Vitalent
Director, Production Maintenance
Vitalent, Bloomsbury, New Jersey, us, 08804
ViTalent is a premier professional services organization that specializes in talent acquisition, talent development, staffing, and consulting for the Life Sciences industry. Our business is people! Talent is in high demand and our simple mission is to impact lives as a long-term partner for both talent and organizations.
We are currently seeking a
Director, Production Maintenance
with experience in the Life Sciences industry for QuVa Pharma, a leader in quality-compliant manufacturing of compounded, ready-to-administer sterile injectable products with unmatched 503B experience. The Director, Production Maintenance will be responsible for supporting and maintaining production equipment at the manufacturing facilities as well as manage and oversee the CMMS (Computerized Maintenance Management System).
The incumbent must be able to lead and direct a team of qualified individuals, leveraging core competencies to ensure uptime of production equipment and production lines, identify and implement improvements and increase equipment reliability. This role is also responsible for identifying and overseeing the execution of critical equipment reliability initiatives across the network. Additionally, it includes oversight of production equipment capital budgeting and monitoring with a focus on continuous improvement activities to driving equipment reliability and line availability.
Responsibilities may include: •Provides hands-on leadership, oversight, and execution of Production Maintenance team for the whole network. •Provide technical input to Engineering team for the design of process automation equipment identified for prep, filling and ILP operations. •Establishes policies and procedures for equipment related matters with management reporting through the development metrics and performance indicators to monitor and trend result, and taking actions to correct, prevent and/or improve execution and future performance. •Participates in development of strategic planning associated with development of site infrastructure to ensure capacity, capability, and compliance (C3) are deeply embedded within processes, systems and controls implemented to support day to day manufacturing operations. •Establishes and communicates a clear vision for a fully integrated and high performing team that is aligned with the strategic objectives and business goals. •Proposes and assists with development of capital project budgets to inform and protect business objectives. •Supports site management through the identification and introduction of equipment upgrades and innovative solutions that drive continuous improvement. •Defines and implements necessary equipment improvements within the existing operation to maintain current cGMP and Industry Best practices; as well as drive industry standards with regards to 503B outsourcing manufacturing facilities through participation and engagement with regulators, industry subject-matter experts on equipment design, knowledge and principles from other related industry segments that utilize controlled environments and aseptic manufacturing. •Responsible for developing and implementing skills and techniques needed to maintain, troubleshoot, and provide suggestions for improvement to automated, and semi-automated PLC controlled equipment. •Networks and partners effectively internally with cross-functional disciplines (Procurement, Technical Operations, Manufacturing, Quality, Finance, IT, HR) as well as externally with customers, suppliers, and regulators to ensure compliance with company policies, procedures, and regulatory requirements, as well as promote an organizational culture that supports the achievement of business objectives. •Support and lead the CMMS administration. •Responsible for the development of enhancements and process improvement regarding the Computerized Maintenance management System. •Responsible for the development and oversight of Preventative Maintenance (PM) program •Other duties as assigned.
Qualifications: •Authorized to work for any employer in the United States without visa sponsorship. •Over 10+ years of experience in manufacturing and production within the pharmaceutical industry, including more than 5+ years in supervisory roles. Bachelor of Science in related field required. •Pharmaceutical equipment operation, design and maintenance experience preferred.
Candidates must be a U.S. citizen or national, or an alien admitted as permanent resident, refugee, asylee or temporary resident under 8 U.S.C. 1160(a) or 1255(a)(1). Individuals with temporary visas such as E, F-1, H-1, H-2, L, B, J, or TN or who need sponsorship for work authorization now or in the future, are not eligible for hire.
All applicants will be considered for employment regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.
#VTLS
#LI-LN1
We are currently seeking a
Director, Production Maintenance
with experience in the Life Sciences industry for QuVa Pharma, a leader in quality-compliant manufacturing of compounded, ready-to-administer sterile injectable products with unmatched 503B experience. The Director, Production Maintenance will be responsible for supporting and maintaining production equipment at the manufacturing facilities as well as manage and oversee the CMMS (Computerized Maintenance Management System).
The incumbent must be able to lead and direct a team of qualified individuals, leveraging core competencies to ensure uptime of production equipment and production lines, identify and implement improvements and increase equipment reliability. This role is also responsible for identifying and overseeing the execution of critical equipment reliability initiatives across the network. Additionally, it includes oversight of production equipment capital budgeting and monitoring with a focus on continuous improvement activities to driving equipment reliability and line availability.
Responsibilities may include: •Provides hands-on leadership, oversight, and execution of Production Maintenance team for the whole network. •Provide technical input to Engineering team for the design of process automation equipment identified for prep, filling and ILP operations. •Establishes policies and procedures for equipment related matters with management reporting through the development metrics and performance indicators to monitor and trend result, and taking actions to correct, prevent and/or improve execution and future performance. •Participates in development of strategic planning associated with development of site infrastructure to ensure capacity, capability, and compliance (C3) are deeply embedded within processes, systems and controls implemented to support day to day manufacturing operations. •Establishes and communicates a clear vision for a fully integrated and high performing team that is aligned with the strategic objectives and business goals. •Proposes and assists with development of capital project budgets to inform and protect business objectives. •Supports site management through the identification and introduction of equipment upgrades and innovative solutions that drive continuous improvement. •Defines and implements necessary equipment improvements within the existing operation to maintain current cGMP and Industry Best practices; as well as drive industry standards with regards to 503B outsourcing manufacturing facilities through participation and engagement with regulators, industry subject-matter experts on equipment design, knowledge and principles from other related industry segments that utilize controlled environments and aseptic manufacturing. •Responsible for developing and implementing skills and techniques needed to maintain, troubleshoot, and provide suggestions for improvement to automated, and semi-automated PLC controlled equipment. •Networks and partners effectively internally with cross-functional disciplines (Procurement, Technical Operations, Manufacturing, Quality, Finance, IT, HR) as well as externally with customers, suppliers, and regulators to ensure compliance with company policies, procedures, and regulatory requirements, as well as promote an organizational culture that supports the achievement of business objectives. •Support and lead the CMMS administration. •Responsible for the development of enhancements and process improvement regarding the Computerized Maintenance management System. •Responsible for the development and oversight of Preventative Maintenance (PM) program •Other duties as assigned.
Qualifications: •Authorized to work for any employer in the United States without visa sponsorship. •Over 10+ years of experience in manufacturing and production within the pharmaceutical industry, including more than 5+ years in supervisory roles. Bachelor of Science in related field required. •Pharmaceutical equipment operation, design and maintenance experience preferred.
Candidates must be a U.S. citizen or national, or an alien admitted as permanent resident, refugee, asylee or temporary resident under 8 U.S.C. 1160(a) or 1255(a)(1). Individuals with temporary visas such as E, F-1, H-1, H-2, L, B, J, or TN or who need sponsorship for work authorization now or in the future, are not eligible for hire.
All applicants will be considered for employment regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.
#VTLS
#LI-LN1