• Lead and manage projects from initiation to closure, including requirements gathering, design, development, testing, deployment, and maintenance phases.
• Collaborate with cross-functional teams, including designers, developers, architects, and stakeholders, to define project scope, objectives, and deliverables.
• Apply your technical expertise to provide guidance and insights during project design, implementation, and problem-solving activities.
• Lead validation activities across the full project lifecycle, including requirements gathering, planning, execution, and documentation.
• Assist in providing construction support and the A&E construction design process.
• Create detailed design specifications, drawings, and prototypes using industry-standard tools. Conduct testing and analysis to ensure designs meet performance, reliability, and safety criteria.
• Execute project lifecycle documentation, design documentation (URS, FS, DS), and construction control plans.
• Lead change control processes, evaluating proposed changes for their impact on validated processes, equipment, and systems. Maintain accurate and organized validation and change control documentation, including protocols, reports, risk assessments, and change control records.
• Develop and execute commissioning, qualification, and validation strategies, protocols, and plans for equipment, facilities, utilities, and processes.
• Develop comprehensive validation plans, protocols, SOPs, and reports that adhere to regulatory requirements and company guidelines.
• Generate and execute decommissioning/commissioning protocols.
• Analyze validation results, identify deviations or issues, and work collaboratively to develop and implement corrective and preventive actions.
• Participate in regulatory audits and inspections, ensuring that all validation processes, change control practices, and documentation meet regulatory requirements.
• Effectively collaborate with cross functional project teams to drive project completion and deliverables. 
• Additional duties may be assigned. 

Requirements

• Bachelor's Degree in engineering.
• 7 years of design, validation, commissioning, qualification experience within cGMP/Biotech/Pharmaceutical Manufacturing/FDA regulated industries.
• Expertise in developing and executing validation protocols. 
• Experienced with the validation of pharmaceutical utilities (RO, Compressed Air, Ambient WFI, air handlers, CIP systems, boilers, etc.), automation (Delta V, BAS, etc.), and cleaning and process validation.
• Strong knowledge of DeltaV, HVAC control, Siemens BAS, MES, and EBM. 
• Knowledge of ISPE Baseline Guide Chapter 5 for C&Q.
• Knowledge of ASTM E2500.
• Excellent knowledge of cGMP/FDA regulations/ ICH guidelines and other international regulatory requirements.
• Experience supporting multiple downstream biotech processes and equipment including protocol (IQ/OQ/PQ) generation and execution.
• Ability to support and drive project success through extreme deadlines. 
• Ability to adapt to changing priorities, manage ambiguity, and drive results in a fast-paced environment.
• Strong leadership capabilities. 
• Excellent technical writing, review, and analytical skills.
• Ability to organize and manage multiple tasks in a fast-paced environment.
• Excellent communication and interpersonal abilities to effectively collaborate with stakeholders at all levels.
• Proficient in Microsoft Office including Word, Excel, PowerPoint, MS Project, Visio, etc.
• This position is on-site, full-time with the ability to work extended hours when needed during shut down. 
• At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.

Benefits

• Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
• Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
• 401(k) and 401(k) matching
• PTO, Sick Time, and Paid Holidays
• Education Assistance
• Pet Insurance
• Discounted rate at Anytime Fitness
• Financial Perks and Discounts