TOLMAR
Manufacturing Lead Operator - Pali
TOLMAR, Windsor, Colorado, us, 80551
Description
Core Hours will be 9:00am - 5:30pm Monday - Friday throughout 2024. At the beginning of 2025, this team will move to 2nd Shift (Monday - Friday 2:00 pm - 10:30 pm)Beginning in 2025, a $1.50 per hour shift differential will be added.Purpose and ScopeThe Lead Operator - Paliperidone supervises and leads processes including set up and operation of processes related to supporting the injectable team, while ensuring that products are made with quality for our patients.Key ResponsibilitiesPerform job responsibilities in accordance with standard operating procedures (SOPs) and production records with an expectation of "Right the First Time".Record data in notebooks or lab forms and accurately calculate results to support process.Perform job in a clean room environment requiring clean room gowning, including but not limited to:
Company-provided ScrubsShoe Covers and Sterile Boot CoversHairnets (and beard covers as applicable)Tyvek CoverallsGlovesFull-face masks/hoodsGogglesChemical Protection PPE
Set up and operate semi-automatic labeling equipment used to label pre-filled syringes.Properly load pre-filled syringes and/or vials into labeling equipment.Set-up and operate semi-automatic packaging equipment used to package pre-filled syringes.Set up and operate semi-automatic filling equipment used to fill syringes for injectable products in both general manufacturing and sterile manufacturing areas.Properly load pre-filled syringes and components into semi-automatic packaging equipment.Formulate bulk materials.Perform facility cleaning of manufacturing areas as required to maintain a cGMP environment and following TOLMAR Standard Operating Procedures.Set up and operate compounding equipment used to produce bulk material for injectable products.Perform final review of processes before the processes can be considered complete.Properly perform job duties as a second checker, ensuring all production activities are correctly performed on batch records in accordance with cGMP standards.Assist with equipment steam in place (SIP) on equipment used for sterile bulking processes.Ensure that product quality adheres to approved specifications.Assist and support any aseptic process development activities/projects as determined by Aseptic Development Operations Manager.Handle hazardous raw materials and cleaning solutions following all applicable safety procedures and policies.Correctly perform inspections of packaged components.Responsible for assembly, disassembly and sanitation of various equipment.Train other Manufacturing Operators and Manufacturing Technicians in the Aseptic Development team to perform job duties related to their position.Review and maintain log books, production records, and associated documents to comply with regulatory requirements, GMPs, and TOLMAR Standard Operating Procedures.Perform visual and physical checks of in-process and finished product as requested.Perform biological sampling of general manufacturing clean room facilities.Perform 100% inspections of pre-filled syringes.Coordinate the daily tasks for Manufacturing Operators and Technicians within assigned process.Coordinate materials, staffing and resources to support line operations and changeovers.Ensure that employees in assigned process follow safe work practices.Perform on floor, in process reviews of production batch records for accuracy and resolve errors in real time.Operate under the guidance of a Manufacturing Manager.Perform other duties as assigned.
Special Skills and KnowledgeMastered knowledge of current Good Manufacturing Procedures (cGMP) as they relate to production packaging activities.Ability to stand for extended periods of time (up to 8 hours or more).Proficient in Microsoft Office (Excel, Word, and Outlook).Ability to maintain focus on detail-oriented, repetitive tasks.Good verbal and written communication skills.Ability to follow and understand written production records and validation protocols.Strong understanding of basic math and writing skills to document production activities in batch records and/or log books.Ability to keep accurate records and able to perform mathematical calculations.Ability to legibly complete required documentation.Excellent attention to detail for documentation in production documents and to inspect produced goods within specified requirements.Capability to operate on a fast-paced manual assembly line using basic production equipment.Ability to learn Aseptic technique and work in an aseptic environment.Ability to wear respirator for extended periods of time while working on tasks (up to 4 hours).Ability to lift up to 40 lbs.Ability to lift arms above shoulder height repetitively for duration of shift while cleaning.Ability to provide support as well as direction to Process Development personnel in the area.Ability to operate new production equipment with little to no previous experience.Ability to lead others in proper aseptic technique and work in an aseptic environment.Ability to quickly make decisions and understand the impact on processes and employees.Technical ability to assemble and disassemble filing equipment.Ability to provide consistent coaching, guidance, development and mentorship to operators and technicians.
Core ValuesThe Lead Operator - Pali is expected to operate within the framework of Tolmar's Core Values:Consistently operate with the highest standards of ethics and compliance.Take ownership of your actions, success and setbacks.Respect each other and understand that honest collaboration is at the heart of our company success.Go the extra mile to make things happen.Be committed to all we do and the patients we serve.Embrace change with enthusiasm.Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.
CommunicationInteract with peers and members of other departments in team settings in a professional manner.Ability to lead by example and have a proven record of excellence in attendance, dependability and safety.
Education
& ExperienceHigh school diploma or equivalent required.Engineering degree and/or equivalent previous experience in engineering or process development preferred but not required.Three or more years of experience in an aseptic (sterile) manufacturing environment preferred.
Additional RequirementsAcceptable results on both a quantitative and verbal assessment test.Valid driver's license and acceptable motor vehicle record may be required.Passing results on an internal inspection qualification for syringe inspection on semi-automated equipment for one syringe type.
Shift work in a manufacturing and warehouse environment.Overtime may be required.
Compensation and BenefitsPay: $30.37 per hour, depending on experienceBenefits summary: https://www.tolmar.com/careers/employee-benefits
Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
Core Hours will be 9:00am - 5:30pm Monday - Friday throughout 2024. At the beginning of 2025, this team will move to 2nd Shift (Monday - Friday 2:00 pm - 10:30 pm)Beginning in 2025, a $1.50 per hour shift differential will be added.Purpose and ScopeThe Lead Operator - Paliperidone supervises and leads processes including set up and operation of processes related to supporting the injectable team, while ensuring that products are made with quality for our patients.Key ResponsibilitiesPerform job responsibilities in accordance with standard operating procedures (SOPs) and production records with an expectation of "Right the First Time".Record data in notebooks or lab forms and accurately calculate results to support process.Perform job in a clean room environment requiring clean room gowning, including but not limited to:
Company-provided ScrubsShoe Covers and Sterile Boot CoversHairnets (and beard covers as applicable)Tyvek CoverallsGlovesFull-face masks/hoodsGogglesChemical Protection PPE
Set up and operate semi-automatic labeling equipment used to label pre-filled syringes.Properly load pre-filled syringes and/or vials into labeling equipment.Set-up and operate semi-automatic packaging equipment used to package pre-filled syringes.Set up and operate semi-automatic filling equipment used to fill syringes for injectable products in both general manufacturing and sterile manufacturing areas.Properly load pre-filled syringes and components into semi-automatic packaging equipment.Formulate bulk materials.Perform facility cleaning of manufacturing areas as required to maintain a cGMP environment and following TOLMAR Standard Operating Procedures.Set up and operate compounding equipment used to produce bulk material for injectable products.Perform final review of processes before the processes can be considered complete.Properly perform job duties as a second checker, ensuring all production activities are correctly performed on batch records in accordance with cGMP standards.Assist with equipment steam in place (SIP) on equipment used for sterile bulking processes.Ensure that product quality adheres to approved specifications.Assist and support any aseptic process development activities/projects as determined by Aseptic Development Operations Manager.Handle hazardous raw materials and cleaning solutions following all applicable safety procedures and policies.Correctly perform inspections of packaged components.Responsible for assembly, disassembly and sanitation of various equipment.Train other Manufacturing Operators and Manufacturing Technicians in the Aseptic Development team to perform job duties related to their position.Review and maintain log books, production records, and associated documents to comply with regulatory requirements, GMPs, and TOLMAR Standard Operating Procedures.Perform visual and physical checks of in-process and finished product as requested.Perform biological sampling of general manufacturing clean room facilities.Perform 100% inspections of pre-filled syringes.Coordinate the daily tasks for Manufacturing Operators and Technicians within assigned process.Coordinate materials, staffing and resources to support line operations and changeovers.Ensure that employees in assigned process follow safe work practices.Perform on floor, in process reviews of production batch records for accuracy and resolve errors in real time.Operate under the guidance of a Manufacturing Manager.Perform other duties as assigned.
Special Skills and KnowledgeMastered knowledge of current Good Manufacturing Procedures (cGMP) as they relate to production packaging activities.Ability to stand for extended periods of time (up to 8 hours or more).Proficient in Microsoft Office (Excel, Word, and Outlook).Ability to maintain focus on detail-oriented, repetitive tasks.Good verbal and written communication skills.Ability to follow and understand written production records and validation protocols.Strong understanding of basic math and writing skills to document production activities in batch records and/or log books.Ability to keep accurate records and able to perform mathematical calculations.Ability to legibly complete required documentation.Excellent attention to detail for documentation in production documents and to inspect produced goods within specified requirements.Capability to operate on a fast-paced manual assembly line using basic production equipment.Ability to learn Aseptic technique and work in an aseptic environment.Ability to wear respirator for extended periods of time while working on tasks (up to 4 hours).Ability to lift up to 40 lbs.Ability to lift arms above shoulder height repetitively for duration of shift while cleaning.Ability to provide support as well as direction to Process Development personnel in the area.Ability to operate new production equipment with little to no previous experience.Ability to lead others in proper aseptic technique and work in an aseptic environment.Ability to quickly make decisions and understand the impact on processes and employees.Technical ability to assemble and disassemble filing equipment.Ability to provide consistent coaching, guidance, development and mentorship to operators and technicians.
Core ValuesThe Lead Operator - Pali is expected to operate within the framework of Tolmar's Core Values:Consistently operate with the highest standards of ethics and compliance.Take ownership of your actions, success and setbacks.Respect each other and understand that honest collaboration is at the heart of our company success.Go the extra mile to make things happen.Be committed to all we do and the patients we serve.Embrace change with enthusiasm.Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.
CommunicationInteract with peers and members of other departments in team settings in a professional manner.Ability to lead by example and have a proven record of excellence in attendance, dependability and safety.
Education
& ExperienceHigh school diploma or equivalent required.Engineering degree and/or equivalent previous experience in engineering or process development preferred but not required.Three or more years of experience in an aseptic (sterile) manufacturing environment preferred.
Additional RequirementsAcceptable results on both a quantitative and verbal assessment test.Valid driver's license and acceptable motor vehicle record may be required.Passing results on an internal inspection qualification for syringe inspection on semi-automated equipment for one syringe type.
Shift work in a manufacturing and warehouse environment.Overtime may be required.
Compensation and BenefitsPay: $30.37 per hour, depending on experienceBenefits summary: https://www.tolmar.com/careers/employee-benefits
Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)