, 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 injectables
- Some 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 errors
- Working 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 equipment
- Debugging and troubleshooting
- Mentoring engineer and technician staff
- PM and CM service new equipment
- Other 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-ables
- Experience with regulated industry Process Development and Regulatory requirements.
- Familiar with Chemistry, Engineering and Manufacturing operations related to inject-able drugs
- Knowledge 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 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
- 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.
Job Type: Full-time
Pay: $32.00 - $80.00 per hour
- 401(k) Matching
- Dental Insurance
- Health Insurance
- Paid Time Off
- Vision Insurance
- BioPharmaceutical / BioMed Engineering: 8 years (Required)
- Inject-able Drug Product: 4 years (Required)
- aseptic / sterile manufacturing: 4 years (Required)