FFL Biopharmaceutical Production Operations Supervisor
4.
1 Marietta, PA Marietta, PA Full-time Full-time $88,000 - $103,000 a year $88,000 - $103,000 a year 1 day ago 1 day ago 1 day ago Are you looking for an opportunity to lead the production planning delivery within the safety, quality, planning, and budget in a complex and highly regulated environment? If so, this is the opportunity! The Biopharmaceutical FFL Operations Supervisor role is for you.
As Biopharmaceutical FFL Production Operations Supervisor you will supervise the FFL Operations production team to meet required quality, compliance, and delivery targets of process validation lots and commercial products.
Ensure operations are executed in cGMP compliant manner and comply with company conformance standards and all applicable regulations.
Manage the training and qualifications for staff to ensure all operating procedures are followed and compliant with all company-defined standards and federal regulations.
Develop skills, supervise, lead and motivate an operations team.
This Biopharmaceutical FFL Production OperationsSupervisor role will give YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Supervise manufacturing processes, automation equipment and personnel to ensure quality operations.
Participate in audits and investigations and recommend solutions to resolve problems including RIMP activities in support of inspection readiness for the FFL Value Stream.
Proactively and continuously manage product risk and escalate risks through site management.
Supervise the day-to-day activities of Operations Personnel on responsible shift.
Coordinate resources required to complete routine work and assigned special projects in a timely manner.
Manage manufacturing operations through SAP functions.
Assure safe and efficient operations of assigned production areas by ensuring all supervised personnel are adequately trained and perform routine inspections.
Provide functional expertise and develop technology forums to exchange best practices with site organization.
Implement safe, compliant and efficient procedures.
During active Technical Transfer projects, work with Local Team, Donor Site and Global Technology.
Lead any activities required in support of Process PQMP and PQ/PV Execution through supporting the Validation team developing PQ protocols and PQ summary reports and leading the execution of the PQ protocols.
Deployment of Process Optimization and Lean Culture within all applicable FFL Value Stream operations.
Develop and implement productivity improvement plans using Industrial Excellence methodologies.
Monitor and report progress of safety objectives, performance against schedule and number of defects.
Identify the cause of the problems and continue to educate staff on solutions, accident avoidance and error reductions.
Serve as SME in the development and maintenance of simple, effective, visual LSOPs for Equipment and Areas.
Co-owner for Quality System Events related to FFL Operations.
Support the process for and troubleshoots process deviations and equipment failures.
Promote a people focused culture in line with GSK and site culture.
Support development of others by acting as a coach and mentor.
Allocate important projects and challenging responsibilities to others for the purpose of their development.
Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, GSK standard operating & safety procedures, and industry practice and Industrial Excellence initiatives.
Why you? Biopharmaceutical FFL Production Operations Supervisor Basic
Qualifications:
We are looking for professionals with these required skills to achieve our goals:
BS or BA in a biological, chemical science, or engineering or equivalent technical discipline.
5
years prior pharmaceutical production experience and at least 3 years in a supervisory role leading cross functional teams.
Experience should include supervising and managing production in at least one of the following:
aseptic technique, filling, and lyophilization, product visual inspection, input to scheduling and planning, regulatory compliance.
Supervision to include delegating, training, communicating and prioritizing site objectives, evaluating, coaching and disciplining others.
Biopharmaceutical FFL Production Operations Supervisor Preferred
Qualifications:
If you have the following characteristics, it would be a plus:
Prior experience with project planning software.
Computer skills in Microsoft Office applications and the ability to quickly and easily learn new applications.
Knowledge of cGMPs, and the ability to quickly grasp and apply site policies and procedures and relate them to project scope.
Must possess a technical understanding of industry and scientific principles and practices related to the business.
Maintain a high level of integrity while balancing multiple priorities and responsibilities.
Excellent organizational skills and attention to detail, ability to function in an atmosphere of constant change with detailed accuracy.
Demonstrated interpersonal and leadership skills and ability to lead cross-function / international teams.
Ability to lead the process to generate the exchange of ideas to resolve problems, influence others, analyze data, prioritize solutions, select optimal solutions and implement decisions.
Sense of urgency, flexibility and accountability.
The ability to communicate effectively, both verbally and in writing, to all levels within the organization as well as the skills to communicate site operations to outside agencies.
Ability to follow written procedures and document results in a neat and precise manner.
#MariettaVaccines #vaccinessupplychain #LI-GSK Job Type:
Full-time Pay:
$88,000.
00 - $103,000.
00 per year
Benefits:
401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance Schedule:
8 hour shift Monday to Friday Ability to commute/relocate:
Marietta, PA 17547:
Reliably commute or planning to relocate before starting work (Preferred)
Experience:
Pharmaceutical Production:
5 years (Preferred) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
1 Marietta, PA Marietta, PA Full-time Full-time $88,000 - $103,000 a year $88,000 - $103,000 a year 1 day ago 1 day ago 1 day ago Are you looking for an opportunity to lead the production planning delivery within the safety, quality, planning, and budget in a complex and highly regulated environment? If so, this is the opportunity! The Biopharmaceutical FFL Operations Supervisor role is for you.
As Biopharmaceutical FFL Production Operations Supervisor you will supervise the FFL Operations production team to meet required quality, compliance, and delivery targets of process validation lots and commercial products.
Ensure operations are executed in cGMP compliant manner and comply with company conformance standards and all applicable regulations.
Manage the training and qualifications for staff to ensure all operating procedures are followed and compliant with all company-defined standards and federal regulations.
Develop skills, supervise, lead and motivate an operations team.
This Biopharmaceutical FFL Production OperationsSupervisor role will give YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Supervise manufacturing processes, automation equipment and personnel to ensure quality operations.
Participate in audits and investigations and recommend solutions to resolve problems including RIMP activities in support of inspection readiness for the FFL Value Stream.
Proactively and continuously manage product risk and escalate risks through site management.
Supervise the day-to-day activities of Operations Personnel on responsible shift.
Coordinate resources required to complete routine work and assigned special projects in a timely manner.
Manage manufacturing operations through SAP functions.
Assure safe and efficient operations of assigned production areas by ensuring all supervised personnel are adequately trained and perform routine inspections.
Provide functional expertise and develop technology forums to exchange best practices with site organization.
Implement safe, compliant and efficient procedures.
During active Technical Transfer projects, work with Local Team, Donor Site and Global Technology.
Lead any activities required in support of Process PQMP and PQ/PV Execution through supporting the Validation team developing PQ protocols and PQ summary reports and leading the execution of the PQ protocols.
Deployment of Process Optimization and Lean Culture within all applicable FFL Value Stream operations.
Develop and implement productivity improvement plans using Industrial Excellence methodologies.
Monitor and report progress of safety objectives, performance against schedule and number of defects.
Identify the cause of the problems and continue to educate staff on solutions, accident avoidance and error reductions.
Serve as SME in the development and maintenance of simple, effective, visual LSOPs for Equipment and Areas.
Co-owner for Quality System Events related to FFL Operations.
Support the process for and troubleshoots process deviations and equipment failures.
Promote a people focused culture in line with GSK and site culture.
Support development of others by acting as a coach and mentor.
Allocate important projects and challenging responsibilities to others for the purpose of their development.
Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, GSK standard operating & safety procedures, and industry practice and Industrial Excellence initiatives.
Why you? Biopharmaceutical FFL Production Operations Supervisor Basic
Qualifications:
We are looking for professionals with these required skills to achieve our goals:
BS or BA in a biological, chemical science, or engineering or equivalent technical discipline.
5
years prior pharmaceutical production experience and at least 3 years in a supervisory role leading cross functional teams.
Experience should include supervising and managing production in at least one of the following:
aseptic technique, filling, and lyophilization, product visual inspection, input to scheduling and planning, regulatory compliance.
Supervision to include delegating, training, communicating and prioritizing site objectives, evaluating, coaching and disciplining others.
Biopharmaceutical FFL Production Operations Supervisor Preferred
Qualifications:
If you have the following characteristics, it would be a plus:
Prior experience with project planning software.
Computer skills in Microsoft Office applications and the ability to quickly and easily learn new applications.
Knowledge of cGMPs, and the ability to quickly grasp and apply site policies and procedures and relate them to project scope.
Must possess a technical understanding of industry and scientific principles and practices related to the business.
Maintain a high level of integrity while balancing multiple priorities and responsibilities.
Excellent organizational skills and attention to detail, ability to function in an atmosphere of constant change with detailed accuracy.
Demonstrated interpersonal and leadership skills and ability to lead cross-function / international teams.
Ability to lead the process to generate the exchange of ideas to resolve problems, influence others, analyze data, prioritize solutions, select optimal solutions and implement decisions.
Sense of urgency, flexibility and accountability.
The ability to communicate effectively, both verbally and in writing, to all levels within the organization as well as the skills to communicate site operations to outside agencies.
Ability to follow written procedures and document results in a neat and precise manner.
#MariettaVaccines #vaccinessupplychain #LI-GSK Job Type:
Full-time Pay:
$88,000.
00 - $103,000.
00 per year
Benefits:
401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance Schedule:
8 hour shift Monday to Friday Ability to commute/relocate:
Marietta, PA 17547:
Reliably commute or planning to relocate before starting work (Preferred)
Experience:
Pharmaceutical Production:
5 years (Preferred) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
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