Manager Manufacturing Single Use Systems Holly Springs, NC
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Job Location:
Holly Springs, MS - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.
What you will do
Lets do this. Lets change the this vital role you will act as the Manager for the Single Use Systems and Cleaning Validation Team in our GMP Drug Substance Manufacturing facility. This position is within Amgen North Carolina (ANC) Drug Substance FlexBatch Manufacturing facility in the- Manufacturing Support organization.
ANC is a dynamic environment and an important supply facility for Amgens pipeline products. The GMP FlexBatch plant manufactures drug substance for clinical trials and commercial supply through GMP production using both stainless steel and single-use equipment this vital role you will act as the Manager for Single Use Systems and Cleaning Validation leading a team responsible for the oversight implementation and continuous improvement of single use technologies and equipment cleaning validation strategies in GMP manufacturing. You will be a key technical and communication interface between manufacturing operations process development engineering supply chain and quality.
Provide technical leadership and subject matter expertise for Single Use Systems and equipment cleaning validation activities in the manufacturing area.
Oversee development implementation and maintenance of SOPs training materials and Quality Management System records related to Single Use Systems and equipment cleaning validation.
Lead development and execution of the sites Cleaning Validation Master Plan (CIP/SIP/COP for equipment and controlled temperature chambers) validation plans equipment qualification protocols/reports and cleaning validation strategies.
Manage and mentor a team of specialists and engineers including hiring training performance evaluations and development.
Coordinate troubleshooting and support during commissioning qualification start-up and process performance qualification of the facility.
Facilitate process area and equipment risk assessments to identify risks failure modes and mitigating actions.
Ensure compliance with regulatory requirements support regulatory submissions audits and inspections.
Champion Lean Transformation and operational excellence initiatives driving continuous improvement in the plant.
Collaborate cross-functionally with Manufacturing Engineering Quality Supply Chain and Process Development to ensure alignment and readiness for new products process changes and advanced technologies.
Develop and implement training plans and programs to ensure staff are prepared and compliant.
Maintain inspection readiness and support staff with audit or regulatory response strategy.
What you will do
Lets do this. Lets change the this vital role you will act as the Manager for the Single Use Systems and Cleaning Validation Team in our GMP Drug Substance Manufacturing facility. This position is within Amgen North Carolina (ANC) Drug Substance FlexBatch Manufacturing facility in the- Manufacturing Support organization.
ANC is a dynamic environment and an important supply facility for Amgens pipeline products. The GMP FlexBatch plant manufactures drug substance for clinical trials and commercial supply through GMP production using both stainless steel and single-use equipment this vital role you will act as the Manager for Single Use Systems and Cleaning Validation leading a team responsible for the oversight implementation and continuous improvement of single use technologies and equipment cleaning validation strategies in GMP manufacturing. You will be a key technical and communication interface between manufacturing operations process development engineering supply chain and quality.
Provide technical leadership and subject matter expertise for Single Use Systems and equipment cleaning validation activities in the manufacturing area.
Oversee development implementation and maintenance of SOPs training materials and Quality Management System records related to Single Use Systems and equipment cleaning validation.
Lead development and execution of the sites Cleaning Validation Master Plan (CIP/SIP/COP for equipment and controlled temperature chambers) validation plans equipment qualification protocols/reports and cleaning validation strategies.
Manage and mentor a team of specialists and engineers including hiring training performance evaluations and development.
Coordinate troubleshooting and support during commissioning qualification start-up and process performance qualification of the facility.
Facilitate process area and equipment risk assessments to identify risks failure modes and mitigating actions.
Ensure compliance with regulatory requirements support regulatory submissions audits and inspections.
Champion Lean Transformation and operational excellence initiatives driving continuous improvement in the plant.
Collaborate cross-functionally with Manufacturing Engineering Quality Supply Chain and Process Development to ensure alignment and readiness for new products process changes and advanced technologies.
Develop and implement training plans and programs to ensure staff are prepared and compliant.
Maintain inspection readiness and support staff with audit or regulatory response strategy.
Additional Qualifications/Responsibilities
What we expect of you
We are all different yet we all use our unique contributions to serve patients. The professional we seek will possess these qualifications.
Basic Qualifications:
High school diploma/GED and 12 years of biotechnology operations or validation experience OR
Associates degree and 10 years of biotechnology operations or validation experience OR
Bachelors degree and 5 years of biotechnology operations or validation experience OR
Masters degree and 3 years of biotechnology operations or validation experience OR
Doctorate degree
Preferred Qualifications:
Educational background in Chemical Engineering Industrial Engineering Biology Biochemistry Life Sciences or related field.
Experience leading/managing a team of direct reports in a GMP manufacturing environment.
Strong technical knowledge of Single Use Systems and Cleaning Validation strategies for biologics manufacturing.
Experience in supporting regulatory submissions audits and inspections.
Proficient technical writing and presentation skills to communicate complex information effectively with technical and senior management staff.
Experience in cross-functional project management and operational excellence initiatives.
Ability to coach mentor and cross-train colleagues within core technical areas.
Background in lean manufacturing methodologies and continuous improvement.
Knowledge of relevant regulations (e.g. FDA Title 21 CFR Part 210/211 Eudralex Annex 15 ASTM E2500 ICH Q7).
Required Experience:
Manager
Key Skills
- Lean Manufacturing
- Six Sigma
- Continuous Improvement
- ISO 9001
- Lean Six Sigma
- Management Experience
- Manufacturing & Controls
- 5S
- Manufacturing Management
- Kaizen
- Chemistry
- Manufacturing
About Company
VetJobs & Military Spouse Jobs works with our employer partners to source, screen, and move qualified talent to the desktops of the Hiring Managers. Application is a two-step process, so please be patient with the team. When you submit to a position on our site your information will ... View more
