<p>Senior Quality Engineer Division Belmar Pharma Solutions Category Quality Control Description</p> <p>POSITION OVERVIEW</p> <p>The Senior Quality Engineer independently executes individual projects and leads cross-functional teams to implement larger projects. This role provides guidance and technical decision-making to the Quality Engineering personnel regarding cGMP compliance, regulatory issues, investigation strategies, process improvement initiatives, and quality systems for projects and/or strategic activities. This role supports the Quality Engineering Supervisor's direction for the organization.</p> <p>RESPONSIBILITIES</p> <ul> <li> <p>Authoring, reviewing, and approving deviations, investigations, and CAPAs. Acting as Subject Matter Expert on Root Cause Analysis tools. Providing guidance on setting realistic timelines for these deviation management system documents, as well as organized updates and effectiveness check strategies.</p> </li><li> <p>Identifying, owning, and implementing process improvements. Ensuring timely completion of deliverables, regular status communication, proper training to hand over to process owners, and team recognition for successful completion.</p> </li><li> <p>Preparing, reviewing, and approving Change Controls. Coordinate company-wide to ensure change is well challenged, effectively implemented, and thoroughly closed.</p> </li><li> <p>Reviewing and approving validation and qualification activities (protocols, final reports) to support company, equipment, product and/or performance processes.</p> </li><li> <p>Executing, providing guidance, and overseeing department-wide Quality Systems, metrics and reporting, for example Customer Complaint Response & Evaluation, Quality Metric and KPI administration & presentation, and similar.</p> </li><li> <p>Supporting job interviews, motivation, coaching, and training in coordination with the Quality Engineering Leader.</p> </li><li> <p>Providing a professional, dynamic, cooperative, and high-achieving work environment for the staff.</p> </li><li> <p>Supporting Quality Engineering Leadership by coaching other QEs in skills related to technical skills, management and leadership.</p> </li><li> <p>Supporting day-to-day activities Quality response to production issues, for example, assessing Visual Inspection defects, supporting complex GDP corrections, evaluating raised issues to determine if a deviation is required, etc.</p> </li></ul> <p>SUPERVISE DIRECT REPORTS (yes or no)</p> <p>PHYSICAL REQUIREMENTS</p> <ul> <li> <p>Position requires use of necessary equipment such as computers, scanners, or other technology devices as assigned.</p> </li><li> <p>Must be able to work in a variety of positions and locations such as sitting, standing, squatting, kneeling, reaching, and walking, for prolonged periods of time.</p> </li><li> <p>Position requires handling of laboratory chemicals or hazardous materials.</p> </li><li> <p>Position requires infrequent gowning into ISO classified spaces. This requires removal of makeup, jewelry (rings piercings, etc), and items that shed. This also may require wearing PPE for long periods of time.</p> </li><li> <p>Position requires infrequent lifting of up to 50 lbs.</p> </li></ul> <p>QUALIFICATIONS/</p> <p>TRAINING</p> <p>(e.g. professional qualifications, on-the-job training, education)</p> <p>Qualifications and Education Requirements?</p> <ul> <li> <p>REQUIRED: Bachelor's degree in engineering (Chemical, Mechanical, Manufacturing, Electrical, or Software). Other STEM degrees shall considered with applicable work experience.</p> </li><li> <p>REQUIRED: Experience in a Pharmaceutical cGMP environment, including a sufficient understanding of industry expectations to independently provide sound Quality input and decisions.</p> </li><li> <p>Experience supporting manufacturing operations through implementing improvements to support production processes.</p> </li><li> <p>Thorough understanding of applicable Root Cause Analysis tools, metrics analysis, and scientific practices.</p> </li><li> <p>Proficient in Microsoft Office Applications.</p> </li><li> <p>Excellent communication skills, both oral and written. Ability to work as part of a team and/or independently and provide leadership. Emphasis in technical writing ability, however communication may include a variety of audiences (technicians, technical support staff, management, customers, etc.)</p> </li><li> <p>Ability to resolve conflicts and provide solutions.</p> </li><li> <p>Must be able to read, understand and follow cGMPs, SOPs, Specifications, and industry guidelines as they relate to the process.</p> </li><li> <p>Time management skills and the ability to manage oneself. Projects must be completed in a timely manner despite aggressive timelines.</p> </li><li> <p>Superior attention to detail.</p> </li></ul> <p>Preferred Skills</p> <ul> <li> <p>3-5 years of experience and/or knowledge of pharmaceutical processes, systems, equipment, and applicable government regulations.</p> </li><li> <p>Experience managing Quality Systems, especially Deviation, Investigation, CAPA.</p> </li><li> <p>Familiarity with industry guidance and regulation documents, for example FDA Guidance for the Industry, 21 CFR 211, USP, ISO Manufacturing.</p> </li><li> <p>Experience with Smartsheet, PowerBI, SharePoint, ACE or other Document Management Software, Adobe Acrobat.</p> </li><li> <p>Experience with Validation (Process Validation, Equipment IQ/OQ/PQ).</p> </li></ul> <p>Travel</p> <p>As part of your job duties, travel may be required. If applicable, you will be compensated at the current IRS mileage reimbursement rate.</p> <p>Pay Range: $84,000 - $91,000</p> <p>Position Requirements Full-Time/Part-Time Full-Time Shift Days User5 Position Pay Range $84,000 - $91,000 City and State Position Senior Quality Engineer Exempt/Non-Exempt Exempt Open Date 3/6/2026 Location BSOGO EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.</p>