We are seeking a highly skilled and experienced Commissioning and Qualification Subject Matter Expert (SME) to join our team at a greenfield small molecule manufacturing site. As the Commissioning and Qualification SME, you will play a pivotal role in ensuring the successful startup, commissioning, qualification, and validation of the site's process equipment and systems. Your extensive expertise in DeltaV and process equipment, coupled with a minimum of 10 years of experience in the pharmaceutical or chemical manufacturing industry, will be instrumental in achieving operational excellence and regulatory compliance.

Key Responsibilities:

Commissioning and Qualification Leadership: Lead and oversee all aspects of commissioning and qualification activities for the greenfield small molecule manufacturing site, ensuring adherence to industry best practices, regulatory requirements, and project timelines.
DeltaV System Integration: Utilize your profound knowledge of DeltaV distributed control systems (DCS) to configure, test, and troubleshoot process control systems and ensure seamless integration with various equipment and processes.
Process Equipment Expertise: Apply your extensive experience with a wide range of process equipment, including but not limited to reactors, distillation units, filtration systems, and utilities, to support successful commissioning and qualification efforts.
Validation Planning and Execution: Develop comprehensive validation strategies and protocols for equipment, systems, and processes, and execute validation activities in compliance with regulatory guidelines (e.g., cGMP, FDA).
Risk Assessment: Conduct risk assessments to identify potential issues or deviations during commissioning and qualification phases and implement effective mitigation strategies.
Documentation and Reporting: Maintain detailed records of commissioning and qualification activities, generate reports, and provide documentation to regulatory authorities as required.
Cross-Functional Collaboration: Collaborate closely with project teams, engineering, quality, and regulatory affairs teams to ensure alignment of commissioning and qualification activities with project goals and regulatory standards.
Training and Knowledge Transfer: Provide training and mentorship to junior staff members and ensure knowledge transfer within the organization to enhance team capabilities.
Continuous Improvement: Identify opportunities for process optimization and efficiency improvements during commissioning and qualification activities.

Qualifications:

Bachelor's or Master's degree in Chemical Engineering, Mechanical Engineering, or a related field.
Minimum of 10 years of relevant experience in commissioning, qualification, and validation within the pharmaceutical or chemical manufacturing industry.
Proficiency in DeltaV distributed control systems and associated software.
In-depth knowledge of regulatory requirements, including cGMP, FDA, and ICH guidelines.
Strong problem-solving skills and the ability to troubleshoot complex process equipment and systems.
Excellent communication and interpersonal skills to effectively collaborate with cross-functional teams.
Proven leadership abilities and the capability to manage and mentor a team.
Attention to detail and a commitment to ensuring product quality and safety.
Project management experience is a plus.

What We Offer:

PTO – 18 days (Company Policy).
Federal – 6 days
Employee Healthcare – we have four options; one of them we cover 100% for the employee.
Identity Theft Insurance – Employee policy 100% covered by HCG.
401K – with a company match of up to 3.5%.
HCG also offers 401K Profit Sharing.
HCG Technical - Company laptop provided if needed.

Horizon Controls Group

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Commissioning and Qualification SME