• Develop comprehensive project plans, including scope, schedule, and budget, and ensure adherence to project timelines.
• Coordinate with cross-functional teams to ensure project objectives are met. Monitor project progress, making adjustments as necessary.
• Facilitate effective communication within the project team and with external stakeholders.
• Provide construction supervision and proactively support in construction administration activities. Address any construction-related issues and provide timely resolutions.
• Assist in writing construction control plans. 
• Develop and execute commissioning, qualification, and validation protocols and strategies for required equipment, including but not limited to HVAC systems, WFI systems, AHU systems, and so on. 
• Collaborate with relevant stakeholders to optimize system performance and compliance.
• Review, draft, and author required CQV documentation and reports, ensuring regulatory compliance and industry standards are met.
• Draft engineering specification documentation including but not limited to functional specifications and design specifications.
• Verify design drawings as required, and provide technical design expertise as needed. 
• Effectively conduct risk analysis, develop mitigation strategies, and implement corrective and preventative action. 
• ​Conduct regular reviews to assess project performance and identify areas for improvement. Implement change control processes to minimize project risks.
• Additional responsibilities as required. 

Requirements

• Bachelor's Degree in related engineering discipline. 
• 5-7 years of commissioning, qualification, and validation experience in the pharmaceutical manufacturing industry.
• Project coordination and project management experience is required.
• Experience with HVAC system and WFI system qualification is required.
• Ability to provide effective team leadership and drive project success. 
• Excellent technical writing skills. Experienced writing CQV protocols, reports, engineering specifications, and SOPs. 
• Experience in verifying design drawings and specifications.
• Previous experience working with construction projects and/or construction administration is highly preferred. 
• Strong data analysis skills and problem solving capabilities.
• Excellent communication and interpersonal skills, with the ability to lead and collaborate across teams. 
• 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