Director, Engineering - Insulin
The Director Engineering will lead the Petersburg Insulin program at Civica and is a member of the site leadership team at Petersburg.
Responsibilities of the position include leading, directing and coordinating the Petersburg Insulin program including the newly announced facility expansion that includes a dedicated high-speed cartridge filling line, significant utilities upgrade, dedicated formulation and processing suites, with Clean In Place (CIP) and Sanitize In Place (SIP) capabilities.
This includes assisting in development of strategic vision and long-range planning for the site, as well as a focus on execution and team building to ensure compliance with Civica cultural tenets and sustainable and cost-effective manufacturing operations for the site.
Champions a safe working environment and compliance to established policies, procedures, and guidelines for the engineering department and the overall site.
Essential Duties and ResponsibilitiesThe essential functions include, but are not limited to the following:
Lead the Petersburg Insulin program team and drive accountability for deliverables in a matrix environment.
Provide engineering and technical leadership and management to ensure that the mission, core values and culture of the Company are put into practice at the site.
Lead site Insulin program team and provide oversight of detailed facility and equipment design, construction, process development/validation, and qualification.
Implement site engineering/maintenance/technical services strategy in alignment with site, company plans and member needs.
Establish performance and development plans for department staff, as standardized by the site and company, consistent with a culture of individual and team accountability and high performance.
Establish project performance goals, milestones, and objectives.
Interact with other functional disciplines throughout the site and company, as necessary, in achieving both site and company objectives.
Minimum Qualifications (Knowledge, Skills, and Abilities) Must have a college degree in a relevant discipline, such as engineering and/or the sciences, and at least 15 years of experience in large, complex capital projects and engineering management in a pharmaceutical manufacturing environment.
Must have 10
years of biologics biopharma experience with aseptic product manufacturing and/or injectable drugs.
Exceptional leadership abilities to inspire and motivate others to perform well, and accept feedback from others; delegate work assignments, give authority to work independently, set expectations, and monitor delegated activities.
o Ability to involve staff in planning, decision-making, facilitating, and process improvement; be available to staff; provide regular performance feedback; and develop subordinates' skills and encourage growth.
o Experience with leading cross-functional teams in a matrix environment.
Comprehensive knowledge of industry and industry-related trends and forecasts, including direct and comprehensive familiarity with FDA compliance requirements, such as cGMPs, cGLPs, cGDPs, DSCSA, etc.
o Ability to identify and resolve problems in a timely manner, as well as skillfully gather and analyze information utilizing appropriate root cause analysis, FMEA, and other tools.
o Demonstrate effective project management skills, including use of appropriate tools and ongoing oversight.
o Speak clearly and persuasively in positive or negative situations, demonstrate group presentation skills, and conduct productive meetings (documented action plans, identified responsibilities, and timing).
o Willingness to explore ways to improve and promote quality and regulatory compliance; demonstrate accuracy and thoroughness; and maintain compliance with legal and regulatory requirements.
o Develop, implement, promote, and enforce site environmental, health, safety and security procedures for all personnel, equipment, materials, and activities at the site.
Thorough understanding and experience in developing and implementing state-of-the-art technical strategies through knowledge of industry practices, company history, culture, identity, and goals.
PI0a419caf7174-31181-33260088 Recommended Skills Business Process Improvement Construction Decision Making Failure Mode Effects Analysis Forecasting Leadership Estimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities of the position include leading, directing and coordinating the Petersburg Insulin program including the newly announced facility expansion that includes a dedicated high-speed cartridge filling line, significant utilities upgrade, dedicated formulation and processing suites, with Clean In Place (CIP) and Sanitize In Place (SIP) capabilities.
This includes assisting in development of strategic vision and long-range planning for the site, as well as a focus on execution and team building to ensure compliance with Civica cultural tenets and sustainable and cost-effective manufacturing operations for the site.
Champions a safe working environment and compliance to established policies, procedures, and guidelines for the engineering department and the overall site.
Essential Duties and ResponsibilitiesThe essential functions include, but are not limited to the following:
Lead the Petersburg Insulin program team and drive accountability for deliverables in a matrix environment.
Provide engineering and technical leadership and management to ensure that the mission, core values and culture of the Company are put into practice at the site.
Lead site Insulin program team and provide oversight of detailed facility and equipment design, construction, process development/validation, and qualification.
Implement site engineering/maintenance/technical services strategy in alignment with site, company plans and member needs.
Establish performance and development plans for department staff, as standardized by the site and company, consistent with a culture of individual and team accountability and high performance.
Establish project performance goals, milestones, and objectives.
Interact with other functional disciplines throughout the site and company, as necessary, in achieving both site and company objectives.
Minimum Qualifications (Knowledge, Skills, and Abilities) Must have a college degree in a relevant discipline, such as engineering and/or the sciences, and at least 15 years of experience in large, complex capital projects and engineering management in a pharmaceutical manufacturing environment.
Must have 10
years of biologics biopharma experience with aseptic product manufacturing and/or injectable drugs.
Exceptional leadership abilities to inspire and motivate others to perform well, and accept feedback from others; delegate work assignments, give authority to work independently, set expectations, and monitor delegated activities.
o Ability to involve staff in planning, decision-making, facilitating, and process improvement; be available to staff; provide regular performance feedback; and develop subordinates' skills and encourage growth.
o Experience with leading cross-functional teams in a matrix environment.
Comprehensive knowledge of industry and industry-related trends and forecasts, including direct and comprehensive familiarity with FDA compliance requirements, such as cGMPs, cGLPs, cGDPs, DSCSA, etc.
o Ability to identify and resolve problems in a timely manner, as well as skillfully gather and analyze information utilizing appropriate root cause analysis, FMEA, and other tools.
o Demonstrate effective project management skills, including use of appropriate tools and ongoing oversight.
o Speak clearly and persuasively in positive or negative situations, demonstrate group presentation skills, and conduct productive meetings (documented action plans, identified responsibilities, and timing).
o Willingness to explore ways to improve and promote quality and regulatory compliance; demonstrate accuracy and thoroughness; and maintain compliance with legal and regulatory requirements.
o Develop, implement, promote, and enforce site environmental, health, safety and security procedures for all personnel, equipment, materials, and activities at the site.
Thorough understanding and experience in developing and implementing state-of-the-art technical strategies through knowledge of industry practices, company history, culture, identity, and goals.
PI0a419caf7174-31181-33260088 Recommended Skills Business Process Improvement Construction Decision Making Failure Mode Effects Analysis Forecasting Leadership Estimated Salary: $20 to $28 per hour based on qualifications.
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