Job Title: CQV Project Manager - Automation
Job Overview:
Horizon Controls Group are seeking an experienced CQV (Commissioning, Qualification, and Validation) Project Manager with expertise in automation to join our team in a heavily automated bio pharmaceutical setting. The successful candidate will be responsible for managing CQV projects for new automation systems and equipment, ensuring compliance with regulatory requirements and industry standards.
Key Responsibilities:

• 
  Develop and manage CQV project plans and schedules for new automation systems and equipment, including design, installation, commissioning, qualification, and validation.
• Collaborate with cross-functional teams, including engineering, automation, manufacturing, quality, and regulatory affairs, to ensure compliance, safety, and performance of automation systems and equipment.
• Develop and execute validation protocols, including IQ, OQ, and PQ, and ensure timely completion of validation activities.
• Lead risk assessments and develop risk mitigation plans for new automation systems and equipment.
• Manage change control processes for automation systems and equipment, including assessing the impact of changes on the overall system.
• Develop and maintain documentation related to CQV, including validation plans, protocols, reports, and SOPs.
• Provide technical support to manufacturing, quality, and automation teams during troubleshooting and problem-solving activities.

Requirements:

• 
  Bachelors degree in Engineering, Science, or related field.
• 7+ years of experience in CQV project management, preferably in a heavily automated bio pharmaceutical setting.
• Strong knowledge of regulatory requirements and industry standards related to CQV, including cGMP, ISO, and FDA regulations.
• Experience with automation systems and equipment, including PLCs, HMIs, and SCADA systems.
• Experience with commissioning, qualification, and validation of automation systems and equipment.
• Excellent communication, project management, and leadership skills.
• Ability to work collaboratively with cross-functional teams.

Preferred Skills:

• Experience with risk management processes and tools, including FMEA and HAZOP.
• Knowledge of pharmaceutical development and manufacturing processes.
• Experience with data integrity and cybersecurity requirements for automation systems and equipment.

Benefits:


PTO \xe2\x80\x93 18 days (Company Policy)
Federal \xe2\x80\x93 6 days
Employee Healthcare \xe2\x80\x93 we have four options; one of them we cover 100% for the employee
Life Insurance - Employee policy 100% covered by HCG
Long Term Disability Insurance - Employee policy 100% covered by HCG
Identity Theft Insurance - Employee policy 100% covered by HCG
401K - with a company match of up to 3.5%
HCG also offer 401K Profit Sharing
HCG Technical - Company Laptop provided if needed
HCG brand items \xe2\x80\x93 Clothing, Stationery, Quarterly care packs etc.


We support our diversity, equity, inclusion and belonging efforts because we believe that by cultivating an environment where our diverse employees can share their ideas and thrive, we will be able to better serve our organization and our global customers. Our commitment is that we have an inclusive culture that values each of our employees background, by empowering our staff to feel valued, have a sense of belonging, make positive contributions to the communities in which they live and work, and be proud to be part of Horizon Controls Group.