Manufacturing Operator I
Manufacturing operator job at Integra LifeSciences
Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
The Manufacturing Operator follows established Standard Operating Procedures to perform functional testing. Operates CUSA tip testing consoles to ensure function of products. Operates the Cusa Bender. Uses multiple software platforms for completing work such as Windows, Agile, Oracle, and Excel.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Primary responsibilities are to:
+ Ensures completion of tasks as directed by SOPs, routers, prints, work instructions, and manufacturing schedules.
+ May package and test manufactured and purchased parts.
+ May enter and transfer items in Oracle without assistance.
+ Works closely with supervisor on any process challenges that require support from other departments. Follows standard operating procedures and Work Instructions to test manufactured and purchased parts.
+ May operates CUSA Tip testing consoles for both internal and externally manufactured tips.
+ Follows standard operating procedures to support general housekeeping in area.
+ Always observes Company's safety procedures and policy.
+ Performs other duties as required.
+ May operate the Cusa Bender.
Note: Other duties may be assigned as necessary.
**QUALIFICATIONS**
The requirements listed below are representative of the knowledge, skill and/or ability required for this position.
+ Education: High school diploma or GED required with 0 - 2 years of experience.
+ Must be able to read and write in English. Must be able to demonstrate comprehension of written English by successfully completing unassisted written tests, including, but not limited to, Work Instructions and Standard Operating Procedures.
+ Must be able to observe company policies and safety procedures at all times.
+ Must be able to give and welcome constructive feedback; contribute to building a positive team spirit.
+ Must be able to treat others with respect; work with integrity and ethically; uphold organizational values.
**TOOLS AND EQUIPMENT USED**
+ CUSA tip testing consoles, Bending, and washing machines and personal computers. Use of Personal Protective Equipment (PPE) when required. Ability to utilize a desktop computer with typical business programs installed, including spreadsheets, word processing and Oracle systems.
+ Strong computer skills are required. Knowledge and experience with MRP/ERP systems is a plus.
Salary Pay Range:
$16.68 - $22.12 USD Hourly
Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training **.** In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation **.** Your recruiter can share more about the specific salary range for your preferred location during the hiring process.
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, Employees are eligible for the following *******************************************
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law (********************* | EOE including Disability/Protected Veterans (********************************************************************
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (************************************************** . If you have difficulty using our online system due to a disability and need an accommodation, please email us at ***********************.
Unsolicited Agency Submission
Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.
Integra - Employer Branding from Integra LifeSciences on Vimeo (*****************************************
Manufacturing Operator
Carpinteria, CA jobs
Complete production assignments manually or utilizing filling/labelling/packaging equipment. Count, weigh, and measure materials to ensure batches manufactured contain proper materials and quantities.
Completes/maintains device history records. Performs line clearance and verifications. Responsible for performing continuous inspection of labels, vials, sub-assemblies, or final assemblies of Agilent products.
Recognize nonconformances and/or production issues and relay to the supervisor.
Maintain a clean, safe, and organized manufacturing area.
Coordinates materials movement. Receives, stores, and distributes materials and inventory. Performs a variety of administrative tasks, including maintaining inventory accuracy. Performs kitting of materials for production. Interfaces with the warehouse.
Complete training and learning assignments in the “Learning @ Agilent” platform as required.
Participate in and support continuous improvement and digital innovation efforts.
May perform transactions in the ERP system.
Qualifications
Ability to stand or sit for long periods of time.
Frequent bending, reaching, and lifting to 50 lbs.
Frequent exposure to general laboratory and biochemical hazards, contact with toxic chemicals, suspected carcinogenic and caustic materials, and daily exposure to 2-8 °C. C temperatures in cold rooms and exposure to fumes and odors.
May require specialized training/certification, or equivalent combination of education and experience.
Some previous manufacturing experience preferred but not required.
Additional Details
This job has a full time weekly schedule. Applications for this job will be accepted until at least November 6, 2025 or until the job is no longer posted.The full-time equivalent pay range for this position is $22.22 - $34.72/hr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: ************************************* Agilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_******************* or contact ***************. For more information about equal employment opportunity protections, please visit *************************************** Required: NoShift: SwingDuration: No End DateJob Function: Manufacturing
Auto-ApplyMachine Operator - Converter
Lake in the Hills, IL jobs
Full-time Description
Converting Machine Operator
Schedule: Monday-Friday 6:00 am - 2:30 pm OR 2:00 pm - 10:30 pm Compensation: $17.40/hr + shift differential if applicable
Do you want to work in a hands-on environment where you will work alongside others to make products used in well-known companies? At AFC you will be able to assist other workers in the fabrication process, you will get the experience of working in a manufacturing company, and be able to learn while on the job. As a Converter, you will operate a machine to scan and rewind various lengths of material such as PTFE and silicone-coated fiberglass cloth and other PTFE and silicone-coated products and slit materials into various lengths.
What You'll Do
Mount roll of material on machine shafts, re-roll and inspect material while rewinding, and measure material to desire lengths.
Start machine and observe flow of material through machine to detect irregular cutting and winding.
Responsible for maintenance and some repairs of rewind machine.
Operate slitter, placing correct dimensions and specification into the computer.
Fill orders for zone tape, sponge, and tubing.
Clean and maintain work area, machines, tools, and equipment.
Inventory management of materials and finished goods in the converting area
Correctly completes all inventory transactions in the ERP system.
What You'll Bring
One year of machine operator work experience and/or training preferred.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
Ability to compute rate, ratio, and percent.
High school diploma or GED not required, but preferred
Must be able to train on 1st shift for up to 4 weeks.
Why Join AFC?
Stability & Growth: Industry leader with over 30 years of proven success
Full Benefits (Medical, Dental, Vision) - starting 1st of the month after 30 days
401(k) with company match
Generous PTO & 10 Paid Holidays
Annual Safety Shoe & Gym Reimbursement
Tuition Reimbursement & In-House Training (AFC University)
$2,000 Referral Bonus Program
About Us
AFC Materials Group, headquartered in Lake in the Hills, IL, is a global leader in high-temperature and non-stick composite solutions. Since 1988, we've partnered with OEMs, distributors, and end users to solve complex production challenges through expert coating, converting, and fabrication capabilities. For over 30 years, we've built a reputation on innovation, reliability, and a strong commitment to our people and customers. Join a team where growth, quality, and forward-thinking are at the core of what we do.
AFC is an Equal Opportunity Employer, including disability/vets
AFC is a Drug-free workplace
Machine Operator - Converter
Lake in the Hills, IL jobs
Job DescriptionDescription:
Converting Machine Operator
Schedule: Monday-Friday 6:00 am - 2:30 pm OR 2:00 pm - 10:30 pm Compensation: $17.40/hr + shift differential if applicable
Do you want to work in a hands-on environment where you will work alongside others to make products used in well-known companies? At AFC you will be able to assist other workers in the fabrication process, you will get the experience of working in a manufacturing company, and be able to learn while on the job. As a Converter, you will operate a machine to scan and rewind various lengths of material such as PTFE and silicone-coated fiberglass cloth and other PTFE and silicone-coated products and slit materials into various lengths.
What You'll Do
Mount roll of material on machine shafts, re-roll and inspect material while rewinding, and measure material to desire lengths.
Start machine and observe flow of material through machine to detect irregular cutting and winding.
Responsible for maintenance and some repairs of rewind machine.
Operate slitter, placing correct dimensions and specification into the computer.
Fill orders for zone tape, sponge, and tubing.
Clean and maintain work area, machines, tools, and equipment.
Inventory management of materials and finished goods in the converting area
Correctly completes all inventory transactions in the ERP system.
What You'll Bring
One year of machine operator work experience and/or training preferred.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
Ability to compute rate, ratio, and percent.
High school diploma or GED not required, but preferred
Must be able to train on 1st shift for up to 4 weeks.
Why Join AFC?
Stability & Growth: Industry leader with over 30 years of proven success
Full Benefits (Medical, Dental, Vision) - starting 1st of the month after 30 days
401(k) with company match
Generous PTO & 10 Paid Holidays
Annual Safety Shoe & Gym Reimbursement
Tuition Reimbursement & In-House Training (AFC University)
$2,000 Referral Bonus Program
About Us
AFC Materials Group, headquartered in Lake in the Hills, IL, is a global leader in high-temperature and non-stick composite solutions. Since 1988, we've partnered with OEMs, distributors, and end users to solve complex production challenges through expert coating, converting, and fabrication capabilities. For over 30 years, we've built a reputation on innovation, reliability, and a strong commitment to our people and customers. Join a team where growth, quality, and forward-thinking are at the core of what we do.
AFC is an Equal Opportunity Employer, including disability/vets
AFC is a Drug-free workplace
Requirements:
Manufacturing Associate, LNP
Framingham, MA jobs
Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California.
Position Summary
Reporting to the Manufacturing Sr Manager, the Manufacturing Associate will perform manufacturing activities associated with LNP GMP manufacturing within a state-of-the-art manufacturing facility at 33 New York Ave in Framingham, MA. A successful candidate will be responsible for the manufacture of LNP therapies for clinical studies and as a commercial product. This role requires clear communication across multiple departments for the execution of daily activities. The ideal candidate will have experience successfully performing formulated LNP Manufacturing within a GMP environment.
Responsibilities
* Perform clinical / commercial product manufacturing for LNP therapies according to cGMP standards and SOPs including Lipid and RNA Prep, T-Mix, and TFF operations
* Perform aseptic vial filling, visual inspection, cryopreservation, process reagent formulation, and material kitting.
* Transfer raw material inside cleanroom suite using sanitizing reagents or equipment.
* Participates in technology transfer from Process Development to the Manufacturing group.
* Assist in the life cycle development of Standard Operating Procedures (SOPs) for manufacturing in collaboration with PD / MSAT and Quality Systems groups.
* Ensures all materials and equipment are identified and available in time for manufacturing operations.
* Execute standard work per manufacturing schedule
* Participate in Quality investigations and resolutions.
* Ensure cGMP compliance through consistent execution.
* Other duties and projects as assigned to meet departmental requirements.
Minimum Qualifications
* Certificate, associate's degree or higher in biological sciences or related fields and 2-5 years of relevant Manufacturing experience or related fields
* Available to work a flexible schedule as needed.
* Ability to don cleanroom garments and work within a classified environment (Grade B and C)
* Knowledge of GMP and industry standards
* T-Mix and TFF experience preferred
* Fluency in Windows and Microsoft Office applications
* Attentive to detail and accuracy
* Ability to effectively communicate and collaborate with internal stakeholders is essential
* Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view. Ability to execute and follow-through to completion
* Ability to lift 40 pounds
* Ability to stand for 6 hours in a clean room environment
* Self-driven, independently motivated, data driven and excellent problem-solving ability
Competencies
* Collaborative - Openness, One Team
* Undaunted - Fearless, Can-do attitude
* Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems.
* Entrepreneurial Spirit - Proactive. Ownership mindset.
Due to the nature of their work, our manufacturing and lab-based positions are located fully on-site.
Manufacturing Associate: Base pay range of $40.00 per hour to $44.00 per hour + bonus, equity and benefits.
The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.
CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
To view our Privacy Statement, please click the following link: ***********************************************
Manufacturing Associate, LNP
Framingham, MA jobs
Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California.
Position Summary
Reporting to the Manufacturing Sr Manager, the Manufacturing Associate will perform manufacturing activities associated with LNP GMP manufacturing within a state-of-the-art manufacturing facility at 33 New York Ave in Framingham, MA. A successful candidate will be responsible for the manufacture of LNP therapies for clinical studies and as a commercial product. This role requires clear communication across multiple departments for the execution of daily activities. The ideal candidate will have experience successfully performing formulated LNP Manufacturing within a GMP environment.
Responsibilities
Perform clinical / commercial product manufacturing for LNP therapies according to cGMP standards and SOPs including Lipid and RNA Prep, T-Mix, and TFF operations
Perform aseptic vial filling, visual inspection, cryopreservation, process reagent formulation, and material kitting.
Transfer raw material inside cleanroom suite using sanitizing reagents or equipment.
Participates in technology transfer from Process Development to the Manufacturing group.
Assist in the life cycle development of Standard Operating Procedures (SOPs) for manufacturing in collaboration with PD / MSAT and Quality Systems groups.
Ensures all materials and equipment are identified and available in time for manufacturing operations.
Execute standard work per manufacturing schedule
Participate in Quality investigations and resolutions.
Ensure cGMP compliance through consistent execution.
Other duties and projects as assigned to meet departmental requirements.
Minimum Qualifications
Certificate, associate's degree or higher in biological sciences or related fields and 2-5 years of relevant Manufacturing experience or related fields
Available to work a flexible schedule as needed.
Ability to don cleanroom garments and work within a classified environment (Grade B and C)
Knowledge of GMP and industry standards
T-Mix and TFF experience preferred
Fluency in Windows and Microsoft Office applications
Attentive to detail and accuracy
Ability to effectively communicate and collaborate with internal stakeholders is essential
Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view. Ability to execute and follow-through to completion
Ability to lift 40 pounds
Ability to stand for 6 hours in a clean room environment
Self-driven, independently motivated, data driven and excellent problem-solving ability
Competencies
Collaborative - Openness, One Team
Undaunted - Fearless, Can-do attitude
Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems.
Entrepreneurial Spirit - Proactive. Ownership mindset.
Due to the nature of their work, our manufacturing and lab-based positions are located fully on-site.
Manufacturing Associate: Base pay range of $40.00 per hour to $44.00 per hour + bonus, equity and benefits.
The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.
CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
To view our Privacy Statement, please click the following link: ***********************************************
Auto-ApplyManufacturing Operator / Production Assembler
Wayne, NJ jobs
With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Overview
Responsible for assembling products and recording required information to meet production requirements and quality standards. Contribute to operation of production cell, and assure compliance with GMP, ISO, ESD and all other regulatory requirements.
Job Responsibilities and Essential Duties
* Ability to follow assembly drawings, parts lists and process papers
* Ability to work independently, or as part of a group and display a high quality of skill in both mechanical and electronic assembly with a minimum of supervision.
* Ability to inspect work and materials
* Ability to use basic test and measurement equipment
* Full understanding of document control procedures
* Ability to train other Manufacturing Operators
* Demonstrated ability to follow and implement GMP, ESD and all other applicable regulatory requirements
* Material control responsibility
* Determine if components and/or assemblies meet specification and reject if necessary.
* Escalate issues to Manager as necessary
Minimum Requirements
* High School diploma preferred
* 1-3 years previous experience in a manufacturing environment
* Ability to work the 7AM - 3:30PM shift
* Electromechanical assembly experience strongly preferred
* Must have basic computer skills, SAP experience a plus
* Must be able to work in a team environment
Required Knowledge, Skills and Abilities
* Ability to follow assembly drawings, parts lists and process papers
* Ability to work independently, or as part of a group and display a high quality of skill in both mechanical and electronic assembly with a minimum of supervision.
* Ability to inspect work and materials
* Ability to use basic test and measurement equipment
* Full understanding of document control procedures
* Ability to train other Manufacturing Operators
* Demonstrated ability to follow and implement GMP, ESD and all other applicable regulatory requirements
* Material control responsibility
* Determine if components and/or assemblies meet specification and reject if necessary.
* Escalate issues to Manager as necessary
Pay Range: $20.60/hour - $25.00/hour
#LI-BS1
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Benefits at Getinge:
At Getinge, we offer a comprehensive benefits package, which includes:
* Health, Dental, and Vision insurance benefits
* 401k plan with company match
* Paid Time Off
* Wellness initiative & Health Assistance Resources
* Life Insurance
* Short and Long Term Disability Benefits
* Health and Dependent Care Flexible Spending Accounts
* Commuter Benefits
* Parental and Caregiver Leave
* Tuition Reimbursement
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
Machine Operator - Converter
Crystal Lake, IL jobs
Converting Machine Operator
Schedule: Monday-Friday 6:00 am - 2:30 pm OR 2:00 pm - 10:30 pm Compensation: $17.40/hr + shift differential if applicable
Do you want to work in a hands-on environment where you will work alongside others to make products used in well-known companies? At AFC you will be able to assist other workers in the fabrication process, you will get the experience of working in a manufacturing company, and be able to learn while on the job. As a Converter, you will operate a machine to scan and rewind various lengths of material such as PTFE and silicone-coated fiberglass cloth and other PTFE and silicone-coated products and slit materials into various lengths.
What You'll Do
Mount roll of material on machine shafts, re-roll and inspect material while rewinding, and measure material to desire lengths.
Start machine and observe flow of material through machine to detect irregular cutting and winding.
Responsible for maintenance and some repairs of rewind machine.
Operate slitter, placing correct dimensions and specification into the computer.
Fill orders for zone tape, sponge, and tubing.
Clean and maintain work area, machines, tools, and equipment.
Inventory management of materials and finished goods in the converting area
Correctly completes all inventory transactions in the ERP system.
What You'll Bring
One year of machine operator work experience and/or training preferred.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
Ability to compute rate, ratio, and percent.
High school diploma or GED not required, but preferred
Must be able to train on 1st shift for up to 4 weeks.
Why Join AFC?
Stability & Growth: Industry leader with over 30 years of proven success
Full Benefits (Medical, Dental, Vision) - starting 1st of the month after 30 days
401(k) with company match
Generous PTO & 10 Paid Holidays
Annual Safety Shoe & Gym Reimbursement
Tuition Reimbursement & In-House Training (AFC University)
$2,000 Referral Bonus Program
About Us
AFC Materials Group, headquartered in Lake in the Hills, IL, is a global leader in high-temperature and non-stick composite solutions. Since 1988, we've partnered with OEMs, distributors, and end users to solve complex production challenges through expert coating, converting, and fabrication capabilities. For over 30 years, we've built a reputation on innovation, reliability, and a strong commitment to our people and customers. Join a team where growth, quality, and forward-thinking are at the core of what we do.
AFC is an Equal Opportunity Employer, including disability/vets
AFC is a Drug-free workplace
Manufacturing Technician - Hiring Now
Milford, MA jobs
About this opportunity : As a Manufacturing Technician II, you'll be responsible for the implementation of assigned production operations working within defined production schedules in a cGMP environment.This is a 2nd shift position and comes with a 15% shift differential.
Key Responsibilities:
Maintain a clean and organized work environment. Responsible for following GMP and safety cultures, procedures, and regulations.
Identify and submit safety hazards and incidents.
Complete GMP documentation in a compliant manner. May review less complex documentation like logbooks.
May revise procedures under direct supervision.
May participate in investigations. May execute CAPA tasks.
Identify and implement small continuous improvement projects.
Responsible for assigned production activity and ensuring training is compliant prior to performing operations.
Problem solving: basic understanding of process and documentation. Ability to identify abnormal results and report to higher position.
Proficient in the assigned area of the process.
Required Skills/Abilities:
Minimum education requirements: high school diploma or equivalent with college level Chemistry degree or equivalent work experience.
A biotechnology certificate or college degree is preferred.
Must have knowledge of basic laboratory instrumentation such as use of pH meter, UV instrumentation, and solution delivery systems (process skids).
Two plus years of experience in cGMP manufacturing environment. Performance/other experience can be considered pending manager discretion.
The annualized salary range for this roles is $61,700.00 - $75,600.00.
Manufacturing Operator I
Denton, TX jobs
Web Industries Manufacturing Operators are responsible for manufacturing product by following standard work and manufacturing specifications. This position has a key role in meeting our production needs and working as a team with others to operate as efficiently as possible.
PRINCIPAL DUTIES AND ESSENTIAL FUNCTIONS:
Operates Machinery:
Set-up machine to machine specifications and best practices to meet production specifications
Responsible to convert the correct materials to work order specifications
Responsible for execution of trials and recording of results as needed
Ensure that quality documents are completed and legible at appropriate stages of production
Train Manufacturing Associates using the passport program
Continually work towards passport program Manufacturing Operator I completion
Safety and Environmental Compliance:
Complies with safety rules and standards
Immediately reports any unsafe conditions to the shift supervisor, group lead or manager
Reports any concerns of potentially harmful environmental practices to the Shift Supervisor and/or Management
Ensure compliance with standard work and other applicable manufacturing standards
Identifies and communicates near misses and safety incidents
Manage Production Schedule:
Run any production line as required
Support initiatives from other departments; e.g. Quality, Engineering, Customer Care etc
Ensure compliance with production schedule and communicate when output targets are not met
Support material handling as required
Manage downtime effectively (efficient changeovers / start-ups)
Process Improvement, and Maintenance:
Support continuous improvement projects to address downtime and inefficiencies
Identify and communicate areas for Kaizen or other continuous improvement initiative
Maximize through-put and uptime
Identify and communicate maintenance issues with the production lines (enter work orders)
Troubleshoot machines as required, request support for issues identified
Training:
Keep passport up to date and obtain sign-offs when competent
Train other employees and sign off passports
Visual Factory Goal:
Keep the factory “customer ready” at all times
Manage all point of use storage systems and ensure they are properly filled
Assist in managing all Kanban's
Employee Ownership Behaviors:
Lead by example in demonstrating the following;
Dependable : Behaves in a sensible way and does what they say and leads by example
Judgement: Uses Good Judgement by considering safety implications, decision making, using KT and other tools to drive sound decisions
Can Do Mentality: Is able to step in to situation and mentor how to accomplish task and demonstrates this behavior by using know LEAN, Problem Solving and methodical learned tools
Communication Skills :
Is a good communicator (verbally, written to be well equipped with the tools to communicate effectively and convey information so that is received and understood
Makes Sound Decisions. Able to make purposeful selection from among a set of alternatives in light of a given object
Self-Starter. Is able to work cooperatively as a member of a group to achieve a common goal
Strong Delegator. Ability to position resources in areas that will be beneficial to production while complying with safety and proper training
Team Player. Able to work cooperatively as a member of a group to achieve a common goal and uphold our culture
Performs any other function or responsibility as assigned
Additional REQUIRED Qualifications/Skills:
High School diploma or GED
1-2 years manufacturing experience
Ability to read, write and speak and understand English
Ability to read and understand complex work instructions
Basic computer/math skills; Word, Excel, Outlook etc
Self-Motivated and detail oriented
Team oriented
Ability to lift 50Ibs to 75Ibs (location dependent)
US Citizen or Permanent Resident
Additional PREFERRED Qualifications/Skills:
Track record of strong communication and above average job performance
Experience manufacturing flexible materials
Experience in Aerospace, Medical or Wire and Cable manufacturing
All applicants must be eligible to work on military contracts.
Auto-ApplySupervisor, Manufacturing
Newark, NJ jobs
Why join Hologic:
You will have the opportunity to get in on the ground floor at a high growth world class manufacturing facility working on life-saving medical devices with potential for future growth. This is a great opportunity to enhance your manufacturing operation skills and knowledge to further your career.
At Hologic, our employees have a unique sense of pride and fulfillment in their work because we are a force for good. As an innovative global medical technology company, we specialize in women's health and wellbeing and create products that detect and diagnose disease earlier and with more certainty than ever before. Our employees in Newark, Delaware support the production of the “Coolest Thing Made in Delaware,” a recent honor awarded to us by the Delaware State Chamber of Commerce for our 3Dimensions Mammography System that helps find breast cancer.
What to expect:
The Supervisor, Manufacturing directs the development and implementation of activities in production area(s) to meet production goals, quality, and cost objectives. Prioritizes production schedules based on product introduction, equipment efficiency, and materials supply. Plans and administers procedures and budgets. Makes budgetary recommendations and at higher levels, controls capital expenditures and direct/indirect labor. Develops schedules and manpower requirements for assigned areas. Selects, develops, and evaluates personnel to ensure the efficient operation of the function.
Receives assignments in the form of objectives with goals and the process by which to meet goals. Directs subordinates to complete assignments using established guidelines, procedures, and policies. Administers company policies that directly affect subordinate employees. Management reviews work to measure meeting of objectives. Provides immediate supervision/acts as advisor to a unit or group of employees, and may become actively involved, as required, to meet schedules and resolve problems.
Works on issues where analysis of situation or data requires review of relevant factors. Follows established practices and procedures in analyzing situations and may exercises judgement within defined policies to determine appropriate action. Monitors daily operations of a unit or sub-unit. Requires full knowledge of own area of functional responsibility.
What we expect:
Accountable for department oversight. Will work collaboratively with Group Leads and manufacturing associates to improve team engagement, product quality and cost efficiency.
Responsible for reviewing, evaluating, and implementing changes and specification requirements.
Take appropriate actions to ensure product manufacturing volumes are align with the planning provided.
Actively participate in building the forecast and budget
Drive systematic improvements through analysis of KPIs and other performance data.
Interface with manufacturing engineering, equipment engineering, management to improve cycle time, tool availability, process, and product yield.
Transfer process know-how to manufacturing by creating SOPs and training production operators.
Partner with other functional teams to continuously improve and develop manufacturing capability to support both existing and future production.
Participate in NPI projects and drive successful introduction of new products and production concepts from design phase to volume production.
Promote compliance-based culture, ensure timely and effective investigation and root cause identification and resolution of manufacturing non-conformances and corrective preventative action plans (CAPA)
Work with department manager to develop and drive implementation of lean manufacturing across the organization.
Establish a strong network across various organizations such as Supply Chain, R&D, Sourcing, Finance, etc to drive end-to-end cross functional improvements of the business.
Recruit, lead and develop the personnel in the department.
Education & Experience:
Preferred Minimum Non-Technical Degree: AA/AS Degree, possibly BA/BS
Preferred Minimum Non-Technical Degree: 5+ Years
Experience with manufacturing scheduling and working in a lean manufacturing environment.
Experience with high precision mechanical, electrical industrial products.
Must be self-motivated with capability to work in a fast-paced environment.
Skills
Strong attention to detail with analytical and problem-solving skills
Proven leadership behavior with demonstrated ability to attract, lead and develop talent.
Ability to anticipate and resolve conflicts while leveraging unique team talents to enhance engagement.
Demonstrated ability to attract, lead and develop talent.
Working knowledge of SPC (statistical process control) principles
Working knowledge of industrial engineering
Problem solving
The annualized base salary range for this role is $75,600 to $120,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand..
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
#LI-PR1
Must follow all applicable FDA regulations and ISO requirements.
Hologic is an equal opportunity employer inclusive of female, minority, disabled and veterans, (F/M/D/V)
Auto-ApplySupervisor, Manufacturing
Newark, NJ jobs
Why join Hologic:
You will have the opportunity to get in on the ground floor at a high growth world class manufacturing facility working on life-saving medical devices with potential for future growth. This is a great opportunity to enhance your manufacturing operation skills and knowledge to further your career.
What to expect:
Directs the development and implementation of activities in production area(s) to meet production goals, quality, and cost objectives. Prioritizes production schedules based on product introduction, equipment efficiency, and materials supply. Plans and administers procedures and budgets. Makes budgetary recommendations and at higher levels, controls capital expenditures and direct/indirect labor. Develops schedules and manpower requirements for assigned areas. Selects, develops, and evaluates personnel to ensure the efficient operation of the function.
Receives assignments in the form of objectives with goals and the process by which to meet goals. Directs subordinates to complete assignments using established guidelines, procedures, and policies. Administers company policies that directly affect subordinate employees. Management reviews work to measure meeting of objectives. Provides immediate supervision/acts as advisor to a unit or group of employees, and may become actively involved, as required, to meet schedules and resolve problems.
Works on issues where analysis of situation or data requires review of relevant factors. Follows established practices and procedures in analyzing situations and may exercises judgement within defined policies to determine appropriate action. Monitors daily operations of a unit or sub-unit. Requires full knowledge of own area of functional responsibility.
What we expect:
Accountable for department oversight. Will work collaboratively with Group Leads and manufacturing associates to improve team engagement, product quality and cost efficiency.
Responsible for reviewing, evaluating, and implementing changes and specification requirements.
Take appropriate actions to ensure product manufacturing volumes are align with the planning provided.
Actively participate in building the forecast and budget
Drive systematic improvements through analysis of KPIs and other performance data.
Interface with manufacturing engineering, equipment engineering, management to improve cycle time, tool availability, process, and product yield.
Transfer process know-how to manufacturing by creating SOPs and training production operators.
Partner with other functional teams to continuously improve and develop manufacturing capability to support both existing and future production.
Participate in NPI projects and drive successful introduction of new products and production concepts from design phase to volume production.
Promote compliance-based culture, ensure timely and effective investigation and root cause identification and resolution of manufacturing non-conformances and corrective preventative action plans (CAPA)
Work with department manager to develop and drive implementation of lean manufacturing across the organization.
Establish a strong network across various organizations such as Supply Chain, R&D, Sourcing, Finance, etc to drive end-to-end cross functional improvements of the business.
Recruit, lead and develop the personnel in the department.
Education & Experience:
Preferred Minimum Non-Technical Degree: AA/AS Degree, possibly BA/BS
Preferred Minimum Non-Technical Degree: 5+ Years
Experience with manufacturing scheduling and working in a lean manufacturing environment.
Experience with high precision mechanical, electrical industrial products.
Must be self-motivated with capability to work in a fast-paced environment.
The annualized base salary range for this role is $75,600 to $110,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand..
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
#LI-PR1
Must follow all applicable FDA regulations and ISO requirements.
Hologic is an equal opportunity employer inclusive of female, minority, disabled and veterans, (F/M/D/V)
Auto-ApplySoftgel Manufacturing Supervisor
Vista, CA jobs
Schedule: Wednesday to Sunday
Hours: To be discussed with Manager
The Softgel Manufacturing Supervisor oversees the production of softgels and other products, with a strong focus on the compounding and encapsulation processes, ensuring that operations run smoothly and efficiently in compliance with company SOPs (Standard Operating Procedures) and cGMP (Current Good Manufacturing Practices).
ESSENTIAL FUNCTIONS
Reasonable Accommodations Statement
To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions.
Role Competencies/Expectations/Essential Functions:
Oversees daily manufacturing operations. Monitors production schedules, and organizes workflow.
Ensures high product quality and adherence to quality standards.
Oversees and ensures proper execution of the softgel compounding process, including weighing, mixing, and verifying raw materials according to batch records.
Monitors compounding and encapsulation parameters to maintain product quality and compliance with specifications.
Troubleshoots equipment and process to comply with company SOP's
Ensures compliance with health and safety regulations
Follows all company SOPs and GMPs.
Reports any deviation in process to supervisor and QA/QC.
Completes and fills out required reports.
Liaison between production and maintenance.
Implements process improvements to minimize costs and enhance production quality
Responsible for safety and well-being of His/Her co-workers.
Reports safety hazards to Supervisor and Maintenance.
Trains and coaches employees.
Ensure the safe use of equipment and schedule regular maintenance
Check production output according to specifications
Completes employee performance evaluation forms and conducts employee performance evaluation meetings
Identify issues in efficiency and suggest improvements
Train new employees on how to safely use machinery and follow procedures
Enforce strict safety guidelines and company standards
Performs any other duties as assigned.
POSITION QUALIFICATIONS
Create Vision & Strategic Intent - As a leader at Nordic Naturals, you translate your team's vision into clear objectives and key results, aligning with long-term company goals. You ensure this vision is well defined and understood by all stakeholders. By understanding external trends, you continually seek ways to enhance competitive advantage, drive efficiency, and improve processes. You align your team's strategy with the overall company strategy and create a compelling vision that inspires and motivates people.
Foster integrity and trust - As a leader at Nordic Naturals, you earn and maintain your team's trust through honest communication, transparency and fairness. You understand the importance of leading by example, prioritizing doing the right thing, even when it's difficult, and following through with a commitment to ethical principles. You demonstrate accountability and owning your mistakes. You ensure transparency by openly communicating about successes and failures, creating a culture of learning rather than blame.
Effective Communication - As a leader at Nordic Naturals, you actively listen with curiosity, show genuine interest in others perspectives, and foster inclusive dialogue. Your nonverbal cues, like positive body language and eye contact, reinforce your message. You balance assertiveness with respect, offering and receiving constructive feedback to maintain a supportive and collaborative environment.
Demonstrate Business Acumen - As a leader at Nordic Naturals, you understand company operations and objectives, guiding your team on the steps to success. You analyze performance metrics and market trends to make informed decisions and adapt to changes. You optimize spending, manage costs, and develop strategies to enhance profitability. By fostering a results-oriented culture, you keep the team focused on key initiatives and deliver measurable outcomes.
Build a Culture of Accountability - As a leader at Nordic Naturals, you take responsibility for your actions, foster trust, and ensure transparency by communicating openly about successes and failures. You set clear expectations, provide resources, and follow through on commitments, demonstrating reliability. You encourage team members to own their roles, give constructive feedback, and recognize contributions to motivate and empower them.
Use Intellectual & Critical Thinking - As a leader at Nordic Naturals, you grasp complex information, identify patterns, and balance research with swift decision-making. You distill data to uncover core issues, use systems thinking to understand organizational impacts, and make sound judgments even amid uncertainty.
Be Solution Driven - As a leader at Nordic Naturals, you approach challenges with a positive attitude, encourage collaboration, and empower your team to tackle obstacles proactively. You make timely decisions, resolve conflicts fairly, and foster a positive, trusting work environment.
Takes Initiative - As a leader at Nordic Naturals, you proactively identify opportunities, innovative, and drive continuous improvement. You inspire a culture of proactive problem- solving, motivating your team to be self-driven and resourceful, ensuring the organization stays ahead in achieving its goals.
Possess Selfawareness & Social Intelligence - As a leader at Nordic Naturals, you are self-aware and foster strong relationships by responding appropriately to social situations. You model humility and openness, creating a culture of trust and transparency. You motivate others, promote collaboration, and make team members feel valued through empathy, active listening, curiosity, clear communication, and recognition.
Coach, Develop, Mentor and Provide Feedback - As a leader at Nordic Naturals, you invest in your team's growth through regular feedback, personalized guidance, and skill-building opportunities. You foster a supportive environment for learning, empower team members in their development, and build strong, mentoring relationships. Your commitment enhances skills, confidence, and team cohesion, contributing to a culture of continuous learning.
POSITION QUALIFICATIONS
SKILLS & ABILITIES
Education:
At least high school diploma
Experience:
3+ years' direct experience with softgel manufacturing, including compounding, is required.
Familiarity with a softgel manufacturing process is a must.
Ability to create accountability and to lead by example
Strong team building, decision-making and people management skills
Physically able to lift, bend, stoop, climb, and reach.
Some mechanical experience is preferred.
Ability to read and write English.
Ability to understand and follow all company SOPs and cGMP guidelines.
Intermediate math skills (Multiplication, Division, Conversions and understanding weights and measures).
Auto-ApplySupervisor, Manufacturing Upstream
Tustin, CA jobs
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.
Your Role:
The Supervisor, Manufacturing Upstream is responsible for the supervision of Upstream manufacturing staff and operations as well as regularly performing hands on operational activities. This includes ensuring that production is maintained in full cGMP compliance through on the floor observation, direction, and participation.
* Schedule, plan and coordinate production activities.
* Perform cell culture and bioreactor operations from thaw through TFF on the production floor, as required.
* Responding to process alarms by arriving on-site during non-business hours
* cGMP documentation.
* Revise initiate and review Batch Production Records (BPRs), Standard Operating Procedures (SOPs), forms and Batch History Records (BHRs).
* Identify, escalate, and write deviation reports (IRs/DRs/CAPAs). Follow through on corrective and preventative actions to ensure cGMP compliance.
* Manage the development of SOPs to ensure all manufacturing operations comply with internal and external regulatory agencies.
* Coordinate manufacturing, validation, and maintenance activities with supporting departments.
* Oversee the setup of new manufacturing processes and critical equipment.
* Identify the technical, procedural and equipment issues that hinder production and compliance.
* Communicate with team members, supervisor and members of other departments, as appropriate, to assure prompt resolution of problems.
* Assist in the transfer of technology from Process Development to GMP Manufacturing.
* Assist with technical and compliance investigations, inspections and audits.
* Report all unsafe activities to department manager, EHS and/or Human Resources.
* Participate in proactive team efforts to achieve departmental and company goals.
* Manage direct reports and escalate issues to manager as needed.
* Perform other duties as assigned.
Minimum Qualifications:
* Bachelor's degree in biology, biotechnology, chemical engineering or related field plus 3 - 5 years' cGMP upstream experience or equivalent combination of experience and education.
* A minimum of 3 years of supervisory experience specifically in upstream processing is required. The ideal candidate will be a self-driven leader with a proven track record of building strong and efficient floor operations.
Position Type/Expected Hours of Work:
This role is a full-time position with a Sunday through Wednesday schedule, working 10 hours each day (4 days x 10 hours), with operating hours from 7:00am to 6:00pm. During the initial training period, working days and hours will be Monday through Friday from 7:00am to 4:00pm.
Compensation:
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $ $75,000 - $95,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are:
* You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
* Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
* You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
* You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
Auto-ApplySupervisor, Manufacturing Downstream (Flex)
Tustin, CA jobs
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.
Your Role:
The Supervisor, Manufacturing Downstream is responsible for the supervision of Downstream manufacturing staff and operations as well as regularly performing hands-on operational activities. This includes ensuring that production is maintained in full cGMP compliance through on the floor observation, direction, and participation.
* Schedule, plan and coordinate production activities.
* Perform purification operations (column chromatography, nano-filtration, tangential flow filtration, aseptic bulk fills, etc.) on the production floor, as required.
* cGMP documentation.
* Revise initiate and review Batch Production Records (BPRs), Standard Operating Procedures (SOPs), forms and Batch History Records (BHRs).
* Identify, escalate, and write deviation reports (IRs/DRs/CAPAs). Follow through on corrective and preventative actions to ensure cGMP compliance.
* Manage the development of SOPs to ensure all manufacturing operations comply with internal and external regulatory agencies.
* Coordinate manufacturing, validation, and maintenance activities with supporting departments.
* Oversee the setup of new manufacturing processes and critical equipment.
* Identify the technical, procedural and equipment issues that hinder production and compliance.
* Communicate with team members, supervisor and members of other departments, as appropriate, to assure prompt resolution of problems.
* Assist in the transfer of technology from Process Development to GMP Manufacturing.
* Assist with technical and compliance investigations, inspections and audits.
* Report all unsafe activities to department manager, EHS and/or Human Resources.
* Participate in proactive team efforts to achieve departmental and company goals.
* Manage direct reports and escalate issues to manager as needed.
* Perform other duties as assigned
Minimum Qualifications:
* Bachelor's degree in biology, Biotechnology, Chemical Engineering or related field plus 3 - 5 years' cGMP purification experience or equivalent combination of experience and education.
* A minimum of 3 years of supervisory experience specifically in downstream processing is required. The ideal candidate will be a self-driven leader with a proven track record of building strong and efficient floor operations.
Preferred Qualifications:
* Bachelor's degree in life sciences or related field.
Position Type/Expected Hours of Work:
This role is a full-time position with a Sunday through Wednesday or a Wednesday through Saturday schedule, working 10 hours each day (4 days x 10 hours), with operating hours from 5:00pm to 4:00am. During the initial training period, working days and hours will be Monday through Friday 7:00am to 4:00pm.
Compensation:
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is $75,000 - $95,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are:
* You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
* Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
* You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
* You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
Auto-ApplySupervisor, Manufacturing Upstream
Tustin, CA jobs
Description Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: The Supervisor, Manufacturing Upstream is responsible for the supervision of Upstream manufacturing staff and operations as well as regularly performing hands on operational activities. This includes ensuring that production is maintained in full cGMP compliance through on the floor observation, direction, and participation.
Schedule, plan and coordinate production activities.
Perform cell culture and bioreactor operations from thaw through TFF on the production floor, as required.
Responding to process alarms by arriving on-site during non-business hours
cGMP documentation.
Revise initiate and review Batch Production Records (BPRs), Standard Operating Procedures (SOPs), forms and Batch History Records (BHRs).
Identify, escalate, and write deviation reports (IRs/DRs/CAPAs). Follow through on corrective and preventative actions to ensure cGMP compliance.
Manage the development of SOPs to ensure all manufacturing operations comply with internal and external regulatory agencies.
Coordinate manufacturing, validation, and maintenance activities with supporting departments.
Oversee the setup of new manufacturing processes and critical equipment.
Identify the technical, procedural and equipment issues that hinder production and compliance.
Communicate with team members, supervisor and members of other departments, as appropriate, to assure prompt resolution of problems.
Assist in the transfer of technology from Process Development to GMP Manufacturing.
Assist with technical and compliance investigations, inspections and audits.
Report all unsafe activities to department manager, EHS and/or Human Resources.
Participate in proactive team efforts to achieve departmental and company goals.
Manage direct reports and escalate issues to manager as needed.
Perform other duties as assigned.
Minimum Qualifications:
Bachelor's degree in biology, biotechnology, chemical engineering or related field plus 3 - 5 years' cGMP upstream experience or equivalent combination of experience and education.
A minimum of 3 years of supervisory experience specifically in upstream processing is required. The ideal candidate will be a self-driven leader with a proven track record of building strong and efficient floor operations.
Position Type/Expected Hours of Work: This role is a full-time position with a Sunday through Wednesday schedule, working 10 hours each day (4 days x 10 hours), with operating hours from 7:00am to 6:00pm. During the initial training period, working days and hours will be Monday through Friday from 7:00am to 4:00pm.Compensation: We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off. The compensation range for this role is $ $75,000 - $95,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment. Who you are:
You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment: In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
Auto-ApplySupervisor, Manufacturing Downstream
Tustin, CA jobs
Description Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: The Supervisor, Manufacturing Downstream is responsible for the supervision of Downstream manufacturing staff and operations as well as regularly performing hands-on operational activities. This includes ensuring that production is maintained in full cGMP compliance through on the floor observation, direction, and participation.
Schedule, plan and coordinate production activities.
Perform purification operations (column chromatography, nano-filtration, tangential flow filtration, aseptic bulk fills, etc.) on the production floor, as required.
cGMP documentation.
Revise initiate and review Batch Production Records (BPRs), Standard Operating Procedures (SOPs), forms and Batch History Records (BHRs).
Identify, escalate, and write deviation reports (IRs/DRs/CAPAs). Follow through on corrective and preventative actions to ensure cGMP compliance.
Manage the development of SOPs to ensure all manufacturing operations comply with internal and external regulatory agencies.
Coordinate manufacturing, validation, and maintenance activities with supporting departments.
Oversee the setup of new manufacturing processes and critical equipment.
Identify the technical, procedural and equipment issues that hinder production and compliance.
Communicate with team members, supervisor and members of other departments, as appropriate, to assure prompt resolution of problems.
Assist in the transfer of technology from Process Development to GMP Manufacturing.
Assist with technical and compliance investigations, inspections and audits.
Report all unsafe activities to department manager, EHS and/or Human Resources.
Participate in proactive team efforts to achieve departmental and company goals.
Manage direct reports and escalate issues to manager as needed.
Perform other duties as assigned
Minimum Qualifications:
Bachelor's degree in biology, Biotechnology, Chemical Engineering or related field plus 3 - 5 years' cGMP purification experience or equivalent combination of experience and education.
A minimum of 3 years of supervisory experience specifically in downstream processing is required. The ideal candidate will be a self-driven leader with a proven track record of building strong and efficient floor operations.
Preferred Qualifications:
Bachelor's degree in life sciences or related field.
Position Type/Expected Hours of Work:This role is a full-time position with a Monday through Friday schedule, working 8 hours each day (5 x 8 hours), with operating hours from 8:00am to 5:00pm. The employee must also, if instructed, have the ability to work overtime, weekends and/or holidays when necessary.Compensation: We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off. The compensation range for this role is $75,000 - $95,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment. Who you are:
You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment: In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
Auto-ApplySupervisor, Manufacturing Downstream (Flex)
Tustin, CA jobs
Description Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: The Supervisor, Manufacturing Downstream is responsible for the supervision of Downstream manufacturing staff and operations as well as regularly performing hands-on operational activities. This includes ensuring that production is maintained in full cGMP compliance through on the floor observation, direction, and participation.
Schedule, plan and coordinate production activities.
Perform purification operations (column chromatography, nano-filtration, tangential flow filtration, aseptic bulk fills, etc.) on the production floor, as required.
cGMP documentation.
Revise initiate and review Batch Production Records (BPRs), Standard Operating Procedures (SOPs), forms and Batch History Records (BHRs).
Identify, escalate, and write deviation reports (IRs/DRs/CAPAs). Follow through on corrective and preventative actions to ensure cGMP compliance.
Manage the development of SOPs to ensure all manufacturing operations comply with internal and external regulatory agencies.
Coordinate manufacturing, validation, and maintenance activities with supporting departments.
Oversee the setup of new manufacturing processes and critical equipment.
Identify the technical, procedural and equipment issues that hinder production and compliance.
Communicate with team members, supervisor and members of other departments, as appropriate, to assure prompt resolution of problems.
Assist in the transfer of technology from Process Development to GMP Manufacturing.
Assist with technical and compliance investigations, inspections and audits.
Report all unsafe activities to department manager, EHS and/or Human Resources.
Participate in proactive team efforts to achieve departmental and company goals.
Manage direct reports and escalate issues to manager as needed.
Perform other duties as assigned
Minimum Qualifications:
Bachelor's degree in biology, Biotechnology, Chemical Engineering or related field plus 3 - 5 years' cGMP purification experience or equivalent combination of experience and education.
A minimum of 3 years of supervisory experience specifically in downstream processing is required. The ideal candidate will be a self-driven leader with a proven track record of building strong and efficient floor operations.
Preferred Qualifications:
Bachelor's degree in life sciences or related field.
Position Type/Expected Hours of Work:This role is a full-time position with a Sunday through Wednesday or a Wednesday through Saturday schedule, working 10 hours each day (4 days x 10 hours), with operating hours from 5:00pm to 4:00am. During the initial training period, working days and hours will be Monday through Friday 7:00am to 4:00pm. Compensation: We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off. The compensation range for this role is $75,000 - $95,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment. Who you are:
You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment: In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 20 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
Auto-ApplyManufacturing Formulation Supervisor 3rd shift
Lee, MA jobs
The Formulation Supervisor is a working supervisor role responsible for all aspects of formulation activities to ensure achievement of the production and quality goals set by management as well as providing support and direction to formulation personnel.
Duties and Responsibilities
Oversee and participate in daily formulation activities and ensure all scheduled tasks/events are completed
Responsible for lab setup and process flows, in-process testing, API dissolution and final QS while ensuring safety, batch integrity and prevention or errors that could lead to product and or financial loss
Maintain weekly/daily schedule
Use production schedule and activities, communicate necessary to do tasks to associates and/or leads
Communicate and maintain the thaw / equilibration schedules for chemicals and/or equipment
Maintain an adequate supply of formulation supplies so as not to impact the production schedule, follow replenishing process as needed
Review Master Production Batch records in timely manner and provides suggestions/corrections to PE member
Review SOPs accurately for communicating and initiate the documentation change process (DCR/MOC) for needed documentation changes within established timeframes
Complete executed Batch Records accurately and complete manufacturing review within established timeframes prior to submission to QA for review
Initiate process deviations as they occur within the department, participate in investigations, and contribute to identifying corrective and preventative actions
Identify safety risks and alerts management to take corrective action
Provide timely communication to management and clients of issues, challenges as well as opportunities for process improvements
Other duties as assigned
Regulatory Responsibilities
Ensure all work is conducted following a high standard of GMP compliance and written SOP and batch records
Comply with all area SOPs and ensure logbooks are completed and adhere to cGMP requirements
Supervisory Responsibilities
Assign and direct work, provide direction, resources and resolve problems
Participate in recruiting
Provide feedback on performance to Formulation Manager
Train team members and ensures proper training is completed prior to assigning tasks
Experience
Familiar with cGMP regulations and principles and how to apply them to the manufacturing of pharmaceutical/biotech products
Two (2) to three (3) years' work experience in formulation within a GMP environment preferably in fill finish pharmaceutical operations or proven ability of same
Leadership experience as a team lead of supervisor type role preferred
Education
Bachelor's degree preferred
An equivalent combination of education and experience may be considered
Knowledge, Skills & Abilities
Possess working knowledge of formulation/compounding processes and equipment
cGMP and cGLP practices
Experience with Microsoft Office and general computer proficiency
Attention to detail
Able to follow rules and regulations
Mechanical aptitude
Resilient, can quickly move forward despite challenges, thrives on challenges to improve skills and abilities
Honesty, integrity, respect and courtesy with leadership and peers
Ability to build collaborative relationships
Supervisory skills
Conflict resolution
Able to perform complex work instructions and trouble shoot complex problems
Physical Requirements
Able to meet gowning requirements
Visual acuity
Fine and gross motor skills to manipulate tools and equipment
Able to remain stationary for continuous prolonged periods of time
Able to lift 30lbs repeatedly
Able to wear PPE
Able to be medically qualified to participate in respirator program
Able to use standard office equipment with or without reasonable accommodation
Auto-ApplyManufacturing Formulation Supervisor 3rd shift
Lee, MA jobs
The Formulation Supervisor is a working supervisor role responsible for all aspects of formulation activities to ensure achievement of the production and quality goals set by management as well as providing support and direction to formulation personnel.
Duties and Responsibilities
Oversee and participate in daily formulation activities and ensure all scheduled tasks/events are completed
Responsible for lab setup and process flows, in-process testing, API dissolution and final QS while ensuring safety, batch integrity and prevention or errors that could lead to product and or financial loss
Maintain weekly/daily schedule
Use production schedule and activities, communicate necessary to do tasks to associates and/or leads
Communicate and maintain the thaw / equilibration schedules for chemicals and/or equipment
Maintain an adequate supply of formulation supplies so as not to impact the production schedule, follow replenishing process as needed
Review Master Production Batch records in timely manner and provides suggestions/corrections to PE member
Review SOPs accurately for communicating and initiate the documentation change process (DCR/MOC) for needed documentation changes within established timeframes
Complete executed Batch Records accurately and complete manufacturing review within established timeframes prior to submission to QA for review
Initiate process deviations as they occur within the department, participate in investigations, and contribute to identifying corrective and preventative actions
Identify safety risks and alerts management to take corrective action
Provide timely communication to management and clients of issues, challenges as well as opportunities for process improvements
Other duties as assigned
Regulatory Responsibilities
Ensure all work is conducted following a high standard of GMP compliance and written SOP and batch records
Comply with all area SOPs and ensure logbooks are completed and adhere to cGMP requirements
Supervisory Responsibilities
Assign and direct work, provide direction, resources and resolve problems
Participate in recruiting
Provide feedback on performance to Formulation Manager
Train team members and ensures proper training is completed prior to assigning tasks
Experience
Familiar with cGMP regulations and principles and how to apply them to the manufacturing of pharmaceutical/biotech products
Two (2) to three (3) years' work experience in formulation within a GMP environment preferably in fill finish pharmaceutical operations or proven ability of same
Leadership experience as a team lead of supervisor type role preferred
Education
Bachelor's degree preferred
An equivalent combination of education and experience may be considered
Knowledge, Skills & Abilities
Possess working knowledge of formulation/compounding processes and equipment
cGMP and cGLP practices
Experience with Microsoft Office and general computer proficiency
Attention to detail
Able to follow rules and regulations
Mechanical aptitude
Resilient, can quickly move forward despite challenges, thrives on challenges to improve skills and abilities
Honesty, integrity, respect and courtesy with leadership and peers
Ability to build collaborative relationships
Supervisory skills
Conflict resolution
Able to perform complex work instructions and trouble shoot complex problems
Physical Requirements
Able to meet gowning requirements
Visual acuity
Fine and gross motor skills to manipulate tools and equipment
Able to remain stationary for continuous prolonged periods of time
Able to lift 30lbs repeatedly
Able to wear PPE
Able to be medically qualified to participate in respirator program
Able to use standard office equipment with or without reasonable accommodation
Auto-Apply