Ferring Pharmaceuticals Inc.
MES eBR Author
Ferring Pharmaceuticals Inc., Parsippany, New Jersey, us, 07054
Job Description:
As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our 'people first' philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world's oldest enemy: disease.As the MES eBR Author, you will be responsible for the design, implementation, and maintenance of the Electronic Batch Records (eBR). This role is critical in ensuring compliance with regulatory standards, optimizing batch manufacturing processes, and enhancing data integrity. The MES eBR Author works closely with cross-functional teams to support production operations.With Ferring, you will be joining a recognized leader, identified as one of "The World's Most Innovative Companies" by Fast Company, and honored by Fortune with inclusion on its "Change the World List," for addressing society's unmet needs. Ferring US is also Great Places to Work Certified, distinguishing it as one of the best companies to work for in the country.Responsibilities:Design and configure MES eBR systems based on business requirements to digitize and automate batch record management, ensuring compliance with industry regulations (e.g., FDA's 21 CFR Part 11).
Create, manage, and maintain electronic batch records, including recipe management, process steps, electronic signatures, and data capture.
Oversee -User -Acceptance Testing of MES recipes to ensure business requirements are achieved.
Plan and execute validation tests (IQ, OQ, PQ) for eBR systems to demonstrate their compliance with regulatory requirements.
Provide training to operators and quality assurance personnel on how to use the eBR system effectively and maintain data integrity.
Provide technical and functional support on day-to-day production issues, as well as periodic on-call support for emergency system issues.
Analyze batch data and historical records to identify trends, deviations, and opportunities for process improvement.
Diagnose and resolve technical issues related to eBR systems, ensuring minimal disruption to manufacturing operations.
Test, validate and demonstrate Master Recipes.
Enterprise Resource Planning (ERP) system master data, including, but not limited to, items, specifications, lookups, list of values, recipes, routings, and formulas.
Maintain comprehensive documentation of system configurations, validation records, and standard operating procedures (SOPs) related to MES eBR systems.
Develop system technical documentation; including but not limited to, functional specifications and UAT test scripts.
Initiate and process change controls related to batch records, ensuring that any deviations, revisions, or updates are properly documented and approved.
Collaborate with cross-functional teams, including manufacturing, quality assurance, and regulatory affairs, to gather information and resolve discrepancies.
Ensure that all batch records and related documentation adhere to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
Maintain data integrity by implementing data review and audit trails within the eBR system.
Archive and maintain electronic batch records in accordance with company and regulatory guidelines.
Identify opportunities for process improvements related to eBR creation and management.
Authoring planned and unplanned deviations including CAPAs (Corrective and Preventative Actions)
Co-ordinate with Product Vendor in presenting incidents and follow-up in getting solutions
Responsible for Recipe Version Controls
Provide direct internal customer support to manufacturing, site planning, inventory control, quality assurance, quality control, global master data management, and IT.
Requirements:Bachelor's degree in relevant field (computer science, chemical engineering, or pharmaceutical sciences)
Minimum 5 years of experience in Pharmaceuticals Industry.
Certificate/ASC/ BS in science-related discipline preferred.
Proficiency in MES eBR software platforms, preferably in Rockwell Automation PharmaSuite.
Knowledge of data integrity principles and strategies to prevent data corruption and maintain data accuracy and consistency.
Strong understanding of regulatory requirements in industries with batch processes, including FDA regulations (e.g., 21 CFR Part 11).
Familiarity with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) to ensure compliance.
Excellent communication skills to collaborate with cross-functional teams, and auditors.
Ability to manage eBR projects, including planning, execution, validation, and documentation.
Attention to detail and strong data-entry skills.
Strong organizational skills and ability to manage multiple tasks and priorities.
Proficiency in Microsoft Office Suite (Word, Excel) or equivalent software.
Physical Requirements:Ability to move around the manufacturing plant, including walking, standing, and sitting for extended periods.
Occasional bending, stooping, or kneeling may be required to access equipment or systems in different locations.
Prolonged periods of sitting and working at a computer terminal.
Repetitive motions related to keyboarding, data entry, and mouse usage.
Occasionally lifting and carrying equipment or documents weighing up to 25 pounds.
Ability to work in a manufacturing environment, which may include exposure to noise, dust, chemicals, or varying temperatures.
Compliance with safety protocols, including the use of personal protective equipment (PPE) as required in specific plant areas.
Periodic movement between different sections of the plant to liaise with production staff, review processes, or validate records.
May involve climbing stairs or accessing elevated workstations.
Place role will be in Parsippany, NJ.Ferring + youAt Ferring, we offer competitive total compensation along with an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work. From working hours that respect your lifestyle, a culture that is welcoming and equitable, and the chance to work with the industry's most impressive people, these are just some of the ways we live our "People First" philosophy.Our Compensation and BenefitsAt Ferring, base salary is one part of our competitive total compensation and benefits package and is determined using a salary range. The base salary range for this role is $61,750 to $143,000, which is the reasonable estimate of the base compensation for this role. The actual amount paid may differ based on non-discriminatory factors such as experience, knowledge, skills, abilities, education and primary work location. Additional compensation for this role will be provided based on competitive annual incentive compensation targets in the form of an annual bonus - payouts are based on individual and company performance.Benefits for this role include comprehensive healthcare (medical, dental, and vision) with a premium differential, inverse to base salary, to be paid by employees, a 401k plan and company match, short and long-term disability coverage, basic life insurance, wellness benefits, reimbursement for certain tuition expenses, sick time of 1 hour per 30 hours worked, vacation time for full time employees to accrue up to 120 hours in the first four (4) years of employment, and 160 hours in the fifth (5th) year of employment as well as 12 to 13 paid holidays per year. We are proud to offer 26 weeks of paid parental leave, learn more about the parental leave offering in our benefits package here.Ferring is an equal opportunity employer. All aspects of employment will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local laws.Join our team and your voice will be heard, and your contributions will be valued. If you love to come up with new ways to make a positive difference and see them through, you will fit right in.We are proud to be an Affirmative Action/Equal Opportunity Employer (including Disability/Protected Veterans). We maintain a drug-free workplace.Location:Parsippany, New Jersey
As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our 'people first' philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world's oldest enemy: disease.As the MES eBR Author, you will be responsible for the design, implementation, and maintenance of the Electronic Batch Records (eBR). This role is critical in ensuring compliance with regulatory standards, optimizing batch manufacturing processes, and enhancing data integrity. The MES eBR Author works closely with cross-functional teams to support production operations.With Ferring, you will be joining a recognized leader, identified as one of "The World's Most Innovative Companies" by Fast Company, and honored by Fortune with inclusion on its "Change the World List," for addressing society's unmet needs. Ferring US is also Great Places to Work Certified, distinguishing it as one of the best companies to work for in the country.Responsibilities:Design and configure MES eBR systems based on business requirements to digitize and automate batch record management, ensuring compliance with industry regulations (e.g., FDA's 21 CFR Part 11).
Create, manage, and maintain electronic batch records, including recipe management, process steps, electronic signatures, and data capture.
Oversee -User -Acceptance Testing of MES recipes to ensure business requirements are achieved.
Plan and execute validation tests (IQ, OQ, PQ) for eBR systems to demonstrate their compliance with regulatory requirements.
Provide training to operators and quality assurance personnel on how to use the eBR system effectively and maintain data integrity.
Provide technical and functional support on day-to-day production issues, as well as periodic on-call support for emergency system issues.
Analyze batch data and historical records to identify trends, deviations, and opportunities for process improvement.
Diagnose and resolve technical issues related to eBR systems, ensuring minimal disruption to manufacturing operations.
Test, validate and demonstrate Master Recipes.
Enterprise Resource Planning (ERP) system master data, including, but not limited to, items, specifications, lookups, list of values, recipes, routings, and formulas.
Maintain comprehensive documentation of system configurations, validation records, and standard operating procedures (SOPs) related to MES eBR systems.
Develop system technical documentation; including but not limited to, functional specifications and UAT test scripts.
Initiate and process change controls related to batch records, ensuring that any deviations, revisions, or updates are properly documented and approved.
Collaborate with cross-functional teams, including manufacturing, quality assurance, and regulatory affairs, to gather information and resolve discrepancies.
Ensure that all batch records and related documentation adhere to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
Maintain data integrity by implementing data review and audit trails within the eBR system.
Archive and maintain electronic batch records in accordance with company and regulatory guidelines.
Identify opportunities for process improvements related to eBR creation and management.
Authoring planned and unplanned deviations including CAPAs (Corrective and Preventative Actions)
Co-ordinate with Product Vendor in presenting incidents and follow-up in getting solutions
Responsible for Recipe Version Controls
Provide direct internal customer support to manufacturing, site planning, inventory control, quality assurance, quality control, global master data management, and IT.
Requirements:Bachelor's degree in relevant field (computer science, chemical engineering, or pharmaceutical sciences)
Minimum 5 years of experience in Pharmaceuticals Industry.
Certificate/ASC/ BS in science-related discipline preferred.
Proficiency in MES eBR software platforms, preferably in Rockwell Automation PharmaSuite.
Knowledge of data integrity principles and strategies to prevent data corruption and maintain data accuracy and consistency.
Strong understanding of regulatory requirements in industries with batch processes, including FDA regulations (e.g., 21 CFR Part 11).
Familiarity with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) to ensure compliance.
Excellent communication skills to collaborate with cross-functional teams, and auditors.
Ability to manage eBR projects, including planning, execution, validation, and documentation.
Attention to detail and strong data-entry skills.
Strong organizational skills and ability to manage multiple tasks and priorities.
Proficiency in Microsoft Office Suite (Word, Excel) or equivalent software.
Physical Requirements:Ability to move around the manufacturing plant, including walking, standing, and sitting for extended periods.
Occasional bending, stooping, or kneeling may be required to access equipment or systems in different locations.
Prolonged periods of sitting and working at a computer terminal.
Repetitive motions related to keyboarding, data entry, and mouse usage.
Occasionally lifting and carrying equipment or documents weighing up to 25 pounds.
Ability to work in a manufacturing environment, which may include exposure to noise, dust, chemicals, or varying temperatures.
Compliance with safety protocols, including the use of personal protective equipment (PPE) as required in specific plant areas.
Periodic movement between different sections of the plant to liaise with production staff, review processes, or validate records.
May involve climbing stairs or accessing elevated workstations.
Place role will be in Parsippany, NJ.Ferring + youAt Ferring, we offer competitive total compensation along with an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work. From working hours that respect your lifestyle, a culture that is welcoming and equitable, and the chance to work with the industry's most impressive people, these are just some of the ways we live our "People First" philosophy.Our Compensation and BenefitsAt Ferring, base salary is one part of our competitive total compensation and benefits package and is determined using a salary range. The base salary range for this role is $61,750 to $143,000, which is the reasonable estimate of the base compensation for this role. The actual amount paid may differ based on non-discriminatory factors such as experience, knowledge, skills, abilities, education and primary work location. Additional compensation for this role will be provided based on competitive annual incentive compensation targets in the form of an annual bonus - payouts are based on individual and company performance.Benefits for this role include comprehensive healthcare (medical, dental, and vision) with a premium differential, inverse to base salary, to be paid by employees, a 401k plan and company match, short and long-term disability coverage, basic life insurance, wellness benefits, reimbursement for certain tuition expenses, sick time of 1 hour per 30 hours worked, vacation time for full time employees to accrue up to 120 hours in the first four (4) years of employment, and 160 hours in the fifth (5th) year of employment as well as 12 to 13 paid holidays per year. We are proud to offer 26 weeks of paid parental leave, learn more about the parental leave offering in our benefits package here.Ferring is an equal opportunity employer. All aspects of employment will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local laws.Join our team and your voice will be heard, and your contributions will be valued. If you love to come up with new ways to make a positive difference and see them through, you will fit right in.We are proud to be an Affirmative Action/Equal Opportunity Employer (including Disability/Protected Veterans). We maintain a drug-free workplace.Location:Parsippany, New Jersey