Maintenance Mechanic
14 days ago
Saint Paul
Job Description Position Summary: The objective of this role is to improve quality within production to meet our customers' needs and expectations. The Process Quality Engineer will focus on process and equipment improvements, develop bi-lingual manufacturing records, and attack quality system failures using effective root cause analysis methods. Additionally, this role will concentrate on continuous improvement through the implementation of effective Corrective and Preventive Actions (CAPA). The Process Quality Engineer will play a key role in ensuring that products meet industry standards, regulatory requirements, and internal quality objectives, while promoting a culture of compliance and continuous improvement across the organization. The Process Quality Engineer will lead the process manufacturing record development, assist with equipment qualification, and training of employees on manufacturing processes and procedures. Key Responsibilities: * Lead the bi-lingual (English and Spanish) development of manufacturing and packaging records. * Assist in quality-related problem-solving and root cause analysis in manufacturing to prevent recurrences. * Assist in execution of process validation, equipment qualification, and cleaning validation activities. * Participate in the investigation of technical issues, status of testing, and the establishment of procedures and CAPA to ensure product quality and regulatory compliance. * Operate independently, representing the quality organization in major meetings to resolve key issues and plan work. * Identify and analyze quality problems in production and testing, leading the problem-solving process to root cause determination and evaluating the effectiveness of implemented actions. * Update and write bi-lingual SOPs validation protocols, conduct internal audits. * Ensure compliance with company policies, procedures, and quality standards, including Good Manufacturing Practices (cGMP), safety, and environmental regulations. * Participate in safety, GMP, and other company-required training sessions. Required Skills/Abilities: * Must be proficient in speaking and writing both English and Spanish. * Strong knowledge of quality assurance methods, tools, and relevant manufacturing processes. * Experience with quality management software and systems (e.g., CAPA, FMEA, Statistical Process Controls). * Experience developing and writing manufacturing and packaging batch records, validation and qualification protocols. * Excellent analytical, critical thinking, and problem-solving skills. * High ethical standards, integrity, and professional behavior. * Excellent communication, problem-solving, and organizational skills. Ability to work independently and collaboratively within a fast-paced, cross-functional environment. * Strong proficiency in Microsoft Office Suite (Excel, Word, PowerPoint). * Ability to multitask and adapt to a flexible schedule. Required Education and Experience: * Bachelor's degree in Engineering. * 3-5 years of experience in pharmaceuticals or cosmetics. * Strong knowledge of quality systems (GMP, FDA, ISO 9001, regulations), personal care and cosmetic industry standards, and regulatory compliance. Preferred Education and Experience: * Master's degree in Engineering or related field preferred. * 1-2 years of experience in pharmaceuticals or cosmetics with a master's degree. * ASQ Certified Quality Engineer (CQE) certification is a plus. Company DescriptionW3Global was established in 2006 in Fremont, CA with a vision: simplify the recruiting process and develop an industry-disrupting platform to connect candidates with clients. Our cutting-edge Applicant Tracking System enables us to find the right person for the right job, creating value for job seekers and employers. While W3Global initially focused on IT staffing, we have expanded the business to serve many other industries, including accounting and finance, legal, engineering, human resources, government and more. We’re proud of the investments we’ve made in our team, having grown from four to 1000 employees and evolving into one of the leading recruitment and staffing solution providers in the industry. Our recruiters and account managers are passionate about connecting qualified professionals with the right positions in small, medium, and large companies. Our Services W3Global understands the natural ups and downs of an organization’s staffing needs. We are continuously adapting to industry and economic changes to find the right candidates. We specialize in placing permanent, direct, contract, and temporary positions for companies of any size. Our recruiting services include sourcing, recruiting, screening, interview management, salary negotiations, training, and onboarding. We are committed to helping organizations redefine their recruitment process by delivering our SaaS-based proprietary application tracking system software. Our Expertise W3Global has been delivering staffing solutions for nearly two decades; we know which recruiting strategies work best. Our expert team is committed to developing a customized solution to fit your company’s unique needs. As a W3Global client, you’ll also receive personalized assistance from a seasoned team of staffing specialists. We are committed to providing both technical support and industry expertise to simplify the hiring process. We know that your time matters. W3Global will help you streamline the hiring process, getting it done and getting it right.W3Global was established in 2006 in Fremont, CA with a vision: simplify the recruiting process and develop an industry-disrupting platform to connect candidates with clients. Our cutting-edge Applicant Tracking System enables us to find the right person for the right job, creating value for job seekers and employers. While W3Global initially focused on IT staffing, we have expanded the business to serve many other industries, including accounting and finance, legal, engineering, human resources, government and more.\r\n\r\nWe’re proud of the investments we’ve made in our team, having grown from four to 1000 employees and evolving into one of the leading recruitment and staffing solution providers in the industry. Our recruiters and account managers are passionate about connecting qualified professionals with the right positions in small, medium, and large companies.\r\n\r\nOur Services\r\nW3Global understands the natural ups and downs of an organization’s staffing needs. We are continuously adapting to industry and economic changes to find the right candidates.\r\n\r\nWe specialize in placing permanent, direct, contract, and temporary positions for companies of any size. Our recruiting services include sourcing, recruiting, screening, interview management, salary negotiations, training, and onboarding.\r\n\r\nWe are committed to helping organizations redefine their recruitment process by delivering our SaaS-based proprietary application tracking system software.\r\n\r\nOur Expertise\r\nW3Global has been delivering staffing solutions for nearly two decades; we know which recruiting strategies work best. Our expert team is committed to developing a customized solution to fit your company’s unique needs.\r\n\r\nAs a W3Global client, you’ll also receive personalized assistance from a seasoned team of staffing specialists. We are committed to providing both technical support and industry expertise to simplify the hiring process. We know that your time matters. W3Global will help you streamline the hiring process, getting it done and getting it right.