Manufacturing Technician jobs at Krystal Biotech - 50 jobs
Manufacturing Support Technician
Krystal Biotech 4.0
Manufacturing technician job at Krystal Biotech
About Krystal Bio: At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs.
Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient's end-to-end experience.
Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK , for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology.
Krystal is headquartered in Pittsburgh, PA, which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity. As we grow, we are seeking team members that embody these values.
Job Description Summary:
Krystal Biotech, Inc is seeking a highly motivated Manufacturing Support Technician to support our commercial manufacturing facility in the South Side. The Technician will work closely with the manufacturing team to uphold cleanroom standards, follow strict procedures, and contribute to the smooth operation of all manufacturing processes.
Primary Responsibilities:
Assist in the setup, breakdown, and cleaning of equipment and manufacturing areas before and after production runs
Collaborate with manufacturing and quality teams to ensure that facilities are prepared and ready for production activities as per schedule
Execute and maintain strict cleaning and sanitization protocols in compliance with current Good Manufacturing Practices (cGMP) guidelines and Standard Operating Procedures (SOPs)
Conduct routine inspections of cleanrooms to identify any cleanliness or contamination issues, promptly reporting and addressing them according to established procedures
Follow and document all procedures, including batch records, cleaning logs, and any other required documentation accurately and in a timely manner
Adhere to safety protocols and guidelines, including proper handling and disposal of hazardous waste materials
Support the maintenance of process gas levels, calibration of equipment, and preventative maintenance schedules
Participate in training sessions and meetings to stay updated on the latest industry standards, regulations, and best practices
Assist with movement of materials; work with EHS/Materials Teams for collection and dispensing of biohazardous waste
Support a standard 40-hour work week with flexibility to support occasional off-shift hours and/or weekends
Perform other tasks, as assigned
Requirements and Preferred Qualifications:
High school diploma or equivalent is required; additional technical or vocational training in biopharma manufacturing, cleanroom operations, or related fields is a plus
In lieu of direct experience, bachelor's degrees in applicable fields such as life sciences or engineering will be considered
Experience with sanitization, aseptic technique and/or sterile processes in a regulated setting (GMP, ISO) is highly preferred
Ability to follow detailed instructions and maintain accurate documentation
Excellent attention to detail, organization skills, and the ability to prioritize and multitask effectively in a fast-paced environment
Demonstrated commitment to safety protocols and adherence to standard operating procedures
Excellent communication and the ability to work well both independently and as part of a team
Physical stamina and the ability to stand, bend, and lift heavy objects when necessary
Flexibility to work shifts, including evenings, weekends, and holidays as required.
Krystal Biotech, Inc. is an Equal Employment Opportunity and Affirmative Action Employers. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter and agency resumes. Krystal Biotech, Inc. will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc.
$29k-42k yearly est. Auto-Apply 60d+ ago
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2026 Future Talent Program - Vaccine Manufacturing Co-op
MSD 4.6
Point, PA jobs
The Future Talent Program features co-operative assignments that last up to 6 months and will include one or more projects. These opportunities in our Manufacturing & Supply Division can provide you with great development and a chance to see if we are the right company for your long-term goals.
This position will report to vaccine production or engineering management and support ongoing operational activities. Given the close interaction with actual Good Manufacturing Practice manufacturing, candidates need to be prepared to comply with Good Manufacturing Practice gowning restrictions for some of their activities (e.g. remove jewelry, remove make-up, remove false nails, etc.).
This position is responsible for but not limited to:
Providing on-the-floor support of operational and technical issues; collaborating with the shop floor on a variety of different projects and activities that are critical to ongoing manufacturing of vaccines at the West Point, PA site.
Performing deviation investigations aimed to prevent deviation re-occurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment. Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc.
Completing projects to improve the performance of our processes and manufacturing performance, including projects aimed at improving Right-First-Time performance or preventing/reducing deviations, and continuous improvement projects that seek to improve yield, reduce cost, or lower our processing cycle times.
Supporting team safety, environmental and compliance objectives.
Collaboration with the area Managers, Operators/Mechanics, support groups (Maintenance, Automation, Technology, Quality, and Supply Chain).
Executing projects and assigned studies in a right-first-time manner.
Actively using and championing the use of Lean Six Sigma (LSS) tools, both in problem solving and day-to-day operational activities.
Provide progress updates to mentor summarizing the status of the assignments that are underway.
Work with assigned mentor to develop personal and professional skills.
This is a full-time Co-Op position.
Required Education & Experience:
Candidate must be pursuing an Associates, BS, or MS degree in Chemical, Mechanical, Biomedical, or related Engineering discipline, or pursuing an Associates, BS, or MS degree in Chemistry, Biology, Biotechnology, Microbiology, Virology, or Business and Engineering.
Candidates must have communication, leadership and teamwork skills.
Preferred Experience & Skills:
Candidates should have experience in biologics, vaccine or bulk sterile manufacturing facilities.
Candidates should have experience using Lean/Six Sigma tools.
Candidates should have capabilities for managing multiple tasks simultaneously, including leading small projects.
Candidates should have experience in problem solving and/or troubleshooting.
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.
Please note that this position may be closed before the posted end date or may remain open longer, at the discretion of the company.
Salary range:
The salary range for this role is $39,600.00-$105,500.00 USD
MD2026
FTP2026
#WE25
#SHPE2025
#NDiSTEM
Required Skills:
Biopharmaceuticals, Deviation Investigations, Global Manufacturing, Good Manufacturing Practices (GMP), Hiring, Immunochemistry, Lean Six Sigma (LSS), Logistics, Mechatronics, Microbiology, Pharmaceutical Biology, Preventive Action, Procurement, Production Operations, Project Management Engineering
Preferred Skills:
Automation Engineering, Automation Engineering, Biology, Biomedical Engineering, Chemical Engineering, Chemistry, Collaboration Tools, Communication, Computer Networking, Cost Modeling, Cost Reduction, Creativity, Empathy, Environmental Regulatory Compliance, Equipment Maintenance, Group Problem Solving, Impact Evaluation, Leadership, Lean Manufacturing, Logistics Operations, Maintenance Management, Makeup Art, Manufacturing, Manufacturing Engineering, Mechanical Engineering {+ 14 more}
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, 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. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Intern/Co-op (Fixed Term)
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
01/31/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
$31k-38k yearly est. Auto-Apply 60d+ ago
2027 Future Talent Program - Packaging Technology Co-op
MSD 4.6
Point, PA jobs
The Future Talent Program features Cooperative (Co-op) education that lasts up to 6 months and will include one or more projects. These opportunities in our Manufacturing & Supply Division can provide you with great development and a chance to see if we are the right company for your long-term goals.
The co-op assignment will support our Manufacturing Division's Packaging Technology Community's three unique groups. These groups serve as our company's central packaging Centers of Excellence with global responsibility for packaging related activities. The position is based in West Point, PA (a suburb of Philadelphia).
The candidate selected will have opportunities to gain hands-on experience in a wide variety of areas within pharmaceutical packaging. Examples include:
Primary and secondary packaging development and testing for solid oral dose, sterile and medical device products
Packaging equipment development and qualification
Packaging processes and controls
Bulk packaging development and testing
Distribution packaging development and testing
Thermal packaging development and testing
Packaging related documentation and regulations
Customer focus and usability testing
These activities will provide the co-op with exposure to other departments, cross functional teams, suppliers, etc. Travel to company and contract packaging sites, equipment and component manufacturers and/or testing facilities is expected as part of the hands-on experience.
Required Education and Experience:
Candidate must be currently pursuing degree in Packaging Science, Packaging Engineering, Mechanical Engineering, or related discipline
Candidate must be currently enrolled in an academic program and returning to university following this co-op assignment to complete credit requirements for graduation
Candidate must be available for full-time employment for a period of 6 months in Jan-Jun 2027
Preferred Experience and Skills:
Candidate should have strong project management, problem solving, organizational, technical writing and communication skills
Candidate should have a GPA of 3.0 or higher
Please note that this position may be closed before the posted end date or may remain open longer, at the discretion of the company.
Salary range:
The salary range for this role is $39,600.00-$105,500.00 USD
Required Skills:
Accountability, Accountability, Clinical Research, Cloud Data Catalog, Communication, Data Analysis, Database Management, Data Science, Data Security, Data Visualization, Data Wrangling, Detail-Oriented, Event Planning, Key Performance Indicators (KPI), Mechanical Engineering, Mechatronics, Medical Device Management, Microsoft Office, Packaging Engineering, Packaging Management, Packaging Optimization, Packaging Processes, Packaging Research, Pharmaceutical Packaging, Product Packaging Design {+ 5 more}
Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, 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. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Intern/Co-op (Fixed Term)
Relocation:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
05/8/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
The Future Talent Program features Cooperative (Co-op) education that lasts up to 6 months and will include one or more projects. These opportunities in our Research Division can provide you with great development and a chance to see if we are the right company for your long-term goals.
Our Research Scientists and Engineers are our inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities, and robust scientific methodology we collaborate to discover the next medical breakthrough.
We are seeking candidates for a Co-Op opportunity in our company's Vaccines and Advanced Biotechnologies Process R&D division. Specifically, this candidate would work within West Point's Biologics Pilot Plant (BPP) GMP clinical manufacturing facility. Under the direction of a project mentor, a successful candidate may work on initiatives within either the automation, process operations, or capital sub-team in the BCMT (Bioprocess Clinical Manufacturing and Technology) department.
Example Projects/Day to Day Work:
Automation: Develop code for process control, monitoring, and visualization. Develop tools to increase efficiency in the automation group and the BCMT department as a whole. Day-to-day work might include writing code, working on GMP change controls and documentation, and equipment/system testing.
Process Operations: Knowledge Management overhaul: review and clean-up SharePoint, implement playbooks for new ways of working, update templates for key deliverables. New equipment qualification support. Day-to-day work might include attending team meetings, GMP manufacturing support, equipment testing, and document generation.
Capital: Equipment specification, installation, testing, and qualification. Day-to-day work may include document generation and field execution of equipment commissioning and qualification.
The successful candidate will be expected to demonstrate the ability to convey the results of their work in both verbal and written formats. In addition to the core duties outlined above, the candidate will be expected to comply with all required training and Quality systems, collaborate across multiple functional teams, and maintain focused attention on safety for themselves and their team.
Education Minimum Requirement:
Candidates must be enrolled in a minimum of a BS/BA in: Engineering, Computer Science, Data Science, Chemistry, Biology, or other relevant discipline.
Required Experience and Skills:
Must have the ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
Must have ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
Effective organization, interpersonal, verbal and written communication skills.
Candidates must be available to work full-time for 4-6 months.
Preferred Experience and Skills by Group:
Automation: Programming experience especially python and/or process control (PLC, DeltaV, etc.). Previous GMP, manufacturing, and/or equipment experience. A drive to self-learn technologies with initial guidance.
Process Operations: Proven ability to work in hands-on laboratory or manufacturing setting. Direct experience with cell culture/fermentation and/or downstream purification operations of large molecules (vaccines or biologics).
Capital: Previous GMP, manufacturing, and/or equipment experience. Engineering degree preferred.
To learn more about the PRD team, click: Join Our Process Research & Development Team
Please note that this position may be closed before the posted end date or may remain open longer, at the discretion of the company.
Salary range:
The salary range for this role is $39,600.00-$105,500.00 USD
FTP2026
RL2026
PRD
Required Skills:
Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, 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. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Intern/Co-op (Fixed Term)
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
02/12/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
The Future Talent Program features Cooperative (Co-op) education that lasts up to 6 months and will include one or more projects. These opportunities in our Research Division can provide you with great development and a chance to see if we are the right company for your long-term goals.
Our Research Scientists and Engineers are our inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities, and robust scientific methodology we collaborate to discover the next medical breakthrough.
We are seeking candidates for a Co-Op opportunity in our company's Vaccines and Advanced Biotechnologies Process R&D division. Specifically, this candidate would work within West Point's Biologics Pilot Plant (BPP) GMP clinical manufacturing facility. Under the direction of a project mentor, a successful candidate may work on initiatives within either the automation, process operations, or capital sub-team in the BCMT (Bioprocess Clinical Manufacturing and Technology) department.
Example Projects/Day to Day Work:
Automation: Develop code for process control, monitoring, and visualization. Develop tools to increase efficiency in the automation group and the BCMT department as a whole. Day-to-day work might include writing code, working on GMP change controls and documentation, and equipment/system testing.
Process Operations: Knowledge Management overhaul: review and clean-up SharePoint, implement playbooks for new ways of working, update templates for key deliverables. New equipment qualification support. Day-to-day work might include attending team meetings, GMP manufacturing support, equipment testing, and document generation.
Capital: Equipment specification, installation, testing, and qualification. Day-to-day work may include document generation and field execution of equipment commissioning and qualification.
The successful candidate will be expected to demonstrate the ability to convey the results of their work in both verbal and written formats. In addition to the core duties outlined above, the candidate will be expected to comply with all required training and Quality systems, collaborate across multiple functional teams, and maintain focused attention on safety for themselves and their team.
Education Minimum Requirement:
Candidates must be enrolled in a minimum of a BS/BA in: Engineering, Computer Science, Data Science, Chemistry, Biology, or other relevant discipline.
Required Experience and Skills:
Must have the ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
Must have ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
Effective organization, interpersonal, verbal and written communication skills.
Candidates must be available to work full-time for 4-6 months.
Preferred Experience and Skills by Group:
Automation: Programming experience especially python and/or process control (PLC, DeltaV, etc.). Previous GMP, manufacturing, and/or equipment experience. A drive to self-learn technologies with initial guidance.
Process Operations: Proven ability to work in hands-on laboratory or manufacturing setting. Direct experience with cell culture/fermentation and/or downstream purification operations of large molecules (vaccines or biologics).
Capital: Previous GMP, manufacturing, and/or equipment experience. Engineering degree preferred.
To learn more about the PRD team, click: Join Our Process Research & Development Team
Please note that this position may be closed before the posted end date or may remain open longer, at the discretion of the company.
Salary range:
The salary range for this role is $39,600.00-$105,500.00 USD
FTP2026
RL2026
PRD
Required Skills:
Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, 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. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Intern/Co-op (Fixed Term)
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
02/12/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
$29k-45k yearly est. Auto-Apply 60d+ ago
MANUFACTURING TECHNICIAN IV
Te Connectivity 4.0
Middletown, PA jobs
**At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.** Job Description: The Manufacturing Process & Development Technician will support the establishment, maturation, and scaling of DDN's in-house laser machining capability within the Advanced Manufacturing Process (AMP) organization. This role will work hands-on alongside the technical lead to execute laser machining trials, support process development activities, and assist with prototyping of high-precision features in metals, polymers, ceramics, composites, and thin films. The technician will focus on equipment operation, data collection, setup optimization, and day-to-day execution to enable rapid iteration and reliable process outcomes.
**Job Requirements**
This first shift role supports a newly established laser machining lab where priorities, processes, and focus areas will continue to evolve as the capability matures. Candidates must be able to adapt quickly to rapid engineering changes during prototype development such as program priorities, technical objectives, and customer requirements shift. Success in this role also requires an open-minded approach, strong listening skills, and a willingness to consider and incorporate diverse perspectives when processing prototype samples and supporting cross-functional initiatives.
- Set up, program, operate, and monitor laser machining equipment for cutting, drilling, ablation, and trimming.
- Hands-on execution of laser system optimization, fixture setup, material loading, and process parameter setup under the guidance of the technical lead.
- Support experimental runs and DOE activities by preparing samples, running trials, and recording process parameters and results.
- Perform basic inspection and measurement of machined features using microscopes and metrology tools.
- Document experimental data, observations, and process outcomes in standardized logs.
- Conduct routine equipment checks, preventative maintenance tasks, and troubleshooting to support up time.
- Handle materials, tooling, and consumables in accordance with lab procedures and safety requirements.
- Follow and reinforce laser safety practices, interlocks, and lab protocols.
- Collaborate with engineers and team members to support rapid prototyping and iterative development activities.
- Support innovation and continuous improvement by learning emerging laser technologies and applications through vendor training, workshops, and industry trade shows, and sharing insights with the AMP team.
- Strong mindset for innovation and a willingness to take initiative by proactively identifying opportunities, suggesting improvements, and stepping in to support tasks as needed.
**What your background should look like**
**Required** :
- High School Diploma or GED.
- 4 years or more of related work experience.
- Demonstrated solid mechanical aptitude and hands-on skills.
- Basic understanding of manufacturing technologies such as stamping, plating, molding, and component assembly.
- Strong understanding and application of GD&T principles.
- Hands-on experience with a variety of machining methods, including CNC milling, wire EDM, and manual milling operations.
- Proficiency in Microsoft Office for documentation and reporting.
- Strong organizational and interpersonal skills.
**Preferred** :
- Associate degree in Mechanical Engineering Technology, Manufacturing Technology, Precision Machining, or a related field, or completion of a metalworking apprenticeship or trade school with relevant experience.
- Experience or hands-on exposure to precision laser machining, (including infrared (IR) and femtosecond laser systems), for producing high-accuracy micro-features and tight-tolerance components.
- Metal working trade with demonstrated success working with engineer's sketches, rough drawings, as well as formal drawings.
- Proficiency in CAD modeling software, including Creo, SpaceClaim, SolidWorks, and other general 3D design tools.
- Familiarity with manufacturing environments involving Stamping, Plating, Assembly and Molding (SPAM) technologies for precision components is preferred.
**Travel Requirement**
Occasional travel may be required for training, vendor workshops, or collaboration with other TE Connectivity facilities. Estimated travel: up to 10%.
**Competencies**
Values: Integrity, Accountability, Inclusion, Innovation, Teamwork
**ABOUT TE CONNECTIVITY**
TE Connectivity plc (NYSE: TEL) is a global industrial technology leader creating a safer, sustainable, productive, and connected future. As a trusted innovation partner, our broad range of connectivity and sensor solutions enable the distribution of power, signal and data to advance next-generation transportation, energy networks, automated factories, data centers enabling artificial intelligence, and more.
Our more than 90,000 employees, including 10,000 engineers, work alongside customers in approximately 130 countries. In a world that is racing ahead, TE ensures that EVERY CONNECTION COUNTS. Learn more at ********** and on LinkedIn (************************************************** ,Facebook (***************************************** ,WeChat, (http://**********.cn/chn-zh/policies-agreements/wechat.html) Instagram andX (formerly Twitter). (***********************************
**COMPENSATION**
- Competitive base salary commensurate with experience: $68,400 - $102,600 (subject to change dependent on physical location)
- Posted salary ranges are made in good faith. TE Connectivity reserves the right to adjust ranges depending on the experience/qualification of the selected candidate as well as internal and external equity.
- Total Compensation = Base Salary + Incentive(s) + Benefits
**BENEFITS**
- A comprehensive benefits package including health insurance, 401(k), disability, life insurance, employee stock purchase plan, paid time off and voluntary benefits.
**EOE, Including Disability/Vets**
**IMPORTANT NOTICE REGARDING RECRUITMENT FRAUD**
TE Connectivity has become aware of fraudulent recruitment activities being conducted by individuals or organizations falsely claiming to represent TE Connectivity. Please be advised that TE Connectivity **never requests payment or fees** from job applicants at any stage of the recruitment process. All legitimate job openings are posted exclusively on our official careers website at te.com/careers, and all email communications from our recruitment team will come **only from actual email addresses ending ************ . If you receive any suspicious communications, we strongly advise you not to engage or provide any personal information, and to report the incident to your local authorities.
**Job Locations:**
Posting City: MIDDLETOWN
Job Country: United States
Travel Required: 10% to 25%
Requisition ID: 144908
Workplace Type:
External Careers Page: Engineering & Technology
TE Connectivity and its subsidiaries, affiliates, and operating units (collectively, the "Company") is committed to providing a work environment that prohibits discrimination on the basis of age, color, disability, ethnicity, marital status, national origin, race, religion, gender, gender identity, sexual orientation, protected veteran status, disability or any other characteristics protected by applicable law or regulation.
$29k-46k yearly est. 44d ago
Technician Manufacturing (Mechanical Device) 2nd shift-Exton, PA
DSM 4.3
Exton, PA jobs
TechnicianManufacturing, (Mechanical Device) 2nd shift Exton, PA (USA) Onsite (Monday - Friday 2:00 PM - 10:30 PM) As a ManufacturingTechnician in Mechanical Device, you will assure that dsm-firmenich products are of consistent and high quality by producing products in compliance with established DSM/GMP procedures. It is helpful if you can work with small parts and tie knots for our mechanical devices. dsm-firmenich Biomedical is the world's unrivaled biomaterials expert and committed partner in driving sustainable innovation in healthcare.
Responsibilities:
* Assists with performing designated operations within the manufacturing department, non-controlled and controlled environment in accordance with dsm-firmenich Standard Operation Procedures and all safety requirements as assigned.
* Handling of chemicals and solvents may be required.
* Provide basic support to outside own department as needed.
* Provides suggestions on potential improvement opportunities in quality, product, processes and efficiency.
* Addresses simple and recognizable problems, from past experiences, and chooses from established alternative approaches to find a solution.
We bring:
* Paid holidays, 18 days PTO + 2 floating holidays.
* Full healthcare benefits day one - medical, dental, eye and life insurance.
* 401K with generous company match.
* A competitive compensation package, with comprehensive health and welfare benefits.
* A place to grow and develop.
* A company that is purpose-led and performance-driven in a corporate culture that values people and planet.
* The opportunity to work on growing brands and build on a strong foundation.
* The chance to make improvements and make an impact on the business.
You bring:
* High School Diploma/GED. wo-year technical degree preferred or equivalent years of experience in related fields.
* 0-5 years' experience, preferably in Medical Device manufacturing or GMP related industry.
* Ability to work with small parts and tie knots.
* Strong oral and written communication skills.
* Proficient in the use of M/S Office, Word, and Excel.
* Knowledge and experience working with machinery, tooling, and products/processes in a medical device environment preferred.
* Industrial scale hands-on experience with process optimization focus.
The salary or hourly wage scale provided reflects the pay range dsm-firmenich expects to pay the successful candidate for the position. Individual pay offered will be based on the applicant's job-related skills, experience, relevant education, or training, and primary work location. Hourly $23.00 + $1.25/hour 2nd shift differntial USD.
In addition to base salary, we also offer a comprehensive total rewards package, inclusive of annual incentive pay, a retirement savings plan, health care coverage, paid time off, recognition programs and a broad range of other benefits. All benefits and incentives are subject to eligibility requirements.
About dsm-firmenich
At dsm-firmenich, we don't just meet expectations - we go beyond them.
Join our global team powered by science, creativity, and a shared purpose: to bring progress to life.
From elevating health to making fortified food and sustainable skincare, the impact of your work here will be felt by millions - every single day. Whether it's fragrance that helps you focus, alternative meat that's better for the planet, or reducing sugar without losing flavor, this is where you help shape the future of nutrition, health, and beauty for everyone, everywhere.
And while you're making a difference, we'll make sure you're growing too. With learning that never stops, a culture that lifts you up and the freedom to move across businesses, teams, and borders. Your voice matters here. And your ideas? They're essential to our future.
Because real progress only happens when we go beyond, together.
Inclusion, belonging and equal opportunity statement
At dsm-firmenich, we believe being a force for good starts with the way we treat each other. When people feel supported, included, and free to be themselves, they do their best work - and that's exactly the kind of culture we're building. A place where opportunity is truly equal, authenticity is celebrated, and everyone has the chance to grow, contribute, and feel they belong.
We're proud to be an equal opportunity employer, and we're serious about making our hiring process as fair and inclusive as possible. From inclusive language and diverse interview panels to thoughtful sourcing, we're committed to reflecting the world we serve.
We welcome candidates from all backgrounds - no matter your gender, ethnicity, sexual orientation, or anything else that makes you, you.
And if you have a disability or need any support through the application process, we're here to help - just let us know what you need, and we'll do everything we can to make it work.
Agency statement
We're managing this search directly at dsm-firmenich. If you're applying as an individual, we'd love to hear from you. We're not accepting agency submissions or proposals involving fees or commissions for this role.
$23 hourly 52d ago
Technician Manufacturing (Cleanroom Packaging) 1st shift- Exton, PA
DSM 4.3
Exton, PA jobs
TechnicianManufacturing (Cleanroom Packaging), 1st shift Exton, PA Monday - Friday, 6:00am - 2:30pm As a ManufacturingTechnician in Packaging, you will assure that dsm-firmenich products are of consistent and high quality by producing products in compliance with established DSM/GMP procedures. It is helpful if you can work with small parts and tie knots for our mechanical devices.
dsm-firmenich Biomedical is the world's unrivaled biomaterials expert and committed partner in driving sustainable innovation in healthcare. For more than 30 years, the company has been at the forefront of biomaterial science and process innovation, and the leading resource for global medical device and pharmaceutical companies.
Your key responsibilities
* Assists with performing designated operations within their manufacturing department, non-controlled and controlled environment areas in accordance with dsm-firmenich Standard Operation Procedures and all safety requirements as assigned.
* Handling of chemicals and solvents may be required.
* Provides basic support to outside own department as required.
* Provides suggestions on potential improvement opportunities in quality, product, processes and efficiency.
* Addresses simple and recognizable problems, from past experiences, and chooses from established alternative approaches to find a solution.
* Works with R&D, Engineering and other dsm-firmenich groups as assigned.
* Expresses ideas and listens to ideas of others.
* Seeks opportunities and sets goals for own development. Identifies and learns from mentors/developmental advisors. Keeps appropriate people informed.
* Works within job/position specific deadlines and schedules set by production schedule/supervisor. Keep detailed, accurate, and legible paper and computerized records of production activities following dsm-firmenich/GMP guidelines.
* Advise Group Lead/and/or Supervisor of perceived problems with processes, machinery, or product quality. Perform other duties as assigned by Manufacturing Supervisor.
* Assure product quality through close attention to detail, inspection methods, and in-process testing as required.
We offer
* Paid holiday, 18 days PTO + 2 floating holidays
* Full healthcare benefits day one - medical, dental, eye, and life insurance.
* 401K with generous company match
* Unique career paths across health, nutrition and beauty - explore what drives you and get the support to make it happen
* A chance to impact millions of consumers every day - sustainability embedded in all we do
* A science led company, cutting edge research and creativity everywhere -from biotech breakthroughs to sustainability game-changers, you'll work on what's next
* Growth that keeps up with you - you join an industry leader that will develop your expertise and leadership
* A culture that lifts you up - with collaborative teams, shared wins, and people who cheer each other on
* A community where your voice matters - it is essential to serve our customers well.
You bring
* High School Diploma/GED. Two-year technical degree preferred or equivalent years of experience in related fields.
* 0-5 years' experience, preferably in Medical Device manufacturing or GMP related industry.
* Packaging experience, preferably in medical device manufacturing or related industry.
* Strong oral and written communication skills to provide information to others by telephone, in written form, email, or in person. Interpersonal skills to interact and communicate effectively with all levels of personnel.
* Proficient in the use of M/S Office, Word, and Excel.
* Ability to operate various equipment and hand tool in assigned areas with limited supervision.
* Industrial scale hands-on experience with process optimization focus. Ability to identify process improvement opportunities and present them.
The salary or hourly wage scale provided reflects the pay range dsm-firmenich expects to pay the successful candidate for the position. Individual pay offered will be based on the applicant's job-related skills, experience, relevant education, or training, and primary work location. Hourly $23.00 USD.
In addition to base salary, we also offer a comprehensive total rewards package, inclusive of annual incentive pay, a retirement savings plan, health care coverage, paid time off, recognition programs and a broad range of other benefits. All benefits and incentives are subject to eligibility requirements.
About dsm-firmenich
At dsm-firmenich, we don't just meet expectations - we go beyond them.
Join our global team powered by science, creativity, and a shared purpose: to bring progress to life.
From elevating health to making fortified food and sustainable skincare, the impact of your work here will be felt by millions - every single day. Whether it's fragrance that helps you focus, alternative meat that's better for the planet, or reducing sugar without losing flavor, this is where you help shape the future of nutrition, health, and beauty for everyone, everywhere.
And while you're making a difference, we'll make sure you're growing too. With learning that never stops, a culture that lifts you up and the freedom to move across businesses, teams, and borders. Your voice matters here. And your ideas? They're essential to our future.
Because real progress only happens when we go beyond, together.
Inclusion, belonging and equal opportunity statement
At dsm-firmenich, we believe being a force for good starts with the way we treat each other. When people feel supported, included, and free to be themselves, they do their best work - and that's exactly the kind of culture we're building. A place where opportunity is truly equal, authenticity is celebrated, and everyone has the chance to grow, contribute, and feel they belong.
We're proud to be an equal opportunity employer, and we're serious about making our hiring process as fair and inclusive as possible. From inclusive language and diverse interview panels to thoughtful sourcing, we're committed to reflecting the world we serve.
We welcome candidates from all backgrounds - no matter your gender, ethnicity, sexual orientation, or anything else that makes you, you.
And if you have a disability or need any support through the application process, we're here to help - just let us know what you need, and we'll do everything we can to make it work.
Agency statement
We're managing this search directly at dsm-firmenich. If you're applying as an individual, we'd love to hear from you. We're not accepting agency submissions or proposals involving fees or commissions for this role.
Technician, Manufacturing (Natural Materials) 1st shift Monday - Friday 6:00am - 2:30pm As a Technician, Manufacturing, (Natural Materials) you will assure that dsm-firmenich products are of consistent and high quality by producing products in compliance with established DSM/GMP procedures.
dsm-firmenich Biomedical is the world's unrivaled biomaterials expert and committed partner in driving sustainable innovation in healthcare. For more than 30 years, the company has been at the forefront of biomaterial science and process innovation, and the leading resource for global medical device and pharmaceutical companies.
Your Key Responsibilities:
* Assists with performing designated operations within their manufacturing department, non-controlled and controlled environment areas in accordance with DSM Standard Operation Procedures and all safety requirements as assigned.
* Handling of chemicals and solvents may be required.
* Provides basic support to outside own department as required.
* Provides suggestions on potential improvement opportunities in quality, product, processes and efficiency.
* Addresses simple and recognizable problems, from past experiences, and chooses from established alternative approaches to find a solution.
* Works with R&D, Engineering and other DSM groups as assigned.
* Expresses ideas and listens to ideas of others.
We offer
* Paid holiday, 18 days PTO + 2 floating holidays
* Full healthcare benefits day one - medical, dental, eye, and life insurance.
* 401K with generous company match
* Unique career paths across health, nutrition and beauty - explore what drives you and get the support to make it happen
* A chance to impact millions of consumers every day - sustainability embedded in all we do
* A science led company, cutting edge research and creativity everywhere -from biotech breakthroughs to sustainability game-changers, you'll work on what's next
* Growth that keeps up with you - you join an industry leader that will develop your expertise and leadership
* A culture that lifts you up - with collaborative teams, shared wins, and people who cheer each other on
* A community where your voice matters - it is essential to serve our customers well.
The salary or hourly wage scale provided reflects the pay range dsm-firmenich expects to pay the successful candidate for the position. Individual pay offered will be based on the applicant's job-related skills, experience, relevant education, or training, and primary work location. Hourly $23.00 USD.
In addition to base salary, we also offer a comprehensive total rewards package, inclusive of annual incentive pay, a retirement savings plan, health care coverage, paid time off, recognition programs and a broad range of other benefits. All benefits and incentives are subject to eligibility requirements.
About dsm-firmenich
At dsm-firmenich, we don't just meet expectations - we go beyond them.
Join our global team powered by science, creativity, and a shared purpose: to bring progress to life.
From elevating health to making fortified food and sustainable skincare, the impact of your work here will be felt by millions - every single day. Whether it's fragrance that helps you focus, alternative meat that's better for the planet, or reducing sugar without losing flavor, this is where you help shape the future of nutrition, health, and beauty for everyone, everywhere.
And while you're making a difference, we'll make sure you're growing too. With learning that never stops, a culture that lifts you up and the freedom to move across businesses, teams, and borders. Your voice matters here. And your ideas? They're essential to our future.
Because real progress only happens when we go beyond, together.
Inclusion, belonging and equal opportunity statement
At dsm-firmenich, we believe being a force for good starts with the way we treat each other. When people feel supported, included, and free to be themselves, they do their best work - and that's exactly the kind of culture we're building. A place where opportunity is truly equal, authenticity is celebrated, and everyone has the chance to grow, contribute, and feel they belong.
We're proud to be an equal opportunity employer, and we're serious about making our hiring process as fair and inclusive as possible. From inclusive language and diverse interview panels to thoughtful sourcing, we're committed to reflecting the world we serve.
We welcome candidates from all backgrounds - no matter your gender, ethnicity, sexual orientation, or anything else that makes you, you.
And if you have a disability or need any support through the application process, we're here to help - just let us know what you need, and we'll do everything we can to make it work.
Agency statement
We're managing this search directly at dsm-firmenich. If you're applying as an individual, we'd love to hear from you. We're not accepting agency submissions or proposals involving fees or commissions for this role.
$23 hourly 25d ago
Cell Therapy Manufacturing Specialist
Eurofins Us Network 4.4
Exton, PA jobs
Exton, PA, USA Full-time ** The work we do at Eurofins Professional Scientific Services matters, and so do our employees. At Eurofins PSS, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.
**If you're looking for a rewarding career, a place to call home, apply with us today!**
**Job Description**
The Cell Therapy Manufacturing Specialist is responsible for executing critical manufacturing operations to support the daily production of sterile, clinical‑grade cell therapy products. This role operates predominantly within a cleanroom environment under current Good Manufacturing Practices (cGMP) and requires strong aseptic technique, attention to detail, and commitment to quality.
**Key Responsibilities**
**Aseptic Processing & Cell Culture Operations**
+ Perform advanced aseptic processing activities, including media exchanges, vessel passaging, harvest, and cryopreservation of mammalian cells according to the production schedule.
+ Complete and maintain qualifications in aseptic gowning, aseptic process execution, and cleaning/disinfection.
+ Prepare media, buffers, and reagents as needed to support manufacturing activities.
+ Operate, maintain, and perform basic troubleshooting on production equipment.
+ Conduct equipment cleaning, disinfection, and preventative maintenance tasks in accordance with SOPs.
**Documentation, Compliance & Quality**
+ Execute, review, and contribute to the revision and authorship of SOPs and Master Batch Records (MBRs) under cGMP guidelines.
+ Open, investigate, and close quality records including deviations, CAPAs, and change controls.
+ Initiate and support simple change controls; complete associated tasks in a timely manner.
+ Ensure accuracy and compliance of all documentation in accordance with data integrity standards and company policies.
+ Achieve PowerUser proficiency in supporting electronic systems (e.g., MasterControl).
**Operational Support & Collaboration**
+ Perform inventory management activities for consumables, media, cryovials, and other materials.
+ Assist with material procurement, receipt, and traceability.
+ Train colleagues on foundational process steps, equipment operation, and support tasks.
+ Maintain a safe and compliant working environment, ensuring adherence to all SOPs and industry best practices.
+ Participate in continuous improvement initiatives and process optimization projects.
+ Effectively manage time and multitask to meet production and documentation deadlines.
**Qualifications**
**Education**
+ Bachelor's degree in a scientific discipline **or** equivalent direct industry experience.
**Experience & Skills**
+ **2+ years of industry experience** in mammalian cell culture within a GMP-regulated biopharmaceutical, cell therapy, or biotechnology manufacturing environment.
+ Demonstrated proficiency in aseptic technique and common laboratory skills (pipetting, cell handling, media preparation) gained through **real-world manufacturing or industrial lab experience** .
+ Strong understanding of mammalian cell biology and its application to **cell therapy production environments** .
+ Comfort working fully gowned in a cleanroom environment, with direct experience in **classified cleanroom operations** .
+ Familiarity with 21 CFR Part 11, GxP expectations, and **industry regulatory standards** for manufacturing.
+ Excellent verbal and written communication skills.
+ Strong interpersonal skills; able to work effectively in a team-oriented, production-focused setting.
+ Willingness to work evenings, weekends, and holidays as manufacturing demands require.
**Additional Information**
**What to Expect in the Hiring Process:**
+ 10-15 Minute Phone Interview with Region Recruiter
+ 45-60 Minute Virtual Interview with Manager and/or Group Leader
**Additional Details:**
This is a full-time, onsite position based on a first-shift schedule (Monday through Friday, 8:00am to 5:00pm), with overtime required as needed. Candidates located within a commutable distance to Exton, PA are strongly encouraged to apply.
**Excellent full-time benefits include:**
+ comprehensive medical coverage, dental, and vision options
+ Life and disability insurance
+ 401(k) with company match
+ Paid vacation and holidays
**_Ready to take the next step in your career?_**
**_Apply today and join a team that's making a difference in science every day._**
**Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.**
$27k-42k yearly est. 8d ago
Cell Therapy Manufacturing Specialist
Eurofins Scientific 4.4
Exton, PA jobs
The work we do at Eurofins Professional Scientific Services matters, and so do our employees. At Eurofins PSS, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.
If you're looking for a rewarding career, a place to call home, apply with us today!
Job Description
The Cell Therapy Manufacturing Specialist is responsible for executing critical manufacturing operations to support the daily production of sterile, clinical‑grade cell therapy products. This role operates predominantly within a cleanroom environment under current Good Manufacturing Practices (cGMP) and requires strong aseptic technique, attention to detail, and commitment to quality.
Key Responsibilities
Aseptic Processing & Cell Culture Operations
* Perform advanced aseptic processing activities, including media exchanges, vessel passaging, harvest, and cryopreservation of mammalian cells according to the production schedule.
* Complete and maintain qualifications in aseptic gowning, aseptic process execution, and cleaning/disinfection.
* Prepare media, buffers, and reagents as needed to support manufacturing activities.
* Operate, maintain, and perform basic troubleshooting on production equipment.
* Conduct equipment cleaning, disinfection, and preventative maintenance tasks in accordance with SOPs.
Documentation, Compliance & Quality
* Execute, review, and contribute to the revision and authorship of SOPs and Master Batch Records (MBRs) under cGMP guidelines.
* Open, investigate, and close quality records including deviations, CAPAs, and change controls.
* Initiate and support simple change controls; complete associated tasks in a timely manner.
* Ensure accuracy and compliance of all documentation in accordance with data integrity standards and company policies.
* Achieve PowerUser proficiency in supporting electronic systems (e.g., MasterControl).
Operational Support & Collaboration
* Perform inventory management activities for consumables, media, cryovials, and other materials.
* Assist with material procurement, receipt, and traceability.
* Train colleagues on foundational process steps, equipment operation, and support tasks.
* Maintain a safe and compliant working environment, ensuring adherence to all SOPs and industry best practices.
* Participate in continuous improvement initiatives and process optimization projects.
* Effectively manage time and multitask to meet production and documentation deadlines.
Qualifications
Education
* Bachelor's degree in a scientific discipline or equivalent direct industry experience.
Experience & Skills
* 2+ years of industry experience in mammalian cell culture within a GMP-regulated biopharmaceutical, cell therapy, or biotechnology manufacturing environment.
* Demonstrated proficiency in aseptic technique and common laboratory skills (pipetting, cell handling, media preparation) gained through real-world manufacturing or industrial lab experience.
* Strong understanding of mammalian cell biology and its application to cell therapy production environments.
* Comfort working fully gowned in a cleanroom environment, with direct experience in classified cleanroom operations.
* Familiarity with 21 CFR Part 11, GxP expectations, and industry regulatory standards for manufacturing.
* Excellent verbal and written communication skills.
* Strong interpersonal skills; able to work effectively in a team-oriented, production-focused setting.
* Willingness to work evenings, weekends, and holidays as manufacturing demands require.
Additional Information
What to Expect in the Hiring Process:
* 10-15 Minute Phone Interview with Region Recruiter
* 45-60 Minute Virtual Interview with Manager and/or Group Leader
Additional Details:
This is a full-time, onsite position based on a first-shift schedule (Monday through Friday, 8:00am to 5:00pm), with overtime required as needed. Candidates located within a commutable distance to Exton, PA are strongly encouraged to apply.
Excellent full-time benefits include:
* comprehensive medical coverage, dental, and vision options
* Life and disability insurance
* 401(k) with company match
* Paid vacation and holidays
Ready to take the next step in your career?
Apply today and join a team that's making a difference in science every day.
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
$27k-42k yearly est. 9d ago
Manufacturing Technician
Frontage Laboratories 3.9
Exton, PA jobs
Job Description
ManufacturingTechnician
Title: ManufacturingTechnician
Full-time
Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Position Summary:
Responsible for maintaining GMP Cleanrooms, equipment, performing manufacturing procedures and executing diverse tasks in various clinical trial material processing areas. Follows cGMP requirements as well as policies and procedures of the business.
The ideal candidate will have working experience in a regulated pharma or biotech environment (GMP, SOPs, Cleanroom and Equipment Maintenance etc.).
Position Responsibilities:
Participate in cleaning and set up of equipment and clean/disinfect cleanrooms rooms as necessary. Monitor and record readings of equipment and systems.
Executes and monitors manufacturing processes according to operational procedures.
Verifies parameters to ensure CGMP and GLP compliance.
Takes samples and performs tests during process according to standard procedures.
Participates in projects focused on process development and/or improvement, cost controls and new product manufacturing.
Troubleshoots equipment issues. Performs equipment maintenance, conditioning, standardization, and calibration as needed.
Handles, stores, and disposes of hazardous and nonhazardous materials incompliance with company policy and regulatory requirements.
Handles chemicals appropriately using required safety equipment. Participates in the execution of validation/revalidation protocols.
Individuals with sterile work environment, buffer formulation, aseptic cleanroom operations experience is a preference.
Candidates will also be required to gown up, so they need to be screened for their comfort with gowning.
Perform tasks assigned by his/her manager per procedures and practices compliant with cGMP.
Perform moderate to high complexity pharmaceutical processing and testing procedures.
Meet the quality and quantity production and testing goals established by the department and appropriately manage any exceptions.
Educational Background/ Experience
High School Diploma, Technical, or Associate degrees is required.
1+ years of experience in the pharma, chemical, biotech industry or related field
Must be able to read, understand, and follow the company's SOP's, policies and practices.
Ability to perform physical duties including lifting and carrying up to 50 lbs. / Walking, standing, bending, stooping
Potential exposure to particulates, vapors or noisy environment. Must be able to wear a Respirator or Dust Mask.
Experience with cGMP guidelines.
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability
.
$27k-41k yearly est. 7d ago
Manufacturing Technician
Frontage Laboratories 3.9
Exton, PA jobs
ManufacturingTechnician
Title: ManufacturingTechnician
Full-time
Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Position Summary:
Responsible for maintaining GMP Cleanrooms, equipment, performing manufacturing procedures and executing diverse tasks in various clinical trial material processing areas. Follows cGMP requirements as well as policies and procedures of the business.
The ideal candidate will have working experience in a regulated pharma or biotech environment (GMP, SOPs, Cleanroom and Equipment Maintenance etc.).
Position Responsibilities:
Participate in cleaning and set up of equipment and clean/disinfect cleanrooms rooms as necessary. Monitor and record readings of equipment and systems.
Executes and monitors manufacturing processes according to operational procedures.
Verifies parameters to ensure CGMP and GLP compliance.
Takes samples and performs tests during process according to standard procedures.
Participates in projects focused on process development and/or improvement, cost controls and new product manufacturing.
Troubleshoots equipment issues. Performs equipment maintenance, conditioning, standardization, and calibration as needed.
Handles, stores, and disposes of hazardous and nonhazardous materials incompliance with company policy and regulatory requirements.
Handles chemicals appropriately using required safety equipment. Participates in the execution of validation/revalidation protocols.
Individuals with sterile work environment, buffer formulation, aseptic cleanroom operations experience is a preference.
Candidates will also be required to gown up, so they need to be screened for their comfort with gowning.
Perform tasks assigned by his/her manager per procedures and practices compliant with cGMP.
Perform moderate to high complexity pharmaceutical processing and testing procedures.
Meet the quality and quantity production and testing goals established by the department and appropriately manage any exceptions.
Educational Background/ Experience
High School Diploma, Technical, or Associate degrees is required.
1+ years of experience in the pharma, chemical, biotech industry or related field
Must be able to read, understand, and follow the company's SOP's, policies and practices.
Ability to perform physical duties including lifting and carrying up to 50 lbs. / Walking, standing, bending, stooping
Potential exposure to particulates, vapors or noisy environment. Must be able to wear a Respirator or Dust Mask.
Experience with cGMP guidelines.
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability
.
$27k-41k yearly est. Auto-Apply 60d+ ago
Manufacturing Tech I
Cresco Labs 4.2
Brookville, PA jobs
Cresco Labs is one of the largest public, vertically integrated, multistate operators in the cannabis industry. Our portfolio of in-house cultivated and manufactured brands features some of the highest quality, most awarded and most popular cannabis products in America. With dozens of locations nationwide, our owned and operated Sunnyside dispensaries provide a welcoming, positive, judgement-free place to shop for anyone at any point on their cannabis journey.
Founded in 2013, Cresco Labs' mission is to normalize and professionalize cannabis through our passionate employees. As stewards of the cannabis industry, our teams are constantly focused on supporting the needs of our fellow colleagues, consumers, customers, and communities alike. With a focus on Social Equity and Educational Development, our SEEDTM initiative ensures that our company reflects the communities in which we serve, ensuring equal opportunity for all to have the knowledge and resources to work in and own businesses in cannabis.
At Cresco Labs, we aim to revolutionize and lead the nation's cannabis industry with a focus on quality and consistency of product, and to bring legitimacy to the industry with the highest level of integrity and professionalism.
If you're interested in joining our mission, click the below links to join our team today!
MISSION STATEMENT
At Cresco, we aim to lead the nation's cannabis industry with a focus on regulatory compliance, product consistency, and customer satisfaction. Our operations bring legitimacy to the cannabis industry by acting with the highest level of integrity, strictly adhering to regulations, and promoting the clinical efficacy of cannabis. As Cresco grows, we will operate with the same level of professionalism and precision in each new market we move in to.
SCHEDULE
Monday - Friday, 7AM - 3:30PM
JOB SUMMARY
Cresco Labs is seeking Lab Technician to join our facility. The ManufacturingTechnician will be responsible for assisting in product processing and formulation. The Lab Technician completes tasks assigned by the Manufacturing Manager to complete post-extraction processing steps, compounding of formulated products, and monitor and maintain the organization and cleanliness of the production areas. The Lab Technician is also responsible for carrying out day-to-day tasks, including working with extraction and packaging when needed.
CORE JOB DUTIES
* Responsible for completing post-extraction processing of cannabis oils, including winterization, activation, evaporation and filtration
* Responsible for manufacturing formulated products including but not limited to capsules, tinctures, lotions, patches, and bulk oils
* Documents production accurately, legibly and completely in batch records and logbooks
* Complete the sanitation of all production equipment and tools including workspace, manufacturing equipment, containers, and appliances.
* Maintains organization of the lab and manufacturing areas, monitors and orders supplies, and performs product inventory
* Complete lab benchwork and sample preparations as directed
* Assist in extraction and packaging departments as needed,
REQUIRED EXPERIENCE, EDUCATION AND SKILLS
* Two years of experience in a lab or manufacturing environment
* Past experience in a highly regulated field producing pharmaceutical or nutraceutical products preferred
* Effective time-management skills and ability to multi-task
* Ability to work in a fast-paced, changing and challenging environment
* Proficiency in windows-based software and point of sale applications
* Proven ability to adhere strictly to health and safety policies
BENEFITS
Cresco Labs is proud to offer eligible employees a robust offering of benefits including, major medical, dental and vision insurance, a 401(K)-match program, FSA/HSA programs, LTD/STD options, life insurance and AD&D. We also offer eligible employees paid holidays and paid time off. Other rewards may include annual discretionary bonuses, stock options as well as participation in our employee discount program. Benefits eligibility for permanent positions may vary by full-time or part-time roles, location, or position.
In accordance with any local and state compensation laws, the compensation listed is the current estimated range for the position. Final offer details and future compensation may be determined by multiple factors including but not limited to, geographic location, market compensation data, skills, experience, and other relevant factors. For questions about this please discuss with your recruiter during the interview process.
Pay Range
$19-$19 USD
ADDITIONAL REQUIREMENTS
* Must be 21 years of age or older to apply
* Must comply with all legal or company regulations for working in the industry
Cresco Labs is an Equal Opportunity Employer and all applicants will be considered without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.
California Consumer Privacy Act ("CCPA") Notice to Applicants:
Please read the California Employee Privacy Notice ("CA Privacy Notice") regarding Sunnyside* and its affiliate Cresco Labs' policies pertaining to the collection, use, and disclosure of personal information. This CA Privacy Notice supplements the information contained in the Sunnyside* Privacy Policy and applies to California resident employees and job applicants. Applicants with disabilities may access this notice in an alternative format by contacting *************************
Reporting a Scam:
Cresco Labs is aware of fictitious employment offers being circulated from various sources. Many of these schemes consist of an alleged offer of employment with Cresco Labs with the intention of gaining personal information, including payment and/or banking information. Be aware that fraudulent job offers and correspondence may appear legitimate: they may feature a Cresco Labs logo, they may appear to originate from an official-looking email address or web site, or they may be sent by individuals purporting to represent Cresco Labs or an entity which includes the word Cresco Labs in its name.
Please note that Cresco Labs does not ask for payment or personal banking information as a condition of employment. Any personal information is requested for payroll or state badging purposes only. Applications can be securely submitted through our career's pages.
We are working diligently to block this from happening. Beware if an offer of employment looks too good to be true. Never divulge personal and banking information or send money if you are unsure of the authenticity of an email or other communication in the name of Cresco Labs.
If you are in doubt, please contact us at **************************** with questions.
$19-19 hourly Auto-Apply 1d ago
Packaging Technician- 2nd Shift
Catalent 4.4
Philadelphia, PA jobs
Packaging Technician
(2nd shift)
Work Schedule: Monday - Friday, 4:00pm to 12:10am.
100% on-site
This is a Union role
Please Note: Occasional weekend work is required.
Position Summary:
Catalent is a global leader in development, manufacturing, and clinical supply services for pharmaceuticals, biologics, and cell and gene therapies. Our 206,878 sq. ft. Philadelphia-area facility serves as the global Center of Excellence for Clinical Supply Packaging, offering GMP secondary packaging and clinical labeling services. We provide manual, semi-automated, and automated packaging solutions for studies of all sizes, including temperature-controlled and frozen packaging capabilities for sensitive products. Come and be part of a team that delivers industry-leading quality and innovation.
The Operations Department is responsible for providing customized innovative manufacturing and packaging solutions. The department oversees all manufacturing and production aspects of quality packaging and labeling of our customer's clinical trial projects.
This position must be able to work in a team environment to offer quality packaging and labeling of customer's clinical trials. Employees will be involved with handling look-alike products and labeling. Clinical operations can be run as a blister fill, bottle fill, pouch, carding, vial/syringe inspection or hand assembly. Employees will also be involved with de-inking of product and capsule manufacturing. These individuals must be detail oriented in order to work with multiple look-alike products at the same time
The Role:
Inspect blister cavities, bottles, pouches, vials, ampoules, syringes, and sealed clinical cards for defects such as missing product, poor seals, misaligned closures, print errors, or contamination.
Perform hand counts of product using trays and fill tablet, bottle, desiccant, and closure hoppers.
Support manufacturing tasks including de-inking product, tablet breaking, oversized capsule filling, and capsule inspection.
Place blister units into assigned card locations for multi-fill operations, following product assignment requirements on look-alike or multi-fill projects.
Inspect and verify clinical labels, ensuring 100% accountability for both manual and automated applications.
Operate barcode scanners and computers for packaging and assembly work.
Perform cleaning of product contact parts, machine equipment, and production rooms according to SOPs and logbook requirements.
Execute sanitation tasks using the three-bucket mop system for ceilings, walls, and floors.
Work in cold storage environments as required, handling products both inside and outside refrigerated conditions.
Adhere to all SOPs, safety, and quality requirements while ensuring accuracy and compliance in all packaging operations.
Other duties as assigned.
The Candidate:
High School Diploma or equivalent.
2+ years previous production or warehouse experience preferred.
Ability to read and interpret customer specifications, cGMPs, SOPs, and follow written/oral instructions accurately while communicating effectively.
Demonstrates attentiveness, professionalism, good personal hygiene, and strong teamwork skills in a fast-paced environment.
Able to troubleshoot problems, report issues, and follow all plant safety guidelines.
Physically capable of standing, walking, sitting, and occasionally lifting up to 25 lbs; must meet vision requirements for reading documents and computer use.
Willingness to work overtime, frequently in cold environments, and perform sanitation/cleaning tasks (e.g., mopping walls, floors, ceilings, equipment).
Accessible to both manufacturing floor and office staff, with ability to operate required office equipment.
Position Benefits:
Diverse, inclusive culture
Several Employee Resource Groups focusing on D&I
Dynamic, fast-paced work environment
Positive working environment focusing on continually improving processes to remain innovative
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
Competitive salary
Community engagement and green initiatives
Medical, dental and vision benefits effective after 90-day probationary period
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
$33k-42k yearly est. Auto-Apply 3d ago
Supervisor Manufacturing
Frontage Laboratories 3.9
Exton, PA jobs
Manufacturing Manager
Title: Manager, Manufacturing Operations
Reports to : Vice President, PD & Manufacturing
Full-time
Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Position/Job Summary:
The Manager Manufacturing Operations position is responsible for all aspects of Clinical Trial Material manufacturing for the company. Accountabilities include manufacturing staff supervision, facility and equipment qualification, technology transfer, scheduling, and management of manufacturing projects. Manufacturing projects span multiple disciplines including, but not limited to material sourcing, process development, analytical testing, and business development. Develop and implement technically sound batch records, SOPs, specifications, protocols, and reports as required, while adhering to CGMP and GDP. Manage manufacturing activities and interaction/compliance with clients and appropriate regulatory authorities as needed.
Roles & Responsibilities:
Manage the manufacturing and supply of clinical trial materials (CTM), for Oral Solid Doses and Sterile drug product for clinical studies from development till post-marketing.
Manage a team of manufacturing technologists, operators, and warehouse coordinators.
Interface with product development team for transfer of knowledge and processes for CTM Batch Manufacturing
Collaborate with other teams including but not limited to product development, procurement, supply chain, analytical testing, quality assurance and business development to ensure proper project execution.
Develop and implement technically sound clinical Manufacturing batch records, SOPs, protocols, and specifications as required.
Manage review quality control records, Change Controls, CAPAs and other GMP related documents and support on-time closure of deviations and CAPAs.
Partner with CMC project management for alignment on and prioritization within manufacturing timelines to deliver CTM.
Write, review and approve SOP's, qualification protocols, and other GMP documentation.
Develop and maintain strategic partnerships with technical and operational colleagues to optimally collaborate with other departments and clients.
Implements site initiatives in production operation as advised by site management.
Ensures manufacturing, testing and CTM labeling/shipping/packaging is done according to guidelines and specifications.
Execution and overseeing of facility and equipment qualification/validation which includes authoring specification, protocols, and writing reports.
Responsible for compliance monitoring of area operations.
Participates in regulatory and customer audits/inspections. Collaborates with functional departments to resolve issues.
Process and analyze manufacturing results, data and provide status updates to the management.
Establish and maintain positive relationships with project stakeholders.
Education, Experience & Skills Required:
Bachelor's Degree in Pharmaceuticals, Engineering or Sciences 8+ years in the pharmaceutical industry.
Strong experience in tech transfer, process development, facility & equipment validation/qualification, and pharmaceutical manufacturing.
5+ years of people management experience.
Experience with cGMP guidelines and regulations. Strong knowledge of FDA, EMEA & ISO regulations.
Strong oral and written communication and interpersonal skills. Ability to work well in a team environment, eager, adaptable.
Ability to perform frequent physical tasks with strength and mobility.
Experience in microbiology and sterile manufacturing is a plus.
Salary and Benefits :
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
$60k-85k yearly est. Auto-Apply 21d ago
Supervisor Manufacturing
Frontage Laboratories 3.9
Exton, PA jobs
Job Description
Manufacturing Manager
Title: Manager, Manufacturing Operations
Reports to: Vice President, PD & Manufacturing
Full-time
Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Position/Job Summary:
The Manager Manufacturing Operations position is responsible for all aspects of Clinical Trial Material manufacturing for the company. Accountabilities include manufacturing staff supervision, facility and equipment qualification, technology transfer, scheduling, and management of manufacturing projects. Manufacturing projects span multiple disciplines including, but not limited to material sourcing, process development, analytical testing, and business development. Develop and implement technically sound batch records, SOPs, specifications, protocols, and reports as required, while adhering to CGMP and GDP. Manage manufacturing activities and interaction/compliance with clients and appropriate regulatory authorities as needed.
Roles & Responsibilities:
Manage the manufacturing and supply of clinical trial materials (CTM), for Oral Solid Doses and Sterile drug product for clinical studies from development till post-marketing.
Manage a team of manufacturing technologists, operators, and warehouse coordinators.
Interface with product development team for transfer of knowledge and processes for CTM Batch Manufacturing
Collaborate with other teams including but not limited to product development, procurement, supply chain, analytical testing, quality assurance and business development to ensure proper project execution.
Develop and implement technically sound clinical Manufacturing batch records, SOPs, protocols, and specifications as required.
Manage review quality control records, Change Controls, CAPAs and other GMP related documents and support on-time closure of deviations and CAPAs.
Partner with CMC project management for alignment on and prioritization within manufacturing timelines to deliver CTM.
Write, review and approve SOP's, qualification protocols, and other GMP documentation.
Develop and maintain strategic partnerships with technical and operational colleagues to optimally collaborate with other departments and clients.
Implements site initiatives in production operation as advised by site management.
Ensures manufacturing, testing and CTM labeling/shipping/packaging is done according to guidelines and specifications.
Execution and overseeing of facility and equipment qualification/validation which includes authoring specification, protocols, and writing reports.
Responsible for compliance monitoring of area operations.
Participates in regulatory and customer audits/inspections. Collaborates with functional departments to resolve issues.
Process and analyze manufacturing results, data and provide status updates to the management.
Establish and maintain positive relationships with project stakeholders.
Education, Experience & Skills Required:
Bachelor's Degree in Pharmaceuticals, Engineering or Sciences 8+ years in the pharmaceutical industry.
Strong experience in tech transfer, process development, facility & equipment validation/qualification, and pharmaceutical manufacturing.
5+ years of people management experience.
Experience with cGMP guidelines and regulations. Strong knowledge of FDA, EMEA & ISO regulations.
Strong oral and written communication and interpersonal skills. Ability to work well in a team environment, eager, adaptable.
Ability to perform frequent physical tasks with strength and mobility.
Experience in microbiology and sterile manufacturing is a plus.
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
$60k-85k yearly est. 15d ago
Supervisor Manufacturing
Frontage Laboratories 3.9
Exton, PA jobs
Manufacturing Manager
Title: Manager, Manufacturing Operations
Reports to: Vice President, PD & Manufacturing
Full-time
Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Position/Job Summary:
The Manager Manufacturing Operations position is responsible for all aspects of Clinical Trial Material manufacturing for the company. Accountabilities include manufacturing staff supervision, facility and equipment qualification, technology transfer, scheduling, and management of manufacturing projects. Manufacturing projects span multiple disciplines including, but not limited to material sourcing, process development, analytical testing, and business development. Develop and implement technically sound batch records, SOPs, specifications, protocols, and reports as required, while adhering to CGMP and GDP. Manage manufacturing activities and interaction/compliance with clients and appropriate regulatory authorities as needed.
Roles & Responsibilities:
Manage the manufacturing and supply of clinical trial materials (CTM), for Oral Solid Doses and Sterile drug product for clinical studies from development till post-marketing.
Manage a team of manufacturing technologists, operators, and warehouse coordinators.
Interface with product development team for transfer of knowledge and processes for CTM Batch Manufacturing
Collaborate with other teams including but not limited to product development, procurement, supply chain, analytical testing, quality assurance and business development to ensure proper project execution.
Develop and implement technically sound clinical Manufacturing batch records, SOPs, protocols, and specifications as required.
Manage review quality control records, Change Controls, CAPAs and other GMP related documents and support on-time closure of deviations and CAPAs.
Partner with CMC project management for alignment on and prioritization within manufacturing timelines to deliver CTM.
Write, review and approve SOP's, qualification protocols, and other GMP documentation.
Develop and maintain strategic partnerships with technical and operational colleagues to optimally collaborate with other departments and clients.
Implements site initiatives in production operation as advised by site management.
Ensures manufacturing, testing and CTM labeling/shipping/packaging is done according to guidelines and specifications.
Execution and overseeing of facility and equipment qualification/validation which includes authoring specification, protocols, and writing reports.
Responsible for compliance monitoring of area operations.
Participates in regulatory and customer audits/inspections. Collaborates with functional departments to resolve issues.
Process and analyze manufacturing results, data and provide status updates to the management.
Establish and maintain positive relationships with project stakeholders.
Education, Experience & Skills Required:
Bachelor's Degree in Pharmaceuticals, Engineering or Sciences 8+ years in the pharmaceutical industry.
Strong experience in tech transfer, process development, facility & equipment validation/qualification, and pharmaceutical manufacturing.
5+ years of people management experience.
Experience with cGMP guidelines and regulations. Strong knowledge of FDA, EMEA & ISO regulations.
Strong oral and written communication and interpersonal skills. Ability to work well in a team environment, eager, adaptable.
Ability to perform frequent physical tasks with strength and mobility.
Experience in microbiology and sterile manufacturing is a plus.
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
$60k-85k yearly est. Auto-Apply 60d+ ago
Manufacturing Support Technician
Krystal Biotech 4.0
Manufacturing technician job at Krystal Biotech
About Krystal Bio: At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs.
Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient's end-to-end experience.
Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK , for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology.
Krystal is headquartered in Pittsburgh, PA, which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity. As we grow, we are seeking team members that embody these values.
Job Description Summary:
Krystal Biotech, Inc is seeking a highly motivated Manufacturing Support Technician to support our commercial manufacturing facility in the South Side. The Technician will work closely with the manufacturing team to uphold cleanroom standards, follow strict procedures, and contribute to the smooth operation of all manufacturing processes.
Primary Responsibilities:
Assist in the setup, breakdown, and cleaning of equipment and manufacturing areas before and after production runs
Collaborate with manufacturing and quality teams to ensure that facilities are prepared and ready for production activities as per schedule
Execute and maintain strict cleaning and sanitization protocols in compliance with current Good Manufacturing Practices (cGMP) guidelines and Standard Operating Procedures (SOPs)
Conduct routine inspections of cleanrooms to identify any cleanliness or contamination issues, promptly reporting and addressing them according to established procedures
Follow and document all procedures, including batch records, cleaning logs, and any other required documentation accurately and in a timely manner
Adhere to safety protocols and guidelines, including proper handling and disposal of hazardous waste materials
Support the maintenance of process gas levels, calibration of equipment, and preventative maintenance schedules
Participate in training sessions and meetings to stay updated on the latest industry standards, regulations, and best practices
Assist with movement of materials; work with EHS/Materials Teams for collection and dispensing of biohazardous waste
Support a standard 40-hour work week with flexibility to support occasional off-shift hours and/or weekends
Perform other tasks, as assigned
Requirements and Preferred Qualifications:
High school diploma or equivalent is required; additional technical or vocational training in biopharma manufacturing, cleanroom operations, or related fields is a plus
In lieu of direct experience, bachelor's degrees in applicable fields such as life sciences or engineering will be considered
Experience with sanitization, aseptic technique and/or sterile processes in a regulated setting (GMP, ISO) is highly preferred
Ability to follow detailed instructions and maintain accurate documentation
Excellent attention to detail, organization skills, and the ability to prioritize and multitask effectively in a fast-paced environment
Demonstrated commitment to safety protocols and adherence to standard operating procedures
Excellent communication and the ability to work well both independently and as part of a team
Physical stamina and the ability to stand, bend, and lift heavy objects when necessary
Flexibility to work shifts, including evenings, weekends, and holidays as required.
Krystal Biotech, Inc. is an Equal Employment Opportunity and Affirmative Action Employers. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter and agency resumes. Krystal Biotech, Inc. will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc.
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$29k-42k yearly est. 27d ago
PHL_Engineering Technician
PCI Pharma Services 4.1
Philadelphia, PA jobs
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Summary of Objective:
All activities are focused around technical and operational support to the production, maintenance, and support staffs in the areas of process improvement, equipment modification and optimization, safety and quality improvement, and increasing throughput. This is achieved through individual effort and participation of teams, tracking and analysis metrics, a basic understanding and utilization of good engineering practices, and the use of Lean Six Sigma techniques. Additional responsibilities include supporting the Business Units and plant Operations with serialization tasks and systems.
**Essential Duties and Responsibilities:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
+ For assigned equipment projects, take the primary responsibility for the installation, setup and testing of packaging equipment including but not limited to the following:
+ Moving and placing equipment
+ Connecting mechanically and/or electrically
+ Setting and Testing equipment
+ Building programs/recipes
+ Vendor management
+ Cross functional collaboration
+ Customer interaction
+ Equipment Safety
+ Equipment Reliability
+ Equipment Performance
+ Lead the field activities for Process Line Trials (PLT's) and Engineering trials of packaging equipment related topics.
+ Mechanical equipment
+ Electrical equipment
+ Control instrumentation
+ Troubleshooting
+ Provide expertise and training to the Mechanical team for packaging equipment related topics as the equipment Subject Matter Expert (SME)
+ Conducts and/or participates in customer meetings and attends occasional off-site meetings. Interacts with Sales and customers to determine requirements for new products/orders.
+ Participates in internal review meetings to plan new jobs with plant Operations, Maintenance, Quality, Purchasing and Process Engineering.
+ Prepares Standard Operating Procedures (SOPs), line layouts, production line diagrams as needed.
+ Assist with Factory & Site Acceptance Testing (FAT/SAT) for all assigned projects.
+ Develop design criteria and equipment specifications, including safety, regulatory and necessary performance criteria.
+ Responsible for determining Operational Qualification (OQ) parameters to start validation.
+ Coordination of outside design, integration, and equipment manufacturing services.
+ Assist Validation with OQ and Process Qualifications (PQ) of new packaging business.
+ Write and modify SOPs relating to the production area and assist in training of affected personnel.
+ Assists with Corrective And Preventative Actions (CAPA) investigations and actions. Initiate investigation activity and troubleshoot problems in packaging; discovers causes of non-conformance, i.e., slow throughput, poor quality and/or unsafe design.
+ Applies sound engineering principles to improve existing equipment, packaging design and processes by reducing waste, increasing throughput, reducing energy consumption or eliminating human interaction through automation.
+ Measure and analyze performance metrics of the production area and spearhead initiatives to decrease variability and waste.
+ Creates and modifies Antares recipes for products run on lines with Antares Tracking System.
+ Maintains and operates the Antares Warehouse Tracking System (WTS) process.
SUPERVISORY RESPONSIBILITIES:
+ No supervisory responsibilities.
**Work Environment:** The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Office and Production floor environment.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
**Qualifications:** The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
+ Associate or technical degree in mechanical science, electrical science or instrumentation control, or minimum of 5-8 years of experience with automated packaging equipment.
+ Minimum of 3 years of relevant experience in a Lean and/or Six Sigma environment.
+ Minimum of 5-8 years of relevant experience with packaging equipment.
+ Lean Six Sigma Background preferred.
+ Pharmaceutical and/or food packaging background preferred.
\#LI-DT1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (*****************
**Equal Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled