The Validation Associate III at Wacker Biotech will play a critical role in supporting the development, optimization, and execution of validation & engineering processes for the production of plasmid DNA (pDNA) and other biopharmaceutical products. This position requires a highly skilled and experienced professional who is familiar with a variety of validation & engineering concepts, practices, and procedures. The ideal candidate will rely on their expertise and judgment to plan and accomplish goals, while providing technical leadership, driving continuous improvement initiatives, and supporting Building Management Systems (BMS), automation systems and validation activities to ensure operational excellence.

Essential Functions:

• Subject Matter Expert (SME) for Building Management System (BMS) and Automation Support to ensure proper monitoring and control of critical facility systems, including HVAC, utilities, and environmental conditions.
• Troubleshoot and resolve issues related to BMS and automation systems to minimize downtime and ensure operational stability.
• Collaborate with vendors and contractors to implement upgrades or modifications to BMS and automation systems.
• Process Improvement and Problem Solving, identify opportunities for process optimization and implement innovative solutions to improve manufacturing performance.
• Plan, execute, and oversee validation & engineering projects, ensuring they are completed on time, within scope, and on budget. Manage the process of required documentation, including project plans, validation protocols, and technical reports.
• Troubleshoot and resolve complex equipment and process issues to minimize downtime and ensure operational stability.
• Collaborate with vendors and contractors to ensure equipment and systems meet performance and compliance requirements.
• Stay up to date with industry trends and emerging technologies to drive innovation in biopharmaceutical manufacturing.
• Evaluate and implement new technologies to enhance production capabilities and efficiency.
• Work closely with cross-functional teams to ensure alignment on project goals and deliverables.
• Communicate project updates, risks, and outcomes to stakeholders and leadership.
• Foster a collaborative and innovative work environment that supports team success.

Position Qualifications:

• Bachelor’s degree in validation or engineering (Chemical, Mechanical, or related field)
• 5-8 years of experience in a FDA and GMP regulated industry.
• ISO 7 & ISO 8 gowning experience is preferred.
• Familiarity with a variety of relevant validation & engineering concepts, practices, and procedures.
• Strong problem-solving and analytical skills, with the ability to develop creative solutions.
• Proven ability to manage multiple complex projects simultaneously.
• Experience with Building Management Systems (BMS) and automation technologies.
• Excellent written and verbal communication skills, with experience in technical writing and documentation.
• Proficiency in validation & engineering software and tools, as well as Microsoft Office Suite.
• Knowledge of regulatory requirements, including FDA, GMP, and ISO standards.
• Requires good written, verbal, and interpersonal communication skills and the ability to effectively interact with all levels.
• Ability to handle multiple assignments and changing priorities.
• Positive, proactive approach to drive assignments/tasks to completion.
• Proficiency with Microsoft Word, Excel, PowerPoint
• Ability or capable of lifting up to fifty (50) lbs.

The anticipated salary range for candidates who will work in California is $76,500-$101,500. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Wacker is a multi-state employer, and this salary range may not reflect positions that work in other states.

• Compensation and Incentive plans
• Medical, Dental, and Vision Insurance effective day 1
• Paid Time Off in addition to personal days and holidays
• Paid parental leave
• Wellbeing fund
• Flexible hybrid work arrangements
• 401(k) with company match
• Education Assistance Program
• Career development and advancement opportunities
• Support for Community Involvement