This role requires experience at a PSM or API manufacturing facility. Essential Duties and Responsibilities. Budgets for maintenance function and ensures that expenses are within the budget. Ensures of smooth functioning of Engineering and Maintenance (Mechanical, Electrical, Instrumentation Facilities ,Utilities and Water System. Ensures 100 % availability of Utilities with minimum down time to fulfill the Process requirement. Work Order managem...
Our client is seeking a highly motivated and experienced individual for a Director, Validation to provide leadership for all validation activities. The Director, Validation will be responsible for all clinical and commercial manufacturing support through facilities, equipment, filter, cleaning, and manufacturing process validation, support commissioning and qualifications of capital projects, computer systems qualification, and oversite of the en...
The Process Engineer reports directly to the VP, North America Manufacturing. He/she interfaces with both management and union personnel from various levels. They also work closely with manufacturing, understanding the processes and the cause-and-effect relationship of the manufacturing cycle. What we’re looking for. Education: Bachelor’s Degree in Chemical Engineering or a related field required. Experience. Minimum of five (5) years of related ...
Our pharmaceutical client is looking for a hands-on Senior Manufacturing Engineer to lead new equipment and process improvement initiatives. You will be at the forefront and expert of designing and procuring new manufacturing equipment. If you thrive wokring in a fast-paced, highly collaborative environments, this role may be the one for you. RESPONSIBILITIES. Lead efforts to monitor and optimize the performance of manufacturing equipment ensurin...
Our client is hiring a Director of Quality Assurance as they grow in the clinical and commercial space. The ideal candidate will have clinical GMP and/or commercial GMP experience in the pharmaceutical industry. Duties and Responsibilities. Leads the Quality Assurance (QA) Department, including hiring and mentorship to the team. Leads implementation and continuous improvement of the company’s quality systems and facility validation. Creates produ...
2542 Director of Process Development and Formulation. This position is responsible for leading and empowering the Development Team in taking Company’s’ drug product candidates from formulation development through process development, scale-up, optimization, process characterization, clinical production, and technical transfer to the commercial manufacturing site. The successful candidate will thrive in a highly collaborative matrix team environme...
Head of Maintenance. Our client, a global leader in the development and manufacturing of generic injectable and inhalation products is looking for a strong leader and communicator that will bring experience working in a PSM environment. Essential Duties and Responsibilities. Budgets for maintenance function and ensures that expenses are within the budget. Ensures of smooth functioning of Engineering and Maintenance (Mechanical, Electrical, Instru...
Our client, a well-established, pharmaceutical organization is hiring an Associate Director of Quality Assurance (Manufacturing). This role will be a leader in an organization that continues to grow and establish themselves as a global leader. Responsibilities include, but are not limited to. Support the continuous improvement of manufacturing quality systems and processes. Provide QA oversight for all manufacturing operations. Review and approve...
Our pharmaceutical client is seeking a hands on Senior automation engineer II that has experience with GAMP5 along with designing, programming, monitoring and maintenance of production and facilities process automation systems. If you want to be a part of a fast, stable and growing organization, this role might be the one for you. Responsibilities. Design, develop, and implement automated systems, including software, hardware, and processes. Anal...
This role is an exciting opportunity to join a medical device company in San Diego who is making innovative products for patients. The Customer Operations Specialist will support the onboarding of customers, tracking of payments, and follow up of past-due payments. Key Accountabilities. Demonstrate a deep understanding of hospital procurement processes and IDN workflows, including vendor onboarding, purchase order management, invoicing, and payme...
Our client is seeking a Associate Director of Capital Projects who will be responsible for the strategic planning, execution, and oversight of capital projects. This role will provide leadership for project management, engineering design, procurement, construction, and validation of facilities, utilities, and manufacturing equipment. If you are someone who thrives in highly technical environment, this role might be the one for you. Responsibiliti...
Data Integrity and eCompliance Specialist. Key responsibilities. Data Integrity Compliance Officer (DICO), lead gap assessments of new and existing systems/practices. perform DI risk assessments for identified gaps. perform DI Audits of site. provide timely update on DI plan to Central DICO. and ensure site team is trained on DI aspects and requirements. To define validation strategy and review CSV deliverables for Site IT projects e.g. URS, FRS,...
