Greenville, North Carolina, United States · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, pro…
Skills: Process Validation, Project Management, Sterilization Validation, cGMP Compliance, FDA Regulatory Affairs
Greenville, North Carolina, United States · On-site
$20/hr–$35/hr
The starting pay range for this position per hour is $20.75 - $22.75. The full pay range for this position per hour is $20.75 - $35.25 Pay is based on several factors which vary based on position. These include labor mar…
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Greenville, North Carolina, United States · On-site
Work Schedule 12 hr shift/days Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Fluctuating Temps hot/cold, Loud Noises (Equipment/Ma…
Skills: Leadership, GMP Regulations, Quality Systems, Batch Record Documentation, ERP Systems
Greenville, North Carolina, United States · On-site
$95k–$160k/yr
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Greenville, North Carolina, United States · On-site
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Skills: Pharmaceutical Analytical Chemistry, Laboratory Leadership, Project Management, cGMP Compliance, Performance Management
Greenville, North Carolina, United States · On-site
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Skills: Customer Service, Sales Leadership, Team Management, Operational Excellence, Visual Merchandising
Greenville, North Carolina, United States · On-site
$16/hr–$18/hr
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Skills: Leadership, Sales Management, Team Coaching, Customer Experience, KPI Monitoring
Greenville, North Carolina, United States · On-site
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Skills: Judgment, Math, Multitasking, Leadership, Management
Greenville, North Carolina, United States · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facia…
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Greenville, North Carolina, United States · On-site
$76k–$111k/yr
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Greenville, North Carolina, United States · On-site
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Skills: Contamination Control Strategy, Environmental Monitoring, Aseptic Processing, Media Fill Program, Sterilization Processes
Greenville, North Carolina, United States · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our coll…
Skills: cGMP Regulations, Quality Assurance, Sterile Manufacturing, ISO 13485, Batch Disposition
Greenville, North Carolina, United States · On-site
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Greenville, North Carolina, United States · On-site
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Greenville, North Carolina, United States · On-site
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Greenville, North Carolina, United States · On-site
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Greenville, North Carolina, United States · On-site
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Greenville, North Carolina, United States · On-site
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Greenville, North Carolina, United States · On-site
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Greenville, North Carolina, United States · On-site
Primary Office Location:2400 Stantonsburg Road. Greenville, North Carolina. 27834. Join our team. Make a difference - for us and for your future. Position Title: Assistant Branch Manager Business Unit: Retail Reports to:…
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Manage professional staff and contractors responsible for the design, implementation, and documentation of validation for manufacturing equipment, facilities, and processes. Represent the department during FDA audits and meetings while ensuring compliance with regulatory requirements.
Requires a Bachelor's degree in a scientific or engineering discipline and over 10 years of validation experience. Must have at least five years of pharmaceutical/biotechnical industry experience and two years of sterilization validation expertise.
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
Location/Division Specific Information
Greenville, NC | Drug Product - North America
Manage a professional support staff and contractors responsible for process validation of all products marketed by the company and produced by the company, independent contractors, and international company subsidiaries to include the design, implementation, and documentation of validation for manufacturing equipment, utility systems, facilities, and manufacturing processes. Negotiate specific process validation criteria and required external resources. Coordinate interdepartmental process validation programs. Represent the department regarding process validation issues during FDA meetings and audits. Identify and resolve validation issues on a timely basis to avoid regulatory action and make recommendations to senior management. Perform a wide range of managerial duties pertaining to employees including hiring, on-the-job training, career development, appraising performance, promoting, disciplining and firing. Identify opportunities and provide the means for employees to pursue career growth.
Manages the activities of several functional groups of the Validation Department consisting of supervisory, professional, and technical employees. Manages design, implementation, and documentation of validation for manufacturing equipment, utility systems, facilities, and manufacturing processes and computer/information/automation validation.
Develops, approves, executes, and presents all validation master plans and associated documentation in the NDA drug approval process under the FDA Pre-Approval Inspection programs. Represents the department during audits, meetings, and teleconferences regarding process validation issues with the FDA. Provides responses to FDA deficiency letters and audit observations.
Manages multi-disciplinary validation teams, approve testing protocol and establish acceptance criteria for validation projects that impact on the production and control of externally produced products, both in clinical supply and trade product manufacturing. Negotiates the scheduling and commitment of specific resources outside the department required for validation projects.
Audits, evaluates, and qualifies all vendors or contractors. Negotiates validation requirements with these vendors. Plans and establishes technical communications, document flow, testing requirements, and financial resources necessary to produce the validation of the system. Reviews and approves all vendor-supplied documents. Coordinates the audits of inter-departmental validation programs.
Selects bidders, awards and administers contracts involved for consulting, laboratory, and process validation engineering services. Prepares and defends five-year plans and annual budgets for the department by assessing manpower and capital needs
Participates in project team activities and process design to insure Current Good Manufacturing Practices (cGMP) compliance as the validation representative on engineering project teams. Develops and maintains a plant wide change control system to review, authorize and document changes to validated systems.
Provides process validation guidance to domestic contractors and other subsidiaries of the Company supplying US markets regarding current FDA requirements for facility and product approval. Determines FDA’s current regulatory and enforcement policies regarding process validation of drug manufacturing for domestic and foreign sites and implement procedures accordingly.
Represents the Company as an active participant on internal (GQD) and external (ISPE/PDA/PMA) professional committees establishing policy guidelines relating to validation issues.
Complies with all job-related safety and other training requirements.
Performs other duties as assigned.
Bachelor's degree in a scientific, production, or engineering related discipline is highly preferred.
10+ years of validation experience is required, with five to eight years of progressive leadership experience preferred.
Pharmaceutical or Biotechnical Industry experience should exceed five years.
Minimum of two years of demonstrated experience in sterilization validation.
Must have strong project management experience
Equivalent combinations of education, training, and relevant work experience may be considered. 12 to 15+ years of applicable experience may be considered for equivalency to education.
Demonstrated ability to manage and lead professional staff in order to achieve goals, evaluate and resolve complex technical problems.
Ability to motivate, energize, and retain key staff by direct interactions with supervisors and staff.
Outstanding attention to detail and organizational skills.
Self-starter, mature, independent and dependable.
Ability to work in a fast paced environment under pressure, able to multi-task and is results-oriented.
Demonstrated ability to maintain a high degree of confidentiality.
Effective time management and prioritization skills. Requires discretion and independent judgment.
Very high degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters.
Highly effective verbal and written communication skills.
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand and walk; ability to lift and/or carry light objects of up to 25 lbs. for brief periods.
About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.
Offices: 168 Third Avenue, Waltham, MA, US
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