Quality Lead Technician
Process technician job at Biolife Plasma Services
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers.
About BioLife Plasma Services
Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.
BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.
OBJECTIVES/PURPOSE
Monitors designated systems and activities, according to tasks trained and assigned, to ensure that source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP), the Shire Quality System, and other applicable regulations for a plasma center. Is able to perform all technical tasks required within the work areas and will work in these areas as a Lead Technician (or Center Supervisor by exception) when not acting as the Quality Lead Technician.
All below listed responsibilities must be completed in compliance with federal, state, local and company-specific regulations related to quality of product, employee and donor safety, and to the proper performance of day-to-day activities. Employees must also maintain complete and accurate records, in accordance with cGMP.
ACCOUNTABILITIES
Performs duties associated with Quality (including but not limited to): (50%)
Reviews operational records in association with tasks trained and assigned to ensure they are complete, accurate and compliant with cGMP requirements.
Tracks deviations in operating procedures and policies through established mechanisms. Reports error, deficiencies, discrepancies and observations to center management and Quality Management Representative (QMR).
Conducts monthly quality assurance audits for critical control points and key elements for the systems related to donor suitability, source plasma collection, sample collection, plasma storage, product release, quality assurance, and employee training program.
Ensures SOP's are current and that staff perform routine tasks according to SOP through direct observation.
In the absence of a QMR, works in collaboration with the management team to prepare for and host (if needed) internal auditors and external inspectors. Assists center management teams to ensure timely closure of observations.
Maintain qualifications and perform all duties (core and elective) for Medical History, Phlebotomy, and Sample Processing areas. Train new and existing staff on donor center procedures through demonstration, instruction, observation, and feedback. (30%)
Provide leadership and training assistance in support of center management and supervisory team, including oversight of operational flow. (10%)
Maintain certification and perform all required duties of Lead Technician. (10%)
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
A minimum of one year of relevant work experience, preferably in a regulated industry, or an equivalent combination of education and experience.
Certification in all three primary operational areas of the plasma center (Medical Historian, Phlebotomy, and Processing Technician).
Completion of all training through Lead Technician. Demonstrated understanding of quality assurance in an FDA-regulated environment.
Effective communication, organizational, and technical/problem-solving skills.
Supports the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes as needed, through use of company approved procedures (including but not limited to 5S, Value Stream Mapping and Kaizen).
Maintain general cleanliness of work area and assist other work areas as needed to ensure a clean and professional environment.
Ability to read and follow Standard Operating Procedures (SOPs) and to maintain complete and accurate records.
Leadership
Integrity
Fairness
Honesty
Perseverance
Putting the patient at the center
Building trust with society
Reinforcing our reputation
Developing the business
Decision-making and Autonomy
Refers to Center Manager for guidance on complex, medium-impact or above decisions (internal)
Refers to management team for escalated donor/employee concerns (internal)
Interaction
Responsible for providing exceptional customer service to donors (external) and fellow employees (internal)
Attend staff meetings and other team meetings as required.
Good verbal communication and customer service skills.
Ability to multi-task and work as a team player.
Innovation
Coordinates will all other center roles to effectively problem solve, ensure safety of staff and donors, and provide an exceptional customer experience.
Complexity
Production environment requiring the ability to walk and stand for the entire work shift.
Requires frequent leaning, bending, stooping, crouching, and reaching above the shoulders and below the knee.
Requires frequent lifting up to 26 lbs. and occasional lifting of materials 32 lbs. - 50 lbs.
Must have fine motor coordination, depth perception, and ability to hear equipment sounds from a distance.
Due to potential exposure to blood borne pathogens (risk level 1), 90% of work tasks require pro-longed glove wear
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Essential: High School Diploma or equivalent required
Desired: Associate or Bachelor's degree preferred
ADDITIONAL INFORMATION
FLSA Classification (US) - Non-Exempt
Other duties and responsibilities as assigned.
BioLife Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - NC - Fayetteville - Morgan
U.S. Hourly Wage Range:
$20.00 - $27.50
The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - NC - Fayetteville - MorganWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Job Exempt
No
Auto-ApplyAdvanced Facilities Operations Technician (SOCIAL CIRCLE)
Social Circle, GA jobs
By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Ready to make your application Please do read through the description at least once before clicking on Apply.
Job DescriptionAbout the role:
As the Maintenance and Utilities Technician V, you will perform advanced maintenance, preventive maintenance, and repairs on a variety of critical plant equipment. You will ensure the smooth operation of manufacturing and facilities equipment, contributing to the efficiency and reliability of Takeda's operations.
How you will contribute:
Perform preventative, corrective, and predictive maintenance on:
HVAC, chillers, boilers, air handlers, refrigeration systems, compressors, pumps, water systems
Diagnose, troubleshoot, and repair control systems, instrumentation, and mechanical systems
Maintain refrigerant logs per EPA/SCAQMD standards
Execute and close work orders (JDE system), including required documentation and Change Control
Escort contractors, support equipment startups, order/manage chemicals
Ensure compliance with NFPA, NEC, UMC, cGMP, and internal safety protocols
Respond to emergency/urgent utility issues and hazardous waste concerns
Participate in team meetings and instructor-led training
Demonstrate increasing technical proficiency over time
What you bring to Takeda:
High School diploma or GED required
8+ years of relevant industrial maintenance experience required
2-year technical certificate (HVAC, Utilities, Building Trades) or military equivalent; Class 3 Industrial Wastewater Certification strongly desired. Automation/controls experience (DeltaV, Honeywell) highly preferred
Experience interpreting schematics, manuals, job plans. Experience with PID loops, Lockout/Tagout, ACAC protocols
Basic understanding of GMPs and regulated environments. Familiar with CMMS (JDE, Maximo), Microsoft Office, SCADA
Important Considerations:
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
Carry up to 25 lbs., lift up to 50 lbs., and push/pull > 100 lbs. (with the assistance of material handling equipment).
Stand for extended periods of time over an entire shift.
Climb ladders and stairs while wearing special gowning.
Perform bending, twisting, reaching overhead, and/or squatting motions to perform certain tasks.
Work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
Will work in a cold, wet environment.
Work multiple shifts, including holidays and shutdown. Must be able to work overtime as required.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
#GMSGQ #ZR1 #LI-MA1
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - GA - Social Circle - Hwy 278
U.S. Hourly Wage Range:
$23.56 - $37.02
The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. xevrcyc U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - GA - Social Circle - Hwy 278Worker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Job Exempt
No
Quality Technician
Portsmouth, NH jobs
The Alexander Technology Group is looking for a Quality Technician for a client in the Portsmouth, NH area.
This is a full-time role
No 3rd party applicants/agencies will be considered, do not reach out.
Salary: 60-75k
Must be on-site
Requirements:
Quality Technician
Perform in-process and final product inspections/testing for device products: Conduct visual/functional checks on assembled devices
Support environmental monitoring and cleanliness in manufacturing/assembly areas: Execute routine sampling and testing (e.g., viable/non-viable particulates, settle plates) in ISO-classified cleanrooms used for assembly, escalate excursions, and assist in gowning qualification and line clearance activities.
Execute sampling and basic analytical testing of incoming materials and in-process samples: Test device components
Document deviations, non-conformances, and support CAPA investigations
Assist in equipment qualification, process validation, and cleaning validation activities
If interested, please send resume to ************************
Formulation Technician I
Bedford, NH 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.
This position will have the primary responsibility for daily formulation activities to ensure schedule activities are completed, formulation materials and equipment are maintained, as well as the responsibility for performing corrective and preventative actions. As a secondary function, provide troubleshooting expertise for manufacturing of products both internally and externally of the company.
**Essential Duties and Responsibilities:**
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The basic duties and responsibilities include the following, but other duties may be assigned.
+ Has ownership for the daily formulation activities to ensure scheduled all scheduled tasks/events are completed
+ Is responsible for critical steps in the formulation process including but not limited to, lab setup and process flows, in-process testing, API dissolution and final QS while ensuring safety, batch integrity and prevention or errors that could lead to product and or finical loss
+ Initiate the production of batch documentation used for engineering and cGMP production.
+ Prepare and update Master Production Batch records and SOPs accurately for communicating and initiate the documentation change process for needed documentation changes
+ Complete executed Batch Records accurately and completely prior to submission to supervision for review
+ Comply with all area SOPs and ensure logbooks are completed, and adhere to cGMP requirements
+ Author process deviations when these occur within the department, participate in investigations, and contribute to identifying corrective and preventative actions
+ Cross train to increase technical skills across the department
+ Accountable for timely communication to management and clients of issues, challenges as well as opportunities for process improvements.
+ As a member of the manufacturing team, you will perform other manufacturing tasks for example filling, capping etc., as needed.
+ Work with enabling groups to improve/implement processes.
+ Other duties as assigned.
+ Strong interpersonal skills
+ Strong working knowledge of MS Office suite is preferable
+ Attention to detail and positive attitude are key attributes
+ Able to follow rules and regulations perfectly
+ Works directly with aseptic and non-aseptic personnel. Works closely with Quality Assurance, MTS, Validation etc.
**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.
**Required:**
+ High School education or AS degree or BS degree in Chemical Engineering/ Bio Chemistry or other industry related discipline is preferred
+ Experience and knowledge of formulation/compounding tools and equipment
+ Minimum 1-2 year's work experience in a GMP environment preferably in fill finish pharmaceutical operations
+ Demonstrated ability to prioritize multiple projects and activities Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
\#LI-KC1
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
Processing Technician I Processing/Packaging
Egg Harbor, NJ jobs
Canopy USA is now positioned to consolidate operations across its three business units - Wana, Jetty, and Acreage - realizing synergies, cost savings, and supporting growth in state-legal markets across the U.S. Through coverage of key market segments including flower via Superflux, vape and concentrates via Jetty, edibles and beverages via Wana, and retail through The Botanist, Canopy USA is well positioned to accelerate growth with an emphasis on the Midwestern and Northeastern U.S. markets
SUMMARY
The Processing Technician will be responsible for various processes associated with the processing and packaging of high quality, cannabis goods. The successful candidate will possess a keen attention to detail and record keeping, and a willingness to continually learn more about the subject. The entry-level position offers the opportunity to learn and grow with the Company from the ground up, and to take on increasing levels of responsibility over time.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
The main responsibilities of the Processing Technician include the processing and handling of cannabis from harvest to packaging; monitoring weights and measurements; presentation; and maintaining the highest level of cleanliness inside the processing area.
* Harvesting plant material
* Bucking, trimming, sifting and other physical manipulation of biomass
* Weighing and packaging cannabis goods of all forms
* Monitoring inventory quality throughout processing steps
* Maintain accurate records and utilize inventory tracking system
* Disposing of waste, as per standard operating procedures
* Thorough cleaning tools, supplies, and work areas
* Other duties as assigned
Competencies:
* Ability to work independently and under pressure
* Broad mechanical aptitude
* Demonstrated ability to work in a physical capacity
* Communication proficiency
* Independent thinking and initiative
* Critical thinking and problem-solving
* Attention to detail
* Good organizational skills
* Ability to effectively use computer-based seed-to-sale inventory software
QUALIFICATIONS
Education and Experience
* High school diploma or equivalent - required
* 2+ years of experience in a warehouse/ industrial assembly line environment preferred
* Familiarity with history and varieties of medical marijuana preferred but not required
Required Knowledge and Abilities
* Basic Math required for inventory, projections, and measurements
* Excellent time-management skills; Ability to effectively plan and prioritize
* Ability to maintain confidentiality; Absolute reliability and honesty
* Ability to focus; Attention to detail
* Ability to work effectively as part of a team; Ability to communicate clearly and calmly
* Ability to remain calm in periods of high stress or unusual activity
* Skill at using computers
* Mechanical skill
Additional Qualifications
* Must be 21 years of age or older
* Ability to pass state mandated background check(s)
SCHEDULE
Available to work Monday-Thursday, 7am-5:30pm ET, with flexibility for mandatory overtime as required to meet business needs.
WORK ENVIRONMENT AND PHYSICAL DEMANDS
The work environment characteristics and physical demands 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.
Production environment. While performing the duties of this job, the employee is frequently exposed to fumes or airborne particles, safety is paramount. The noise level in the work environment and job sites can be loud. The job is performed indoors in a traditional warehouse like setting. Exposure to heat, bright lights and organic chemicals is expected. Protective safety clothing, shoes, glasses, goggles, gloves, facemasks, or hat may be required to be worn.
* Extended time standing, walking, bending, and reaching
* Ability to lift and carry up to 50 pounds for a distance of 100 feet
* Close visual focus required
* Standing for extended period of time in excess of 4 hour increments
ACREAGE HOLDINGS CODE OF CONDUCT
All employees are expected to represent the values and maintain the standards contained in the Code of Conduct.
CHANGES TO THIS
The Company may amend this job description in whole or part, at any time, without notice based on business needs.
E-Verify Participation Notice
This Employer participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
What is E-Verify? E-Verify is an internet-based system that compares information from and employee's Form I-9, Employment Eligibility Verification, to data from the U.S. Department of Homeland Security and Social Security Administration records to confirm employment eligibility.
Code of Conduct:
All employees are expected to represent the values and maintain the standards contained in the Code of Conduct.
The Botanist is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. We appreciate your interest in The Botanist. If you need assistance with completing an online application due to a disability, please send a request to **************************. Please be sure to include "Accommodation Request" in the subject line.
E-Verify Participation Notice
This Employer participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
What is E-Verify? E-Verify is an internet-based system that compares information from and employee's Form I-9, Employment Eligibility Verification, to data from the U.S. Department of Homeland Security and Social Security Administration records to confirm employment eligibility.
#ENGHP
Processing Technician
Freeport, IL jobs
Why In Grown Farms? In Grown Farms is a subsidiary of Canopy USA, LLC, a leading vertically integrated, multi-state operator in the United States cannabis industry. With the transition of Acreage Holdings to Canopy USA, LLC in December 2024, Canopy USA, LLC is now positioned to consolidate operations across its three business units - Wana, Jetty, and Acreage - realizing synergies, cost savings, and supporting growth in state-legal markets across the U.S.
Through coverage of key market segments including flower via Superflux, vape and concentrates via Jetty, edibles and beverages via Wana, and retail through The Botanist, Canopy USA, LLC is well positioned to accelerate growth with an emphasis on the Midwestern and Northeastern U.S. markets. As newly formed Canopy USA, LLC, we are building a stronger, more agile organization that will unlock greater opportunities across the growing US cannabis market.
Who you'll work for: In Grown Farms
Our Culture:
Here at Canopy USA, LLC, we believe in people first. We value our people and encourage continuous opportunities to learn, develop, and grow. We pride ourselves in innovation and passion for the cannabis industry.
We are always looking for motivated people who share our vision to join our team. Think you have what it takes? Then come grow with us!
About the Role: Processing Technician - Trim
The Processing Technician will be responsible for various processes associated with cannabis product development. The Technician provides the daily care and focused attention necessary to process and package clean, high-quality, safe cannabis products. Excellent work environment with a full benefit package offered including medical, dental, vision, 401(k) plan, life insurance, short and long-term disability insurance, paid time off, holidays, pet insurance, and other paid leaves of absence.
How you'll make a difference?(required duties and responsibilities):
Essential Functions and Responsibilities
* Responsible for various processes, may include harvesting, trimming, processing and/or packaging of plant material by hand or machine.
* Inspects plant material for defects using a variety of tools; reports concern in a timely manner to the lead or manager on duty.
* Accurately records data on each plant using Company system and protocols, which may include but is not limited to accurate inventory, weights and measurements of plant material throughout the processing and packaging procedures
* Adhere to specific quality control SOPs regarding procedural operations and quality of product produced; verify quality control standards are being met throughout the process.
* Maintains a clean, compliant, and safe work environment; responsible for reporting any necessary compliance or safety concerns promptly.
* Compliantly clean and sanitize processing area as assigned by management, which may include sweeping and spot mopping, sanitizing surfaces and equipment, reorganizing related stock and inventory.
* Compliantly disposes of waste, in accordance with standard operating procedures.
* Meets daily goals, processing objectives, and KPIs set by management.
* Assists with other tasks as assigned by the Cultivation Manager and/or Director of Production.
Skills to be Successful (minimum qualifications):
Education and Experience
* High school diploma or equivalent
* Minimum of 1-3 years of packaging, trimming, and/or production experience strongly preferred.
* Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary focus and attention to detail.
* Proficient verbal and written communication skills, including ability to effectively communicate with colleagues.
* Ability to work independently and as part of a team to carry out assignments to completion within parameters of instructions given, prescribed routines, and standard accepted practices.
Additional Qualifications
* Must be of the minimum age required by state regulations.
* Ability to pass state mandated background check(s)
Computers and Technology
* Proficient in Microsoft Word, Excel, PowerPoint and Outlook
* Ability to learn, navigate and accurately utilize the company's seed-to-sale tracking software (where
Associate Operator, Production Tech I (2nd Shift) - St. Louis, MO
Saint Louis, MO jobs
Associate Operator, Production Tech I St. Louis, MO, US On-Site To set up machines to order specification for bottling. Fill and label products to order specification. Clean and sanitize equipment between orders. Strict attention to good manufacturing practices and plant safety and sanitation policies.
At dsm-firmenich, being a force for good is not optional. Diversity, Equity & Inclusion is a shared responsibility woven into our daily work, benefiting to our People, Customers & Communities and driving business value. Equal access to opportunities is a given, belonging is a shared feeling, authenticity is celebrated.
Your key responsibilities
* Able to read and understand computer generated batch reports in order to set up machines to order specification.
* Understand and follow Good Manufacturing Practices for the care, handling and storage of food products; and report any known or observed violations to management. Utilize HACCP philosophy and procedures in everyday work routine.
* Must understand and follow all plant policies concerning safety/emergency, conduct, maintenance, sanitation and current procedures designed for the department.
* Able to lift up to and including 50-pound packages in a safe manner as well as handling heavier packages including 55-gallon drums
* Assist Team Leader and Production Supervisor in training new employees and performing competency reviews as needed
* Must understand and follow procedures for pulling product samples for quality analysis
We bring
* Empowerment to make meaningful contributions while upholding ethical standards.
* Recognition and celebration of your efforts and accomplishments
* Opportunities for growth and advancement for those who embrace innovation and take initiative
* Customer-first approach, working with world-renowned brands to turn ideas into impactful solutions
* Responsibility and accountability in living company values and driving sustainable solutions
* Supportive environment where individuals are empowered to progress and contribute to meaningful change
You bring
* High school diploma or equivalent
* Ability to work independently and in accordance with company safety and sanitation standards is required
* Must have 3-5 years related experience
* Previous food plant experience helpful
* Must possess and be able to demonstrate the knowledge, skills, and ability to perform the essential duties and responsibilities of a Production Tech I (kettle packing, serac, pail filler, drum line, flavor room 3 tank operations, label printing, and SAP) and Production Tech II (liquid compounding, emulsions, vanilla blending, vanilla still operation, and SAP
* Willingness and ability to work in a facility with minimal temperature control, exposed to local temperature variations (hot & cold)
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.
Operator, Production Tech II (1st Shift) - St. Louis, MO
Saint Louis, MO jobs
Operator, Production Tech II St. Louis, MO, US On-Site To mix, blend, and formulate batches of raw ingredients and materials into finished product as specified on work orders to include liquid flavors and vanilla items according to formulas, procedures, and quality standards.
At dsm-firmenich, being a force for good is not optional. Diversity, Equity & Inclusion is a shared responsibility woven into our daily work, benefiting to our People, Customers & Communities and driving business value. Equal access to opportunities is a given, belonging is a shared feeling, authenticity is celebrated.
Your key responsibilities
* Verify batch weights and quantities through mathematical calculations
* Understand and follow Good Manufacturing Practices for the care, handling and storage of food products; and report any known or observed violations to management
* Able to lift up to and including 50-pound packages in a safe manner as well as handling heavier packages including 55-gallon drums
* Assist Team Leader and Production Supervisor in training new employees and performing competency reviews as needed
* Properly and accurately sign off for raw materials retrieved, checking for foreign materials, rework generated, finished product produced, date and time completed on computer generated batch reports
* Must understand and follow procedures for pulling product samples for quality analysis
We bring
* Empowerment to make meaningful contributions while upholding ethical standards.
* Recognition and celebration of your efforts and accomplishments
* Opportunities for growth and advancement for those who embrace innovation and take initiative
* Customer-first approach, working with world-renowned brands to turn ideas into impactful solutions
* Responsibility and accountability in living company values and driving sustainable solutions
* Supportive environment where individuals are empowered to progress and contribute to meaningful change
You bring
* High school diploma or equivalent
* Ability to work independently and in accordance with company safety and sanitation standards is required
* Must have 3-5 years related experience
* Previous food plant experience helpful
* Must possess and be able to demonstrate the knowledge, skills, and ability to perform the essential duties and responsibilities of a Production Tech I (kettle packing, serac, pail filler, drum line, flavor room 3 tank operations, label printing, and SAP) and Production Tech II (liquid compounding, emulsions, vanilla blending, vanilla still operation, and SAP
* Willingness and ability to work in a facility with minimal temperature control, exposed to local temperature variations (hot & cold)
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.
Lead Process Technician (3rd Shift)
Kalamazoo, MI jobs
Role Description
The Lead Process Technician plays a critical role in the smooth operation of our pharmaceutical packaging lines. Working within a Lean Manufacturing environment, you will focus on troubleshooting, diagnostics, and continuous improvement of both mechanical and highly automated packaging equipment. Your primary responsibility is to ensure optimal performance, reliability, and compliance with industry standards through proactive maintenance, technical expertise, and a commitment to continuous improvement.
This role is responsible for establishing and enhancing operational processes through the application of Lean principles and methodologies and systematic troubleshooting techniques.
You are recognized as a subject matter expert and serve as on-going technical resource to the operating units, overseeing that cleaning is completed within EHS and/or GMP requirements, working to maximize production efficiency where possible
Responsibilities Include:
Equipment Troubleshooting & Diagnostics:
Specialize in troubleshooting and diagnostics for a wide range of packaging equipment, including mechanical and highly automated systems such as fillers, pick & place robots, cartoners, case packers, labelers, and printers. You will collaborate closely with operations, maintenance, and engineering to prioritize work, reduce downtime, and improve line reliability.
Continuous Improvement:
Proactively review equipment operation, identify deficiencies, and recommend improvements to increase Overall Equipment Effectiveness (OEE) and support Lean Manufacturing initiatives through leading and supporting key projects.
Technical Advisory:
Provide input on projects involving parts and material selection, documentation (OJT and SOP creation), testing, problem solving, maintenance requirements, project scope, and follow-up.
Machine Changeovers:
Provide technical support during machine change-overs for different package sizes and set up packaging lines to ensure smooth startups and increased production efficiency.
Root Cause Analysis:
Initiate and participate in Root Cause Analysis to address recurring issues and implement effective solutions.
Training & Compliance:
Provide training related to the maintenance and operation of mechanical and automated equipment, ensuring compliance with company standards, procedures, and government regulations (SOPs, GMPs, etc.).
Required skills, education, and experience:
Trade certification or degree in engineering, automation, or a related technical field strongly preferred.
10+ years of experience in a manufacturing or packaging environment, especially with highly automated pharmaceutical equipment preferred.
Strong mechanical aptitude and advanced troubleshooting skills.
Familiarity with Lean Manufacturing principles.
Understanding of safety, compliance, and regulatory standards in pharmaceutical operations.
Effective communication and team collaboration skills.
Ability to stand, walk, bend, and lift for extended periods.
Comfortable working in a fast-paced, production-driven environment.
Production Floor presence and support for assigned shift
Able to perform other duties as required.
Full time RegularColleague
Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.
Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
Auto-ApplyLead Process Technician (3rd Shift)
Kalamazoo, MI jobs
Role Description * The Lead Process Technician plays a critical role in the smooth operation of our pharmaceutical packaging lines. Working within a Lean Manufacturing environment, you will focus on troubleshooting, diagnostics, and continuous improvement of both mechanical and highly automated packaging equipment. Your primary responsibility is to ensure optimal performance, reliability, and compliance with industry standards through proactive maintenance, technical expertise, and a commitment to continuous improvement.
* This role is responsible for establishing and enhancing operational processes through the application of Lean principles and methodologies and systematic troubleshooting techniques.
* You are recognized as a subject matter expert and serve as on-going technical resource to the operating units, overseeing that cleaning is completed within EHS and/or GMP requirements, working to maximize production efficiency where possible
Responsibilities Include:
* Equipment Troubleshooting & Diagnostics:
Specialize in troubleshooting and diagnostics for a wide range of packaging equipment, including mechanical and highly automated systems such as fillers, pick & place robots, cartoners, case packers, labelers, and printers. You will collaborate closely with operations, maintenance, and engineering to prioritize work, reduce downtime, and improve line reliability.
* Continuous Improvement:
Proactively review equipment operation, identify deficiencies, and recommend improvements to increase Overall Equipment Effectiveness (OEE) and support Lean Manufacturing initiatives through leading and supporting key projects.
* Technical Advisory:
Provide input on projects involving parts and material selection, documentation (OJT and SOP creation), testing, problem solving, maintenance requirements, project scope, and follow-up.
* Machine Changeovers:
Provide technical support during machine change-overs for different package sizes and set up packaging lines to ensure smooth startups and increased production efficiency.
* Root Cause Analysis:
Initiate and participate in Root Cause Analysis to address recurring issues and implement effective solutions.
* Training & Compliance:
Provide training related to the maintenance and operation of mechanical and automated equipment, ensuring compliance with company standards, procedures, and government regulations (SOPs, GMPs, etc.).
Required skills, education, and experience:
* Trade certification or degree in engineering, automation, or a related technical field strongly preferred.
* 10+ years of experience in a manufacturing or packaging environment, especially with highly automated pharmaceutical equipment preferred.
* Strong mechanical aptitude and advanced troubleshooting skills.
* Familiarity with Lean Manufacturing principles.
* Understanding of safety, compliance, and regulatory standards in pharmaceutical operations.
* Effective communication and team collaboration skills.
* Ability to stand, walk, bend, and lift for extended periods.
* Comfortable working in a fast-paced, production-driven environment.
* Production Floor presence and support for assigned shift
* Able to perform other duties as required.
Full time
Regular
Colleague
Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.
Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of "@zoetis.com". In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
Auto-ApplyAssociate Process Technician
High Point, NC jobs
Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Your Work Matters.
At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company.
We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters.
Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations.
Together with our customers, we aim to improve the quality of life for patients around the world.
Start a career where You Matter by applying today! Job Overview The Associate Process Technician is an entry level role that will assist with activities in the GMP Kilo and Pilot Plant at Cambrex.
The primary focus will be on supporting Process Technicians and learning from them.
Responsibilities include material handling, equipment maintenance, utilities operations, and providing support for chemical processes.
Responsibilities Basic knowledge of manufacturing equipment operations including batch reactors, filters, dryers and pumps.
Move material between the warehouse and the process suites.
Basic knowledge of equipment and facility maintenance for the GMP and large-scale production areas.
Basic ability to clean equipment and manufacturing facility.
Work with scientific staff to complete chemistry projects.
This position works with and handles hazardous materials and wastes at Cambrex.
This person has the appropriate qualifications to read, understand, apply and communicate written and verbal information regarding handling and managing hazardous wastes.
Training is required within six months of assuming duty and once a year thereafter.
Responsible for recognizing emergency situations concerning hazardous materials and wastes.
Qualifications/Skills Operate Manufacturing Equipment: Gain basic knowledge and assist in the operation of batch reactors, filters, dryers, and pumps.
Material Handling: Move materials between the warehouse and process suites efficiently and safely.
Equipment and Facility Maintenance: Develop basic skills in maintaining equipment and facilities in GMP and large-scale production areas, including cleaning tasks.
Support Chemistry Projects: Collaborate with scientific staff to assist in completing chemistry projects.
Hazardous Materials Management: Handle and manage hazardous materials and wastes, ensuring compliance with safety protocols.
Obtain necessary training within six months of starting and annually thereafter.
Emergency Response: Recognize and respond appropriately to emergency situations involving hazardous materials and wastes.
Education, Experience & Licensing Requirements High School Diploma or equivalent 2 or more years' experience in a chemical manufacturing plant preferred.
Some active work, exerting up to 50 pounds of force occasionally, and/or the amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects.
The daily work is performed is primarily in a production setting.
Walking and standing are required regularly.
Use of ladders and roof access may be required.
Position also requires visual acuity, talking and fingering.
Involves regular use of basic PPE (personal protective equipment) such as supplied air respirator, negative pressure respirator, gloves, safety glasses, shielding clothing.
A Chemical Manufacturing environment.
Basic hazards associated with a small chemical plant environment such as: flammables and/or toxic materials, heavy item movement, large machinery operation.
All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities.
Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.
#LI-RD1High School Diploma or equivalent 2 or more years' experience in a chemical manufacturing plant preferred.
Basic knowledge of manufacturing equipment operations including batch reactors, filters, dryers and pumps.
Move material between the warehouse and the process suites.
Basic knowledge of equipment and facility maintenance for the GMP and large-scale production areas.
Basic ability to clean equipment and manufacturing facility.
Work with scientific staff to complete chemistry projects.
This position works with and handles hazardous materials and wastes at Cambrex.
This person has the appropriate qualifications to read, understand, apply and communicate written and verbal information regarding handling and managing hazardous wastes.
Training is required within six months of assuming duty and once a year thereafter.
Responsible for recognizing emergency situations concerning hazardous materials and wastes.
Auto-ApplyChemical Process Technician
Waltham, MA jobs
Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services.
With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs.
Your Work Matters.
At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company.
We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters.
Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations.
Together with our customers, we aim to improve the quality of life for patients around the world.
Start a career where You Matter by applying today! About Snapdragon Chemistry Snapdragon Chemistry was acquired by Cambrex in 2023 due to its innovative approach to chemical development and is now fully integrated into Cambrex.
As part of our dynamic team, you will have the opportunity to collaborate with world-class leaders in process development and advanced continuous manufacturing technology for traditional small molecules and complex-synthetics.
At Snapdragon Chemistry, we strive to create an environment of innovation and excellence where mutual respect and teamwork underpin our culture.
Job Overview Cambrex Snapdragon Boston is currently seeking exceptional candidates for its Chemical Process Technician position at its Waltham, MA R&D center.
Chemical Process Technicians support manufacturing operations through material handling, equipment cleaning, room cleaning, equipment maintenance, solution preparation, and other process support activities.
This is an hourly full time position with opportunity for overtime.
Some evening or weekend operations may be necessary on occasion.
We are looking for candidates who have a passion for working in a fast-paced, dynamic environment.
The ideal candidate will have an Associate's Degree in with five or more years of relevant experience, or a High School or GED degree with 10 years of experience.
The candidate should enjoy working in the field with their hands.
Responsibilities Work with hazardous materials, including flammable, toxic, and corrosive chemicals, inside of laboratory and warehouse environments Stage, weigh, sample, and transfer materials, including movement of up to 200L drums Maintain manufacturing spaces, chemical storage spaces, and equipment spaces in a state of good operation, including cleaning and organizing reactors and rooms Follow Standard Operating Procedures and Good Documentation Practices in support of cGMP activities, including executing and filling out qualification protocols, calibration protocols, equipment use and care logs Follow required safety protocols, including wearing personal protective equipment, including respirators, steel toed shoes, safety glasses, gloves, and chemical resistant lab coats Other assigned tasks as necessary to support the mission of the company Qualifications/Skills Ability to wear Personal Protective Equipment (PPE), including respirators, steel toed shoes, safety glasses, gloves, and chemical resistant lab coats.
Employee must frequently lift and/or move up to 75 pounds and able to move drums or pallets of up to 600 pounds with use of drum truck or pallet jack.
Ability to occasionally work evenings or weekends, occasionally on short notice.
Ability and demonstrated willingness to comply with, and encourage amongst others, the ethical and cultural standards of Snapdragon Chemistry.
Education, Experience & Licensing Requirements Education: High school or higher degree with 5+ years experience.
Cambrex is committed to providing a safe and productive work environment.
All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen.
The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws.
Refusal to submit to testing will result in disqualification of further employment consideration.
All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities.
Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.
Education: High school or higher degree with 5+ years experience.
Work with hazardous materials, including flammable, toxic, and corrosive chemicals, inside of laboratory and warehouse environments Stage, weigh, sample, and transfer materials, including movement of up to 200L drums Maintain manufacturing spaces, chemical storage spaces, and equipment spaces in a state of good operation, including cleaning and organizing reactors and rooms Follow Standard Operating Procedures and Good Documentation Practices in support of cGMP activities, including executing and filling out qualification protocols, calibration protocols, equipment use and care logs Follow required safety protocols, including wearing personal protective equipment, including respirators, steel toed shoes, safety glasses, gloves, and chemical resistant lab coats Other assigned tasks as necessary to support the mission of the company
Auto-ApplySr Tech Production Set-up and Maintenance (First Shift)
Santa Clara, CA jobs
**About Us:** Cordis is an independent, customer-focused global provider of interventional cardiovascular medical technologies. During our 60+ year history we've established a legacy of pioneering breakthrough technologies, including the first guiding catheters and coronary drug eluting stents. Cordis has built a strong global footprint that spans over 70 countries.
We're teammates, not just employees. Our culture empowers you to act like an owner and unleash your full potential in the process. With diverse teams on a global scale, we foster an inclusive atmosphere where everyone is embraced for who they are, their unique perspective, and what they bring to the table. We believe the richness of our experiences and backgrounds enhances the careers of our teammates, the service to our customers, and ultimately, the lives of our patients.
If you love a challenge and are ready to have a direct, positive impact on the lives of millions, then Cordis is just the place for you. Join us, and let's improve the wellbeing of millions, together.
**We are the people behind the people who keep saving lives.**
The 1 st shift Sr Tech Production Set-up and Maintenance coordinates and perform the calibration and preventative maintenance activities for equipment in the Operations and R&D areas.
**Responsibilities**
+ Perform routine calibration, preventative maintenance, and repair on manufacturing/R&D equipment and systems (including mechanical, pneumatic, and electrical systems).
+ Repair equipment/fixtures as requested by the equipment/fixture owner(s).
+ Possess basic knowledge of a wide range of equipment and the ability to provide technical support to Manufacturing, R&D, and other departments.
+ Ability to review results to ensure that it complies with predetermined requirements/criteria (such as visual, dimensional criteria, etc.).
+ Perform simple calibration activities (as required, with training).
+ Responsible for adhering to all hygiene and safety standards.
+ Responsible for following all company SOPs, cGMPs, WIs, and Quality policies.
+ Work with support groups to troubleshoot and repair equipment.
+ Must be able to work effectively with other department personnel.
+ Responsible for communicating business related issues or opportunities to next management level.
+ Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
+ Responsible for ensuring compliance with Quality Procedures, Laws and Regulations of the applicable markets.
+ Performs other duties assigned as needed.
**Qualifications**
+ High school diploma or equivalent (AA degree preferred) and 5-10years related work experiencerequired.
+ 5+ years working with production related equipment within a Controlled Environment Room (Clean Room) is preferred.
+ Experience or training in hazardous material emergency response is desirable.
+ Experience in a regulated industry where documentation compliance is enforced is preferred.
+ Knowledge of use of hand-tools.
**Pay / Compensation**
The expected pre-tax pay rate for this position is $27.11 - $40.67 per hour
Actual pay may fluctuate outside of the range depending on skills, education, experience, job-related knowledge and location.
Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one's identity. All our teammate's points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.
**JOIN OUR TALENT COMMUNITY**
Joining our Talent Community is a great way to receive company news and updates, as well notifications on career opportunities and events that interest you! Please tell us more about yourself so we can align you with future opportunities that match your background, skills and interests.
**Job Locations** _US-CA-Santa Clara_
**ID** _2025-3504_
**Category** _Operations_
**Position Type** _Regular Full-Time_
CORDIS is proud to be an equal opportunity employer, values diversity in all its forms is and committed to fostering an inclusive work environment. We are committed to advancing our culture of belonging, where all teammates feel seen, heard, and appreciated and encouraged to be their authentic selves. Our team is invested in attracting, retaining and growing top talent. Our Teammates are the core of our innovation and success. Cordis is an inclusive, engaging place to work and grow a career. CORDIS is committed to offering reasonable accommodations, upon request, to job applicants with disabilities. If you need assistance or an accommodation due to a disability, please contact *******************
Formulation Technician III
Madison, WI 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.
The Formulation Technician III mentors others in a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set inclusive of current GMP/ISO requirements and standards and following all safety Guidelines of PCI. With general supervision, the technician performs all manufacturing operations including but not limited to work functions in equipment prep, dispensing, dissolution, formulation, purification, and aseptic compounding activities for biopharma and medical device products. The incumbent must possess the ability to address non routine matters. Utilizes technical knowledge and experience to resolve complex manufacturing problems. Monitors personnel interaction to ensure proper behaviors. Escalates matters requiring resolution by management. Works with Master production records and standard operating procedures. Trains and guides less experienced personnel. Is a model of the Guardian values and behaviors.
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.
Maintains and adheres to safe work habits and all applicable PCI safety procedures and guidelines. Is proactive in identifying safety risks and alerts management to take corrective action
Trains and mentors both peers and less experienced staff in the performance of proper formulation techniques
Has ownership for the daily formulation activities to ensure all scheduled tasks/events are completed
Is responsible for critical steps in the formulation process including but not limited to, lab setup and process flows, in-process testing, API dissolution and final QS while ensuring safety, batch integrity and prevention of errors that could lead to product and or finical loss
Troubleshoots and resolve problems with equipment or processes in the course of performing job duties
Adheres to verbal instructions and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation
Prepares equipment and components for sterilization and Lyophilization
Operates processing equipment including autoclaves, depyrogenation ovens, vial washers, homogenizers, and others
Maintains compliance, cleanliness and orderliness of operational areas per appropriate SOPs
Collaborates with Supervisor and MTS during drafting of new manufacturing batch records and protocols.
Completes Batch Records accurately and completely prior to submission to supervision for review
Complies with all area SOPs and ensure logbooks are completed, and adhere to cGMP requirements
Initiate and support revisions to SOPs and FORMs as needed
Participates in investigations, and contribute to identifying corrective and preventative actions
Cross trains to increase technical skills across the department
Accountable for timely communication to management and clients of issues, challenges as well as opportunities for process improvements
As a member of the manufacturing team, you will perform other manufacturing tasks for example filling, capping etc., as needed
Inspire and constantly strive to make PCI a great place to work and respected for the quality of its people and products and clients
Work with enabling groups to improve/implement processes
Other duties as assigned
Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.
Able to stand for long periods of time, the majority of the work shift
Able to lift 30lbs repeatedly
Able to wear PPE (mask, gloves, respiratory)
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.
Works directly with aseptic and non-aseptic personnel. Works closely with Quality Assurance, MTS, Validation etc.
TRAVEL -
< 10%
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.
High School education, AS degree or BS degree in related field of study is preferred
Experience and knowledge of formulation/compounding tools and equipment
Minimum 4 years formulation/compounding work experience in a GMP environment, preferably in fill finish pharmaceutical operations
Demonstrated ability to prioritize multiple projects and activities
Strong interpersonal skills
Strong working knowledge of MS Office suite is preferable
Strong communication skills
Attention to detail and positive attitude are key attributes
Able to follow rules and regulations perfectly
Resilient as well as flexible
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.
Auto-ApplyFormulation Technician I
Denver, CO jobs
Job Description
This position functions primarily in a classified ISO-8 environment and requires the individual to wear appropriate PPE. This position will perform dispensing and formulation operations and perform other duties, such as cleaning, restocking, visual inspection, and labeling, as required and/or assigned.
All assigned tasks must be conducted in adherence with all applicable procedures, cGMPs, company policies and any other quality or regulatory (Ex: OSHA, DEA, FDA, etc.) requirements. Facility is a multiple shift operation where variable shifts, including weekends, may be required.
Schedule:
Tuesday to Friday
3 PM Until 1:30 AM
(or until work is completed)
Pay: $25/hour
SAFETY
Strictly adhere to all cGMP, health and safety requirements, procedures, and corporate policies.
Authorized to immediately stop any task that is determined to be an imminent hazard.
Always promote and demonstrate safe work practices and adhere to PPE requirements.
Safely handle chemicals, corrosives, solvents, and other pharmaceutical compounds.
Demonstrate physical ability to lift a minimum of 50 lbs. and push/pull pallets, product cans, etc. multiple times per shift.
PRIMARY RESPONSIBILITIES:
Perform ISO-8 dispensing and formulation operations consistent with established protocols, procedures, and regulatory/cGMP requirements.
Learn to utilize all relevant equipment/technology for formulation operations.
Complete and document required training to gain proficiency for all assigned job tasks.
Accurately and contemporaneously document all actions performed per GDP standards.
Assist with classified and non-classified area cleaning and maintenance as required.
Perform visual inspection, labeling, and additional support tasks as required.
Make recommendations for process improvements.
Possess the ability to master multiple processes across different areas.
Recognize and respond appropriately to equipment/documentation issues and deviations; obtain appropriate clarification and guidance from leadership before proceeding.
Maintain a quality focused, “Right First Time”, attitude.
Arrive for work on-time, prepared to work in the classified environment for the majority of each shift.
Operate with Integrity by maintaining high ethical standards. Treat all employees with trust, respect, and professionalism. Speak up and hold others accountable for high integrity by providing constructive feedback. Take accountability for individual and team mistakes and participate in related corrective actions.
Ensure patient safety by understanding you and your team's impact on product quality.
Excel within a diverse and high performing team. Remain open to new ideas and perspectives, communicate across shifts as required, and comply with site process to create a safe work environment.
Demonstrate a passion to perform by meeting personal and departmental goals. Self-driven and self-accountable, performs required tasks, and progresses on qualifications within reasonable timelines.
Demonstrate innovation abilities by identifying and speaking up about viable options for improvements and exploring and creating a path for implementation.
High School Diploma or equivalent.
Must pass a drug test.
Must speak, write, and read English.
Must be a team player.
Must have excellent attention to detail.
Prior Sterile Compounding and Pharmaceutical Industry experience.
Prior experience operating manufacturing equipment/machinery.
Knowledge of FDA guidelines, cGMP, and GDP.
Willingness to participate in training and gain other certifications as needed.
Knowledge of basic arithmetic and chemistry calculations.
Ability to work in a fast-paced environment with dynamic priorities and demands.
Excellent written and verbal communication skills.
Desire to expand knowledge and grow with the company.
Leadership ability.
Formulation Technician I
Denver, CO jobs
Job Description
This position functions primarily in a classified ISO-8 environment and requires the individual to wear appropriate PPE. This position will perform dispensing and formulation operations and perform other duties, such as cleaning, restocking, visual inspection, and labeling, as required and/or assigned.
All assigned tasks must be conducted in adherence with all applicable procedures, cGMPs, company policies and any other quality or regulatory (Ex: OSHA, DEA, FDA, etc.) requirements. Facility is a multiple shift operation where variable shifts, including weekends, may be required.
Schedule:
Monday to Thursday
5 AM until 3:30 PM
(or until work is completed)
Pay: $23/hour
SAFETY
Strictly adhere to all cGMP, health and safety requirements, procedures, and corporate policies.
Authorized to immediately stop any task that is determined to be an imminent hazard.
Always promote and demonstrate safe work practices and adhere to PPE requirements.
Safely handle chemicals, corrosives, solvents, and other pharmaceutical compounds.
Demonstrate physical ability to lift a minimum of 50 lbs. and push/pull pallets, product cans, etc. multiple times per shift.
PRIMARY RESPONSIBILITIES:
Perform ISO-8 dispensing and formulation operations consistent with established protocols, procedures, and regulatory/cGMP requirements.
Learn to utilize all relevant equipment/technology for formulation operations.
Complete and document required training to gain proficiency for all assigned job tasks.
Accurately and contemporaneously document all actions performed per GDP standards.
Assist with classified and non-classified area cleaning and maintenance as required.
Perform visual inspection, labeling, and additional support tasks as required.
Make recommendations for process improvements.
Possess the ability to master multiple processes across different areas.
Recognize and respond appropriately to equipment/documentation issues and deviations; obtain appropriate clarification and guidance from leadership before proceeding.
Maintain a quality focused, “Right First Time”, attitude.
Arrive for work on-time, prepared to work in the classified environment for the majority of each shift.
Operate with Integrity by maintaining high ethical standards. Treat all employees with trust, respect, and professionalism. Speak up and hold others accountable for high integrity by providing constructive feedback. Take accountability for individual and team mistakes and participate in related corrective actions.
Ensure patient safety by understanding you and your team's impact on product quality.
Excel within a diverse and high performing team. Remain open to new ideas and perspectives, communicate across shifts as required, and comply with site process to create a safe work environment.
Demonstrate a passion to perform by meeting personal and departmental goals. Self-driven and self-accountable, performs required tasks, and progresses on qualifications within reasonable timelines.
Demonstrate innovation abilities by identifying and speaking up about viable options for improvements and exploring and creating a path for implementation.
High School Diploma or equivalent.
Must pass a drug test.
Must speak, write, and read English.
Must be a team player.
Must have excellent attention to detail.
Prior Sterile Compounding and Pharmaceutical Industry experience.
Prior experience operating manufacturing equipment/machinery.
Knowledge of FDA guidelines, cGMP, and GDP.
Willingness to participate in training and gain other certifications as needed.
Knowledge of basic arithmetic and chemistry calculations.
Ability to work in a fast-paced environment with dynamic priorities and demands.
Excellent written and verbal communication skills.
Desire to expand knowledge and grow with the company.
Leadership ability.
Manufacturing Engineering Technician
Gardner, MA jobs
Full-time Description
Responsible for contribution to the design of products, production fixtures and methods, and testing solutions. Participation in solving technical problems in design, manufacturing, fabrication, inspection, and maintenance. Assists engineers, inspects products, conducts tests, reworks material, and collects data.
Principal Responsibilities
Act as an engineering resource in transferring new products to manufacturing and sustaining transferred products.
Develop and document assembly, test, and alignment methods; prepare drawings and visual aids; read, follow, critique, and edit work instructions.
Assemble fragile and sensitive electro-mechanical and optical medical devices.
Train manufacturing staff on assembly methods/procedures.
Conduct experiments and record data in a laboratory environment; perform data analysis.
Collaborate directly with engineers, production operators, quality inspectors and management personnel.
Communicate technical issues clearly and effectively to engineering staff.
Establish and maintain stability of late-stage development programs and build activity.
Maintain adequate inventory of all laboratory supplies (e.g., epoxies, Q-tips, etc.).
Understand and comply with the company's quality system; support compliance with FDA QSR, ISO 13485, and other regulatory requirements.
Perform miscellaneous duties and projects as assigned and required.
Requirements
Training, Skills, Knowledge and/or Experience
3 years' experience in a manufacturing, development, or engineering environment with precision devices; background with optics, electronics and/or other small, delicate, or sensitive products.
Strong mechanical and general software aptitude. Ability to quickly learn new technologies and tools.
General understanding of data collection, data reduction, and statistics.
Experience working in FDA QSR and ISO 13485 environments preferred.
Experience interfacing with quality, stockroom, production control, purchasing, and engineering personnel.
Working knowledge of Microsoft 365 apps suite, basic use of ERP/MRP systems.
Education Requirements
High School Diploma or GED required. Associate, two-year technical degree, or equivalent level of education preferred.
Supervisory Responsibility
No supervisory responsibility.
Working Conditions
This job operates in manufacturing and engineering laboratory environments including ISO class 7 cleanrooms.
Physical surroundings
This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets.
PPE required when in controlled environment rooms.
Physical Effort
While performing duties of this job, the employee is regularly required to stand, walk, sit, use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; talk and hear.
Travel
Limited, infrequent travel may be required.
Manufacturing Engineering Technician
Gardner, MA jobs
Job DescriptionDescription:
Responsible for contribution to the design of products, production fixtures and methods, and testing solutions. Participation in solving technical problems in design, manufacturing, fabrication, inspection, and maintenance. Assists engineers, inspects products, conducts tests, reworks material, and collects data.
Principal Responsibilities
Act as an engineering resource in transferring new products to manufacturing and sustaining transferred products.
Develop and document assembly, test, and alignment methods; prepare drawings and visual aids; read, follow, critique, and edit work instructions.
Assemble fragile and sensitive electro-mechanical and optical medical devices.
Train manufacturing staff on assembly methods/procedures.
Conduct experiments and record data in a laboratory environment; perform data analysis.
Collaborate directly with engineers, production operators, quality inspectors and management personnel.
Communicate technical issues clearly and effectively to engineering staff.
Establish and maintain stability of late-stage development programs and build activity.
Maintain adequate inventory of all laboratory supplies (e.g., epoxies, Q-tips, etc.).
Understand and comply with the company's quality system; support compliance with FDA QSR, ISO 13485, and other regulatory requirements.
Perform miscellaneous duties and projects as assigned and required.
Requirements:
Training, Skills, Knowledge and/or Experience
3 years' experience in a manufacturing, development, or engineering environment with precision devices; background with optics, electronics and/or other small, delicate, or sensitive products.
Strong mechanical and general software aptitude. Ability to quickly learn new technologies and tools.
General understanding of data collection, data reduction, and statistics.
Experience working in FDA QSR and ISO 13485 environments preferred.
Experience interfacing with quality, stockroom, production control, purchasing, and engineering personnel.
Working knowledge of Microsoft 365 apps suite, basic use of ERP/MRP systems.
Education Requirements
High School Diploma or GED required. Associate, two-year technical degree, or equivalent level of education preferred.
Supervisory Responsibility
No supervisory responsibility.
Working Conditions
This job operates in manufacturing and engineering laboratory environments including ISO class 7 cleanrooms.
Physical surroundings
This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets.
PPE required when in controlled environment rooms.
Physical Effort
While performing duties of this job, the employee is regularly required to stand, walk, sit, use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; talk and hear.
Travel
Limited, infrequent travel may be required.
Manufacturing Engineering Technician
Westborough, MA jobs
The Panther Group has an immediate need for Manufacturing Engineering Technician. The Manufacturing Engineering Technician is responsible for assisting Manufacturing Engineers in transitioning products from internal and external sources into manufacturing and supporting those products once in routine production under the direction of Manufacturing Engineers.
Duties and Responsibilities
Assist in maintaining and processing changes through an Engineering Change Order (ECO) process for manufacturing files and databases, including Bills of Material, manufacturing assembly and test procedures work instructions, and test records.
With guidance and supervision, provide hands-on troubleshooting and problem solving support within manufacturing as needed.
Make recommendations to Manufacturing Engineering to minimize downtime and improve operational processes.
Collect and track identified information to support Manufacturing Engineering activities including product build and test cycle times, cost reductions and quality improvements.
Assist Manufacturing Engineers with revisions and improvements to manufacturing methods and procedures, including preparing ECOs and deviations.
Assist with hands on training of manufacturing employees on new products, tooling, equipment and process changes/revisions.
Schedule, complete and document routine maintenance on applicable manufacturing build fixtures and test equipment.
With guidance and supervision, participate in building and utilizing assembly and test equipment, including collection of data for analysis with Manufacturing Engineer.
Support Lean Manufacturing and Continuous Improvement activities as directed.
Assist in installation and validation of equipment and processes in the production area as directed.
Comply with policies, guidelines and regulatory requirements per CT's Quality System.
Qualifications
Solid verbal and written skills. Strong problem solving skills.
High school diploma minimum - trade school experience in technology discipline a plus.
Minimum 2 years of experience in a similar/related role within a production environment.
Follow Manufacturing Engineers direction. Cooperative and positive attitude.
Basic computer literacy and working knowledge of MS Office tools.
Experience with MRP/ERP systems a significant plus.
Ability to interpret a bill of material, wiring schematic, assembly drawings desired.
Working knowledge in the use of basic hand tools, screw drivers, torque wrenches, etc.
Working Environment
Generally works in an office environment, but may occasionally be required to perform job duties outside of the typical office setting. Occasional travel.
Pay Rate: $24 to $29 Depending on Experience
#INDENG
IT Manufacturing Engineer
Indianapolis, IN jobs
At Elanco (NYSE: ELAN) - it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals' lives better makes life better - join our team today!
Your Role:
As a IT Manufacturing Engineer at Elanco, you will be a key technical contributor to the digital heart of our production facilities. You will specialize in implementing and supporting our Manufacturing Execution Systems (MES) and Laboratory Execution Systems (LES). This hands-on role is the critical bridge between our physical manufacturing processes and the digital systems that control and document them, ensuring our operations are efficient, compliant, and reliable.
This includes four strategic priorities:
Pipeline Acceleration: Optimize the search and approval of high impact medicines with a focus on speed, cost and precision.
Manufacturing Excellence: Improve the efficiency, quality and consistency of core manufacturing processes, specifically execution and equipment effectiveness.
Sales Effectiveness: Simplify the process to find, trust and consume relevant customer insights that drive sales growth and improved engagement.
Productivity: Expand operating margin through efficiency by systematically reducing our operating expenses across the company, improving profitability.
Your Responsibilities:
System Design and Configuration: Contribute to the design and be responsible for the configuration and implementation of MES/LES solutions. This includes building and modifying electronic batch records (EBRs), system workflows, and configuring equipment integration based on defined requirements.
Process Optimization: Collaborate with operations and quality teams to analyze manufacturing and laboratory workflows. You will use MES/LES capabilities to help implement process improvements, reduce production cycle times, and enhance data integrity at the shop-floor level.
System Management and Support: Provide frontline technical support for MES and LES platforms. You will act as a key technical resource to troubleshoot and resolve system issues, ensuring high availability for our manufacturing and lab teams.
Integration: Assist with the integration between MES/LES and other critical systems, such as our ERP (SAP), LIMS, and shop-floor equipment (PLCs/SCADA), ensuring a reliable flow of data.
Validation and Compliance: Execute validation protocols (IQ/OQ/PQ) for MES/LES enhancements and new implementations. You will be responsible for generating validation documentation and ensuring systems are maintained in a validated state, compliant with GxP and data integrity requirements.
Stakeholder Collaboration: Work closely with Manufacturing Operations, Quality Assurance, and Process Science teams to gather system requirements and provide updates on technical activities.
User Training and Enablement: Develop training materials and conduct training sessions to ensure that manufacturing and lab personnel are proficient in using the MES/LES systems effectively in their day-to-day roles.
What You Need to Succeed (Minimum Qualifications):
Educational Background: A Bachelor's degree in Engineering (e.g., Industrial, Chemical, Manufacturing, Computer Science) or a related technical field.
Required Experience: 3+ years hands-on experience with the configuration, and support of an MES or LES platform (e.g., Werum PAS-X, Emerson Syncade, POMSnet).
Manufacturing Environment Experience: Experience working directly in a manufacturing environment, preferably within the pharmaceutical, biologics, animal health, or another GxP-regulated industry.
Regulatory Knowledge: A working knowledge of GxP (Good Manufacturing Practices) and familiarity with computer system validation (CSV) principles.
Process Control Understanding: Familiarity with industrial automation concepts, including PLCs, SCADA, and how they integrate with higher-level manufacturing systems.
Database and SQL Skills: Experience with SQL for data queries to support troubleshooting, data extraction, and report generation.
What Will Give You the Competitive Edge (Preferred Qualifications):
Problem-Solving: Strong analytical and troubleshooting skills, with the ability to systematically diagnose and resolve technical issues.
Process Analysis: A solid understanding of business process analysis and workflow design. Ability to read and interpret process maps and requirements documents.
Cross-Functional Collaboration: Good communication and interpersonal skills, with a proven ability to work effectively in a team environment with operators, scientists, and management.
Cloud Platform Proficiency: Familiarity with Public Cloud platforms, specifically Microsoft Azure or Google Cloud Platform (GCP), is a plus.
DevSecOps: Familiarity with the concepts of DevSecOps, including Continuous Integration/Continuous Delivery (CI/CD) and source control (Git), is desirable.
Communication Skills: Good verbal and written communication skills, with the ability to collaborate effectively within a technical team.
Additional Information:
Location: Global Headquarters- Indianapolis, IN (Hybrid environment)
Travel: Minimal
Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
Multiple relocation packages
Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
8-week parental leave
9 Employee Resource Groups
Annual bonus offering
Flexible work arrangements
Up to 6% 401K matching
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
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