Manufacturing Project Engineer
Process engineer job in Holly Springs, NC
Position involves support of senior staff in the initiation, design, and delivery of manufacturing projects, particularly for facilities-related scope. Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution by third party firms. Assist with project definition by performing engineering studies and assessment for facilities system, perform quality and overall facilities walkdowns. Perform field evaluations of existing systems and provide engineering design recommendations.
Responsibilities
Provide support to Facilities Senior Manager on various ongoing activities, including new projects
Accountable for walkdowns and punch list resolution
Daily responsibilities will vary based on the need of the business; it can be from maintenance operation to punch lists resolution.
Required Skills
self-starter
Ability to communicate effectively
Ability to manage tasks to completion
Experience with facilities management and projects in a biotech/pharmaceutical manufacturing environment is a must
Preferred Skills
Masters degree
OR
Bachelors degree and 2 years of experience
OR
Associates degree and 6 years of experience
OR
High school diploma / GED and 8 years of experience
Packaging Engineer
Process engineer job in Sanford, NC
Responsibilities:
* Proper packaging design includes part containment, protection, and optimization of transportation and other supply network functions.
* Provide NPI support to Engineering, Manufacturing, Logistics, and Part Suppliers in developing packaging solutions to machine components.
* Design for transport efficiency.
* Validate new packaging and containers during pilot phase.
* Coordinate with assembly planning for line-side storage and ergonomic considerations.
* Develop kitting/ sequencing packaging for in-plant use.
* Resolve safety and / or quality issues caused by current packaging.
* Perform containerization analysis and quoting as required.
* Manage repair/maintenance of Returnable Packaging.
* Research and analyze supplier design proposals, specifications, drawings to determine time and cost feasibility to complete projects.
* Communicate with existing facilities on packaging issues related to receiving, warehousing, and/or line side delivery.
* Lead medium to high risk Green Belt projects with product and logistics groups
* Hours will depend on business need
* 2 rounds of interviews expected
* Can work 4 or 5-day work schedule
* Packaging design or project management experience desired
Education & Experience Required:
* Education Requirements: Bachelor's in Packaging Engineering degree preferred, Mechanical, Industrial, and Supply Chain Engineer degrees will be accepted.
* 2+ years
Technical Skills
* **Technical Skills:
* Top Skills:
* 3D modeling or Creo experience
* Proficiency in MS Office and Modeling Software
* Advanced packaging / transportation experience Desired skills: Commensurate Project management experience
Product Quality Engineer
Process engineer job in Parkton, NC
The application window is expected to close on: 12/05/2025 Job posting may be removed earlier if the position is filled or if a sufficient number of applications are received. Members of the Supply Chain organization at select locations will generally be expected to follow a hybrid work model, which includes two days of in-office attendance each week, with limited exceptions.
What You'll Do
You are an advocate for New Product Introduction Quality and Field Quality across assigned product families, driving detailed quality improvements efforts through collaborative engagement with internal and external partners. You ensure New Product Introductions meet quality requirements through phase gate reviews. Your curiosity leads you to conduct data analysis deep dives, seeking to identify trends in field reliability performance, identify units for failure analysis, and coalesce data insights and visualization to assist engineering with the pursuit of root cause(s) and solutions to design and/or process solutions. In the pursuit of customer satisfaction, you continue to work with partnering organizations to implement product improvements that enhance field reliability and robustness. As the quality representative on critical issue teams, you assist in the management and closure of factory or field escalations. You can identify key lessons-learned and work to propagate known solutions across the existing product portfolio as well as into new product development with the goal of eliminating repeat occurrences. You ensure that Ongoing Reliability Testing (ORT) data is reviewed and compared to field trends, and you assist in managing factory yield performance in concert with Manufacturing Engineering and Operations team members to facilitate improvements as required to meet baseline quality metrics.
Who You'll Work With
You will work with the New Product Introduction Team such as Development Engineers, Manufacturing Engineers and Manufacturing partners to ensure assigned product families meet or exceed the target quality and reliability requirements and performance metrics that are committed to the business. You will have the ability to inspire change and improve product quality in collaboration with a diverse multi-functional team while making a difference to Cisco's customers.
Who You Are
You excel at data analytics and can transform and model data with the goal of discovering useful information, suggesting conclusions, and supporting decision-making. You have good knowledge and understand how to measure and improve quality. You can lead individuals and teams to determine root cause of field failures. You can distill technical risk and provide an assessment and recommended path forward to maintain customer satisfaction and the quality of the Cisco brand. You can also determine if appropriate screens or containment actions should be implemented based on failure mechanism and data analysis until such time that long term corrective action(s) are put in place. You can prepare technical reports, summarize key take-aways, and communicate overall quality status with appropriate Quality, Manufacturing, Business Ops and Engineering teams in an effective manner. You are experienced with change implementation, qualifications, and product or process transitions. You help the organization develop and promote proactive culture to meet internal and external customer requirements. You work well with functional groups at all levels to address and resolve critical product and customer issues.
Minimum Requirements:
* Bachelor of Science degree from an accredited university in Engineering (Electrical, Mechanical, or Industrial) with a minimum of 5 years relevant experience in a related industry is required. Alternatively, a Master's degree with a minimum of 3 years of relevant experience will be considered.
* Engineering principles of electronics, mechanics, knowledge of product design, manufacturing and test process technologies used in the development and production of advanced electronic hardware.
* Advanced data analysis & visualization. Must be capable of managing large, multi-variate data sets, and trend analysis
Preferred Qualifications:
* Excellent problem-solving skills, including working knowledge and experience applying 8D Issue Resolution Process methodologies.
* Extensive experience driving detailed quality improvements, while engaging collaboratively with both internal key stakeholders as well as external customers and partners.
* Demonstrated ability to work cross-functionally with Manufacturing Operations, Assembly Process, Test Process, and Hardware Engineering teams to analyze yield loss and develop solutions for yield improvement, validating all solutions prior to implementation into the factory environment.
* Six Sigma Green Belt certification is preferred.
* Certified Quality Engineer certification (ASQ) is highly desired.
* Must be well versed with all Microsoft office applications. A high level of Excel proficiency is required.
* Experience with Mini-tab, JMP, Spotfire and Tableau is highly desired.
* Excellent interpersonal skills in all forms - written & verbal communications, ability to understand your audience and present technical content to non-technical and technical team members as well as company leadership.
* Ability to propose innovative approaches, tackle transformation of legacy business processes, negotiate and influence outcomes.
* Good knowledge of data analytics tools. While this position is largely focused on the quality performance of hardware platforms, a knowledge of software quality is very helpful. Familiarity with Agile methodologies and business process automation is preferred
**Why Cisco?**
At Cisco, we're revolutionizing how data and infrastructure connect and protect organizations in the AI era - and beyond. We've been innovating fearlessly for 40 years to create solutions that power how humans and technology work together across the physical and digital worlds. These solutions provide customers with unparalleled security, visibility, and insights across the entire digital footprint.
Fueled by the depth and breadth of our technology, we experiment and create meaningful solutions. Add to that our worldwide network of doers and experts, and you'll see that the opportunities to grow and build are limitless. We work as a team, collaborating with empathy to make really big things happen on a global scale. Because our solutions are everywhere, our impact is everywhere.
We are Cisco, and our power starts with you.
**Message to applicants applying to work in the U.S. and/or Canada:**
The starting salary range posted for this position is $122,200.00 to $154,700.00 and reflects the projected salary range for new hires in this position in U.S. and/or Canada locations, not including incentive compensation*, equity, or benefits.
Individual pay is determined by the candidate's hiring location, market conditions, job-related skillset, experience, qualifications, education, certifications, and/or training. The full salary range for certain locations is listed below. For locations not listed below, the recruiter can share more details about compensation for the role in your location during the hiring process.
U.S. employees are offered benefits, subject to Cisco's plan eligibility rules, which include medical, dental and vision insurance, a 401(k) plan with a Cisco matching contribution, paid parental leave, short and long-term disability coverage, and basic life insurance. Please see the Cisco careers site to discover more benefits and perks. Employees may be eligible to receive grants of Cisco restricted stock units, which vest following continued employment with Cisco for defined periods of time.
U.S. employees are eligible for paid time away as described below, subject to Cisco's policies:
+ 10 paid holidays per full calendar year, plus 1 floating holiday for non-exempt employees
+ 1 paid day off for employee's birthday, paid year-end holiday shutdown, and 4 paid days off for personal wellness determined by Cisco
+ Non-exempt employees** receive 16 days of paid vacation time per full calendar year, accrued at rate of 4.92 hours per pay period for full-time employees
+ Exempt employees participate in Cisco's flexible vacation time off program, which has no defined limit on how much vacation time eligible employees may use (subject to availability and some business limitations)
+ 80 hours of sick time off provided on hire date and each January 1st thereafter, and up to 80 hours of unused sick time carried forward from one calendar year to the next
+ Additional paid time away may be requested to deal with critical or emergency issues for family members
+ Optional 10 paid days per full calendar year to volunteer
For non-sales roles, employees are also eligible to earn annual bonuses subject to Cisco's policies.
Employees on sales plans earn performance-based incentive pay on top of their base salary, which is split between quota and non-quota components, subject to the applicable Cisco plan. For quota-based incentive pay, Cisco typically pays as follows:
+ .75% of incentive target for each 1% of revenue attainment up to 50% of quota;
+ 1.5% of incentive target for each 1% of attainment between 50% and 75%;
+ 1% of incentive target for each 1% of attainment between 75% and 100%; and
+ Once performance exceeds 100% attainment, incentive rates are at or above 1% for each 1% of attainment with no cap on incentive compensation.
For non-quota-based sales performance elements such as strategic sales objectives, Cisco may pay 0% up to 125% of target. Cisco sales plans do not have a minimum threshold of performance for sales incentive compensation to be paid.
The applicable full salary ranges for this position, by specific state, are listed below:
New York City Metro Area:
$122,200.00 - $177,900.00
Non-Metro New York state & Washington state:
$108,700.00 - $158,400.00
* For quota-based sales roles on Cisco's sales plan, the ranges provided in this posting include base pay and sales target incentive compensation combined.
** Employees in Illinois, whether exempt or non-exempt, will participate in a unique time off program to meet local requirements.
Cisco is an Affirmative Action and Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, genetic information, age, disability, veteran status, or any other legally protected basis.
Cisco will consider for employment, on a case by case basis, qualified applicants with arrest and conviction records.
Process Engineer
Process engineer job in Holly Springs, NC
Full-time Description
ValSource is currently looking to identify experienced and technically skilled leaders in Process/Process Equipment Engineering to support exciting GMP Drug Substance and Drug Product capital projects throughout our network. This is a key part of strengthening ValSource's role in front-end Engineering and enabling end-to-end support for our clients.
Responsibilities
We are seeking passionate, energetic leaders with strong initiative to support our clients' Process Engineering programs within Pharmaceutical and Biotech GMP manufacturing facilities. This includes systems and equipment used in these environments.
Responsibilities include, but are not limited to:
Reporting to the clients Process Engineering or Area Manager, while demonstrating independent drive and sound judgment in day-to-day operations at the client site.
Collaborating closely with client teams and internal staff to act in the best interest of the client.
Lead the project through an offsite design effort (at the Design partner's location), to onsite installation and execution at the Client site.
Manage multidisciplinary teams with representatives from Process Engineering, Automation, Commissioning, Qualification & Validation (CQV) and others to drive projects through capital management phases from Concept Design, through Detailed Design and Execution.
Provide clear technical leadership and expertise to lead teams through Safety assessments (PHA, HAZOP and LOPA) and Quality assessments (Development of CIP/SIP strategy, Automation development and GMP Design review). Gather internal and external stakeholder requirements and communicate clear owner's intent, ensure stakeholders are aligned or if not, escalate issues for rapid decision making.
Collaborate strongly with client Subject Matter Experts (SMEs) for critical design decisions.
·Demonstrate strong organization, technical writing and communication skills. Coordinate succinctly and effectively with the management and reporting team to drive clear and timely decision making.
Manage quality, schedule and cost within prescribed project limits.
Ensure the thorough completion of the following process-specific activities:
Vendor collaboration: build productive relationships to deliver complex equipment in a timely manner.
Listen and translate clients' operational requirements to a hard design; document these needs in User Requirements and Equipment Specifications to onboard a Vendor.
Review vendor design specifications and submittals to ensure compliance with client requirements and industry best practices in the physical design.
Ensure clear communication and prioritization of needs for Structural, Civil, HVAC, Electrical & Construction groups.
Lead FAT execution at Vendor sites, representing the client. Act as facilitator, supervisor and Safety lead ensuring client Safety and Quality standards are upheld.
Lead and oversee Execution phase for the Process Team with CQV team, ensuring thorough testing of all requirements and demonstration of system functionality.
Requirements
Location: Conshohocken, PA & Holly Springs, NC
Project Duration: Through Performance Qualification (PQ) Phase
Travel: Required between Conshohocken, PA and Holly Springs, NC
We are seeking several experienced Process / Process Equipment Engineers to support a major pharmaceutical manufacturing project. These individuals will act as Owner's Representatives throughout the full project lifecycle-from design and installation through commissioning, qualification, and startup.
Initial project work will be located in
Conshohocken, PA
(suburb of Philadelphia) for 6-12 months with an eventual transition to on-site in
Holly Springs, NC
for 2+ years.
Key Responsibilities
Project Oversight & Support
Serve as Owner's Representatives for the following areas:
Compounding/Formulation Systems
Component and Stopper Preparation (washers, autoclaves, stopper processors)
Syringe Filling Equipment
Automated Visual Inspection Systems
Autoinjector Assembly Equipment
Secondary Packaging Lines
Leadership & Collaboration
Lead cross-functional teams across engineering, quality, validation, and operations.
Collaborate with Jacobs project teams and internal stakeholders to ensure alignment of design, installation, and qualification with Owner's requirements.
Bring in internal SMEs as needed to address specialized technical issues.
Alignment & Communication
Proactively gather and clarify stakeholder requirements.
Clearly communicate Owner's intent to project teams.
Facilitate alignment across disciplines; escalate unresolved issues for timely resolution.
Execution & Accountability
Ensure all assigned equipment areas meet project safety, quality, schedule, and cost targets.
Drive results-anticipate challenges, resolve issues independently, and ensure discipline deliverables are achieved in full, on time, and on budget.
Take ownership and accountability for area performance through all project phases.
Candidate Qualifications:
Bachelor's degree in engineering or related field.
Minimum of 6-8+ years of experience in pharmaceutical or biotech manufacturing projects.
Strong working knowledge of GMP systems, equipment qualification, and process operations.
Proven ability to lead teams, manage stakeholders, and drive performance across disciplines.
Excellent communication, problem-solving, and organizational skills.
Willingness to travel and spend time at both Conshohocken and Holly Springs locations.
Other information
This is a full-time position with ValSource. As such, we are not considering applications from employment agencies, independent contractors, or third-party vendors.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
Benefits
Benefits of full-time employment with ValSource will include:
Paid Time Off (PTO) and Holidays
Medical / Dental / Vision Insurance - premiums 100% paid by ValSource for Employee to Family level coverage
Basic Life / Short- and Long-Term Disability / Voluntary Life / AD&D Insurance coverages
ValSource 401(k) Plan
ValSource Employee Stock Ownership Plan (ESOP)
Paid Maternity / Paternity
Medical Leave Pay
Tuition Reimbursement / Continuing Education
Annual Performance Bonus Compensation
About ValSource
ValSource is one of the largest independent Validation Services Company in North America with over 350 Engineering, Commissioning, Qualification and Validation employees. ValSource returns validation to a scientific event which helps companies design, perform and better control manufacturing processes throughout all stages of the operations life cycle. Full-time employees are offered a competitive compensation package that also includes full benefits (medical, dental, vision, short- and long-term disability), 401k, paid time off (holidays and vacation), continuous training and development, Employee Stock Ownership Plan, discretionary bonus, etc.
Equal Employment Opportunity
ValSource provides equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, genetic information, military, and veteran status.
Salary Description $65.00 - $75.00/hour
Process Engineer
Process engineer job in Sanford, NC
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** .
**Purpose and Scope:**
The Process Engineer is responsible for providing technical support to help ensure the successful deployment of new equipment, single-use systems, and processes; support and troubleshoot existing equipment and systems for pre-clinical through commercial manufacturing processes for drug substance; and assist in the technical transfer of processes from small/lab scale to large/commercial scale and from external partners. The role is also responsible for effective collaboration with Manufacturing, Automation, Supply Chain, Warehouse, Technical Development, Quality, Regulatory, Facilities, Validation, and various vendors. This role is based in Sanford, NC.
**Essential Job Responsibilities:**
+ Provide process engineering, design, and on-going improvements for drug substance manufacturing processes
+ Process subject matter expert in either upstream or downstream drug substance manufacturing with ability to support multiple modalities
+ Matrix leadership of cross-functional teams to define and implement a robust process control strategy commensurate with program phase from pre-clinical through commercialization
+ Support Single-Use (SU) program development and execution and consumable design and material qualification in collaboration with internal and external partners
+ Evaluate new technologies that will enhance control of production processes and help coordinate deployment across the manufacturing network as appropriate and
+ Interact closely with vendors for SU materials and equipment procurement, as well as new technology implementation
+ Routine trending of process data to enhance process understanding, proactively identify gaps and issues, and implement process improvements
+ Author and review process descriptions, standard operating procedures, technical reports, risk assessments, campaign summary reports, health authority briefing documents, submissions, and responses, tech transfer plans/reports, PPQ protocols/reports, process control strategy, and engineering study protocols/reports
+ Support/lead tech transfer, equipment commissioning, training, and validation activities
+ Provide on-the-floor support to implement improvements for process, equipment, or operational procedures including evaluation and testing of new technologies, new operating strategies, and process and equipment troubleshooting for GMP manufacturing
+ Support recipe generation and updates for process equipment such as bioreactors, chromatography systems, and TFF systems
+ Support process deviation investigations, root cause analysis, and CAPAs
+ Support product lifecycle management that incorporates phase appropriate requirements and expectations from pre-clinical through commercialization and drives process optimization and cost of goods reduction
+ Will support and demonstrate data integrity standards to ensure data of highest quality
**Qualifications**
**Required:**
+ MS in Engineering or Life Sciences, entry level, or BS with 2 years of relevant technical experience.
+ Sound technical knowledge of upstream or downstream bioprocessing with a background in biologic or ATMP process development, technical transfer, and/or manufacturing
+ Must be highly self-motivated, with solid communication skills, and demonstrate the ability to work in a team environment and lead other professionals and peers
+ Ability to think critically, and demonstrated troubleshooting and problem-solving skills
+ Demonstrated experience with interpreting complex data sets
+ Effective scientific communication skills, including technical writing and presentation of technical content to diverse audiences
+ Capable of working independently with minimal supervision
+ Desire to work within a fast-paced environment under challenging timelines
+ Attention to detail supported by good time management and organizational skills
+ Proficiency with MS Office (Excel, PowerPoint, Word, Project, and Visio)
**Preferred:**
+ Experience in gene therapy and/or monoclonal antibody manufacturing, scale-up/scale-down, and tech transfer
+ Understanding of industry expectations with respect to phase appropriate requirements while advancing products from pre-clinical to commercial state
+ Experience with statistical analysis and associated software (e.g., JMP)
+ Experience with single-use equipment and systems
+ Knowledge of cGMPs and good documentation practices (GDP)
+ Experience with process equipment and facility design engineering such as hydraulic calculations, equipment sizing, process simulations, Heat and Material Balances (H&MB), Process Flow Diagrams (PFDs), Piping and Instrumentation Diagrams (P&IDs), and User Requirement Specification (URS) development
+ Experience with process validation and lifecycle management
+ Experience supporting commissioning and qualification-related activities such as FAT, SAT, and IQ/OQ
**Working Environment:**
+ This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs.
+ As assigned, this position may be required to work during non-traditional work hours to support critical business operations
+ This is an on-site role working in a cGMP regulated manufacturing facility with some hybrid flexibility
+ On occasion, this role may travel to other Astellas sites and/or vendors (0-5%)
**Salary Range** : $91,000-$143,000 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)
**Benefits** :
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Company fleet vehicle for eligible positions
+ Referral bonus program
**\#LI-TR1**
Category Sanford TC
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
Associate Engineer, Process Development - Downstream
Process engineer job in Holly Springs, NC
**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. The Amgen FleX batch facility combines the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility not only features the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities but also integrates sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
**Associate Engineer, Process Development**
**What you will do**
Let's do this. Let's change the world. In this vital role you will be a part of the Process Development Drug Substance Technology group at Amgen's FleX Batch Biologics Manufacturing Facility. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes collaborating with other drug substance teams across our network. Additionally, the Process Development Associate will use out-of-the-box thinking to contribute to technology development and will demonstrate the desire to expand and develop expertise in downstream protein purification, thereby further contributing to the integrated group.
+ Apply a fundamental understanding of Downstream (Purification) Bioprocessing to support biologics technology transfer, process validation, and plant start-up
+ Support continuous process verification, process monitoring, optimization, complex investigation, and product life cycle management
+ Ensure safety and compliance of process development activities
+ Provide process on floor process support as required
+ Provide support for regulatory filing, inspection, and other CMC activities
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek is a leader with these qualifications.
**Basic Qualifications:**
+ High school diploma / GED and 6 years of Chemical, Biomedical, or related Engineering; Life Sciences; or other relevant sciences' experience OR
+ Associates and 4 years of Chemical, Biomedical, or related Engineering; Life Sciences; or other relevant sciences' experience OR
+ Bachelor's degree
**Preferred Qualifications:**
+ Master's degree in Chemical, Biomedical, or related Engineering; Life Sciences; or other relevant sciences
+ Some experience in a technical role supporting biotechnology processes within regulated environments (i.e., cGMP)
+ Understanding of protein purification/separation principles
+ Understanding of process scale-up, technology transfer, troubleshooting, and complex investigation
+ Strong oral and verbal communication skills, interact effectively with diverse internal and external stakeholders
+ Familiarity in statistical analysis, analytical methods, and product quality attributes related to biological processing
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Process Engineer- Personal Care
Process engineer job in Raeford, NC
Background & Purpose of the Job The Process Engineer role is critical to the development of our factories to World Class, which means zero defects, zero waste and zero losses. She/he will apply extensively the full range of Focused Improvement methods and tools to counter losses identified in the areas of Safety, Quality, Cost Deployment, Customer Service and Logistics. The Cost Deployment pillar will be populated with data built up through application of the Managing Manufacturing Performance Code, which is key to ensuring focus on key losses. Working directly with the line crews on a daily basis the Process Engineer also acts as a trainer for line teams and provides coaching in phenomena identification, root cause analysis and the establishment of countermeasures. The Process Engineer is responsible for the validation of all process improvements and the establishment of revised basic conditions on the line. A core deliverable is eliminating losses and wastes and increase the stability of the line to support the transition of traditional line teams to semi-autonomous teams.
Who You Are & What You'll Do
* You're a born leader: Taking responsibility for building your team's performance and sharing your best interventions to help support other lines in their improvements.
* You're a strategy guru: Leverage technical knowledge and a systems approach to ensure factory lines and processes are optimally resourced
* You're a dot connector: Collect and analyze complex data to penetrate problems' phenomena and understand root causes
* You love to win and have fun doing it: By building world class factories we will become more competitive in the marketplace and set the standards to which others aspire.
* You're a storyteller: By providing consistent and near real time information, decisions can be taken quickly which leverage our resources.
* You're a changemaker: Apply the continuous improvement mindset and utilize tools to identify root causes, define countermeasures and validate their effectiveness; mastery of AM, PM, Q and FI tools and processes. Establish standards to support line operators sustain new basic conditions
What You'll Need To Succeed
Experience in statistics and process control tools.
Experience in AM, PM, Quality and FI tools and processes.
Minimum 3 years of experience in a manufacturing environment (FMCG preferred)
Six Sigma Certification (Preferred)
Confident in applying problem solving tools (5W1H, 4M, 5WHY etc.)
What We Can Offer You
Culture for Growth | Top Notch Employee Health & Well Being Benefits | Every Voice Matters | Global Reach | Life at Unilever | Careers with Purpose | World Class Career Development Programs | Check Out Our Space | Focus On Sustainability
Pay: The pay range for this position is $69,360 to $104,040. Unilever takes into consideration a wide range of factors that are utilized in making compensation decisions including, but not limited to, skill sets, experience and training, licensure and certifications, qualifications and education, and other business and organizational needs.
Bonus: This position is bonus eligible.
Long-Term Incentive (LTI): This position is LTI eligible.
Benefits: Unilever employees are eligible to participate in our benefits plan. Should the employee choose to participate, they can choose from a range of benefits to include, but is not limited to, health insurance (including prescription drug, dental, and vision coverage), retirement savings benefits, life insurance and disability benefits, parental leave, sick leave, paid vacation and holidays, as well as access to numerous voluntary benefits. Any coverages for health insurance and retirement benefits will be in accordance with the terms and conditions of the applicable plans and associated governing plan documents.
* -----------------------------------
At Unilever, inclusion is at the heart of everything we do. We welcome applicants from all walks of life and are committed to creating an environment where everyone can thrive/succeed. All applicants will receive fair and respectful consideration, and we actively support the growth and development of every employee.
Unilever is an Equal Opportunity Employer/Protected Veterans/Persons with Disabilities.
For more information on your federal rights, please see Know Your Rights: Workplace Discrimination is Illegal
Employment is subject to verification of pre-screening tests, which may include drug screening, background check, credit check and DMV check.
If you are an individual with a disability in need of assistance at any time during our recruitment process, please contact us at NA.Accommodations@unilever.com. Please note: This email is reserved for individuals with disabilities in need of assistance and is not a means of inquiry about positions or application statuses. The Protected Veterans or Individuals with Disabilities AAP narratives are available for inspection by any employee or applicant for employment Monday through Friday during normal business hours at establishment.
Auto-ApplyProcess Engineer, Biotech Process Equipment Owner - (JP14141)
Process engineer job in Holly Springs, NC
Employment Type: Contract Business Unit: ANC Engineering & Automation Duration: 3 years with likely extensions and/or conversion to permanent Number of openings: 3
Posting Date: 06/04/2025
Pay Rate: $32 - $38/hour
Notes: Standard business hours (~8 to 5) with flexibility for: Evening or weekend work, Occasional holiday support, Up to ~50 hours/week, assuming occasional OT
3 Key Consulting is hiring Process Engineers for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Ideal candidate is a commercially experienced Process Engineer with a BS in Chemical, Mechanical, or Biomedical Engineering, who has supported large-scale drug substance operations in biotech or pharma. They are hands-on with equipment ownership (not maintenance) and are highly adaptable, collaborative, and proactive. The ideal candidate embraces ambiguity, is passionate about solving complex operational problems, and thrives in a startup-like GMP environment where they can wear multiple hats, support dynamic business needs, and help drive continuous improvement initiatives. Recruiters expected to pre-screen thoroughly and look for tangible examples of initiative and project ownership. Ideal resumes will show practical accomplishments and clearly demonstrate team-based, cross-functional efforts
Not a maintenance role:
They design/own the equipment and support proper maintenance planning, not execution.
This opportunity is based at a brand-new, advanced biologics manufacturing plant. The site features a cutting-edge FleX Batch facility that combines the latest in disposable technologies with traditional stainless-steel systems, enabling maximum operational flexibility. The facility integrates best-in-class manufacturing processes and industry 4.0 capabilities, along with sustainability initiatives designed to reduce carbon emissions and waste.
Top Must Have Skills:
Experience working in commercial biotech manufacturing industry.
Strong drive and proven results in solving complex and ambiguous problems.
Demonstrated ability to work well in highly collaborative environments.
Responsibilities:
In this role, the Engineer will report to the Senior Manager of the Process Engineering group and will provide daily engineering support to the site. Responsibilities include:
Serve as system owner for process equipment and systems supporting manufacturing operations.
Provide engineering support for design, construction, startup, commissioning, and qualification of new or modified systems.
Identify and/or lead implementation of small-to-medium scale equipment or facility improvements, including development of business cases.
Develop maintenance programs, ensure spare part availability, and coordinate execution to maintain system reliability.
Ensure systems operate safely and in compliance with EHS standards and regulations.
Support commissioning and qualification activities in alignment with GMP requirements and regulatory inspections.
Apply engineering principles in daily operations, maintenance, and troubleshooting of plant systems.
Monitor system performance and implement risk-reduction strategies.
Lead or support troubleshooting efforts to minimize production downtime, including root cause analysis and CAPA implementation.
Support new product and technology introductions via engineering assessments, equipment modifications, and pilot runs.
Advance use of predictive maintenance and condition-based monitoring using data analytics where applicable.
Lead or contribute to deviation investigations and other quality-related processes.
Analyze and present findings related to operational issues and engineering projects.
Provide technical support to commercial and clinical manufacturing, specifically in process control and equipment.
Collaborate with cross-functional groups such as manufacturing, process development, utilities, maintenance, quality, and validation to drive operational improvements.
Maintain regular communication with leadership and team members, escalating issues with proposed solutions.
Participate in a small engineering team on a project or ongoing support basis.
Provide rotational on-call support for utility systems, including nights, weekends, and holidays as needed.
Participate in the design and selection of systems, instrumentation, and components.
Evaluate supplier capabilities and assess new technologies to improve cost, throughput, or technical capabilities.
Preferred Qualifications:
Bachelor's degree in Chemical or Mechanical Engineering.
3+ years of relevant work experience, including 2+ years in a biopharmaceutical manufacturing environment.
Hands-on experience with GMP production equipment such as bioreactors, centrifuges, filtration systems, and purification technologies.
Proficiency with equipment and facility control systems, including troubleshooting and logic understanding.
Experience in regulated environments (e.g., cGMP, OSHA, EPA) and knowledge of quality systems (e.g., change control, non-conformances, CAPA, validation).
Strong communication, technical writing, and presentation skills; ability to work independently.
Proven team collaboration and facilitation skills.
Analytical thinking with the ability to interpret complex problems using multiple data sources.
Ability to support capital projects and implement process improvements.
Understanding of capital project execution from procurement through validation in GMP environments.
Commitment to safety and compliance in all engineering activities.
Self-starter with excellent organization, time management, and multitasking skills.
Willingness to work flexible hours in support of 24/7 manufacturing operations.
Why is the Position Open?
Additional team member
Red Flags:
Gaps in employment without clear justification
Not a maintenance role: They design/own the equipment and support proper maintenance planning, not execution.
Not a research role. Candidates with advanced degrees seeking research roles should not be submitted.
Lack of biotech experience.
Lack of desired degree (Chemical, Mechanical, or Biomedical Engineering).
Rigid personalities or candidates uncomfortable with ambiguity or startup-like agility
Interview process:
Manager Phone Screening followed by interview panels and post panels follow-up meeting with hiring manager.
We invite qualified candidates to send your resume to **************************. If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website ******************************* You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Regards, 3KC Talent Acquisition Team
Easy ApplyIndustrial Engineer
Process engineer job in Raeford, NC
Job DescriptionDescription:
The Industrial Engineer will find ways to prevent waste and inefficiency in production processes. They will design efficient systems that integrate workers, information, machines, energy and materials to make products ro provide services. The Industrial Engineer will also design equipment to coordinate production planning and to issues and costs while ensuring products meet quality standards. They wil design, develop and maintain manufacturing routes to maximize effectiveness, efficiency and space. The Industrial Engineer will also make sure that he company complies with all industry standards for safety while meeting design standards and guidelines. They will also work in a support role as needed on less complex projects.
PRIMARY RESPONSIBILITIES
The Industrial Engineer has responsibility to support, improve, implement and evaluate processes based on requirements by management. Specific responsibilities include, but are limited to the following:
Review production information to understand methods and activities in manufacturing and services. This includes, but is not limited to, production schedules, process flows and engineering specs.
Design control systems to minimize and resolve production issues and project costs
Create systems and plan production to ensure all products meet quality control standards
Develop standards for production and design by working with clients and management.
Requirements:
KNOWLEDGE AND SKILLS
Knowledge of production processes, costs, quality control, raw materials and other methods for maximizing the efficient manufacture and distribution of goods.
Advanced knowledge of machines and tools, their designs, uses, repair and maintenance.
Ability to design and understand precision technical plans, blueprints, drawings and models.
Knowledge of the ways various systems interact and how changes in operations, the environment and other conditions will affect outcomes.
Assignment complexity-Generally works on simple to moderately complex work assignments. Articulates in analyzing potential problems, provides options and implements agreed solutions.
Accountability-Works under limited supervision with freedom to act within the guidelines of his responsibilities.
Impact of Decisions- Has contributory or shared decision impact. Erroneous decisions may have limited effect on results.
PHYSICAL JOB DEMANDS
Ability to lift 60 lbs., work in extreme hot and cold weather, must stand for long periods of time, will be exposed to loud noise levels, operate hand and power tools for long periods of time. Work in an environment with dirt, grease and dust.
WORKING CONDITIONS
Monday through Friday and on call is required. Shift, week-end and overtime as required.
SAFETY
Takes appropriate measures to ensure safety in the work place; attends monthly safety meetings as required, and for new employees and incorporates various principles into daily work activities to ensure compliance; notifies manager immediately (within 24 hours) of work place injury and ensures appropriate policies and procedures are followed; reports potential safety hazards immediately to manager.
DISCLAIMER CLAUSE
The above statements are intended to describe the general nature and level of the work being performed by the employee assigned to this position. They are not exhaustive lists of all duties and responsibilities, knowledge, skills, abilities, physical job demands and working conditions associated with the position.
Hot End Process Engineer
Process engineer job in Laurinburg, NC
Purpose:
To oversee the process improvements in the hot end area to assist the shift teams in achieving plant objectives for safety, 5S, environmental, quality, cost, and throughput utilizing a continuous improvement mindset. Responsible for the Batch Plant and assisting other Hot End Process Engineers with their projects and improvements as directed.
Essential Functions:
Safety -
Complete required audits at the prescribed frequency. These may include Key Safe Behavior audits, Safety Walk and Talk, or similar.
Adhere to and enforce the Laurinburg plant Working and Safety Rules
Complete required compliance training
Be an active participant in accident and injury prevention through the use of audits, dialogue with operators, and system design.
Identify engineering solutions to potential safety issues, utilizing the safety and sustainability improvement plan to track initiatives.
Embrace and abide by the 10 Key Safety Leadership Behaviors.
Environmental -
Track area incidents and develop corrective actions as needed.
Identify, monitor, and control waste and implement recycling initiatives
Participate in identifying, reviewing, and minimizing environmental aspects and impacts.
Complete environmental training as required
Quality -
Monitor and improve process capability to ensure product conforms to customer requirements.
Perform root cause analysis and implement countermeasures for external customer issues as required.
Implementing 5S initiatives and driving continuous improvement within the plant
Process -
Identify opportunities to implement solutions to reduce waste using lean management tools to reduce costs, improve the working environment and promote safe working areas.
Monitor trends of variables in your area to ensure optimum operations using process capability and
Interface with the maintenance team to ensure the proper preventative work is being done to maintain area equipment as well as identify improvements to help minimize downtime.
Create and maintain PFMEA and reaction plans for critical variables in your area to help guide improvement, minimize the risk of unplanned process interruption, and assist the shift teams in following proper reaction protocols.
Assist in creating appropriate training tools for supervisors and shift crews.
Establish and maintain relationships with the appropriate R+D and technology resources to aid in troubleshooting process issues as needed.
Ensure processes are in line with knowledge base best practices and MST published by manufacturing excellence as much as possible.
Establish and track appropriate KPIs to establish the performance of the area and use continuous improvement methodologies to work towards improving results.
Ensure targets and daily operational plans are well communicated to shift personnel and all stakeholders to ensure consistent operational performance.
Track equipment performance, using data to determine priorities for improvements.
Ensure all material ordering is done per appropriate procedures. Procure materials and services as necessary to complete improvement initiatives.
Elevate improvement ideas for consideration of capital spending where appropriate.
Review procedures at the appropriate frequency to ensure they are still necessary and consistent with current practices.
Periodically present project updates to plant personnel or in department update meetings.
Perform inventories as needed and/or create systems to ensure appropriate inventories of process materials/supplies are available when needed.
Responsible for ensuring that the required raw materials are shipped, transported and unloaded in a safe and timely manner.
Verify that the raw materials meet all designated specifications (COA).
Oversee all unloading, storing, mixing and delivering of the raw materials.
Oversee the completion of all PM's and other maintenance issues in the batch house.
Utilize plant manning resources (cover, utility, temps) as appropriate to accomplish tasks in line with expectations.
Support the operation process, understanding the process is a 24/7 operation, becoming a member on rotation of our on-call team.
The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.
Adherence to NSG/Pilkington Standards of Business Conduct and its Values and Principles.
Other duties as assigned by manager.
Scope/Dimensions:
Interactions with all levels of managers within the plant
Interactions with operators within the plant
Interactions within the NSG group - Group Engineering, Manufacturing Excellence and other facilities
Top 3 Competencies Needed for Success in the Role:
Innovation and Change: Open to change and actively interested in new developments, technology and emerging market trends. Inspires and generates innovative ideas and solutions to enhance business results. Effectively manages the change process to ensure that the organization remains effective throughout.
Strategic Thinking: Develops strategic plans for their part of the business by setting short and long-term goals and objectives. Demonstrates a thorough understanding of the key financial data that drives profitable growth in their own area.
Empowers & Develops: Proactive in managing own self-development and learning activities. Reflects on and learns from experience. Reviews progress by providing support and guidance without undermining an individual's full ownership of issues.
Qualifications Required:
Bachelor of Science Degree in Engineering (or equivalent technical experience) is required.
Excellent interpersonal and communication skills
Ability to facilitate groups in an employee involvement environment.
Intermediate proficiency in MS office, specifically MS Excel, Word, PowerPoint.
Excellent writing skills for reports, presentations, policies, procedures, and specifications.
Qualifications Desired:
Advanced Problem-Solving Skills (Six Sigma)
Strong in analytical, innovative and strategic competencies
Practical experience in Batch plant and Furnace operations or Float Glass Forming.
Experience of identifying root causes and resolving actions to prevent reoccurrence
_____________________________________________________________________________
We offer an excellent compensation and benefits package, which includes 401k, medical, dental, vision, life insurance, company paid holidays, paid vacations, and education assistance
.
The Salary Range posted represents Pilkington North America's good faith and reasonable estimate of the possible compensation at the time of the posting. Individual pay will vary based on demonstrated job related skills, knowledge, experience, education, etc.
NSG Group/Pilkington is an equal opportunity employer; M/F/D/V encouraged to apply. Qualified candidates will receive consideration without regard to age, race, color, religion, gender, sexual orientation, disability, or national origin. Applicants have the option to confidentially self-identify or not self-identify when applying.
2026 Summer Corporate Intern - Manufacturing
Process engineer job in Sanford, NC
Your Work Shapes the World at Caterpillar Inc. When you join Caterpillar, you're joining a global team who cares not just about the work we do - but also about each other. We are the makers, problem solvers, and future world builders who are creating stronger, more sustainable communities. We don't just talk about progress and innovation here - we make it happen, with our customers, where we work and live. Together, we are building a better world, so we can all enjoy living in it.
Your Work Shapes the World at Caterpillar Inc.
When you join Caterpillar, you're joining a global team who cares not just about the work we do - but also about each other. We are the makers, problem solvers, and future world builders who are creating stronger, more sustainable communities. We don't just talk about progress and innovation here - we make it happen, with our customers, where we work and live. Together, we are building a better world, so we can all enjoy living in it.
About the Role
Caterpillar's Manufacturing, Supply Chain, and Order-to-Delivery (MSOD) Intern program seeks students currently enrolled in a four-year university to work alongside manufacturing professionals to learn and apply themselves to project work within their teams.
Interns will have assignments that provide them with experience and significant learning opportunities. In addition to this work, Interns can network with management throughout the company to learn about Caterpillar areas outside their assigned team. Students can deepen their business skills in their assignments through team and business partner interactions, develop their skills, conduct presentations, and measure their success through the performance and evaluation process.
What You Will Do
You'll join a team with diverse project responsibilities and have valuable networking opportunities with all levels of Caterpillar employees. The internship is a 40-hour-per-week assignment lasting 12 weeks.
You'll join a team with diverse project responsibilities and have experiences including (but not limited to):
* Manufacturing Engineering : Responsible and accountable for enhancements and modifications to equipment and processes in our facilities, monitoring equipment and process reliability, identifying and addressing problem areas and providing engineering support on equipment, processes, or facilities
* Quality: Analyzing non-conformance data and maintaining quality system documentation. Participating in and offering technical support to internal and external audits; following up response of corrective action from audit. Interacting with manufacturing team members to determine the root cause of quality issues and ensure that corrective and preventive action is implemented.
* Automation: Collecting and researching data on customer experience with robotic platforms. Documenting architecture specifications, software design description, verification plans, test cases, operating procedures, and safety procedures. Utilizing appropriate tools to debug, test and maintain software and hardware systems of robotic tools; assisting in the verification and validation process. Participating in design and development of application software and algorithms for robotic platforms.
What You Have - Skills and Experiences
In this role, you will have the opportunity to contribute your unique skills and experiences. Below are some of the most critical skills.
* Analytical skills, initiating ideas, troubleshooting, root cause analysis, problem-solving, and critical thinking capabilities
* Organize and manage multiple projects simultaneously, ability to quickly gain and effectively apply new skills & knowledge
* Success in collaborating with others of diverse cultures, interpersonal styles, and abilities
* Strong written and verbal communication skills
* Participate in and build on our inclusive, constructive, and productive work environment
* Ensure all team members' contributions are recognized and valued
Internship Program Qualifications:
* Must be enrolled full-time in a 4-year university/college in one of the following degree programs: Engineering, Engineering Management/Technology, Industrial Distribution/Technology, Automation Engineering Technology, Mechatronics, Robotics, Mechanical Engineering, Electrical Engineering, or other relevant degrees at the time of application and throughout the program.
* Must have 30 completed semester hours before the start of the internship.
* If a transfer student must have 12 semester hours completed at a 4-year university.
* Minimum 2.8/4.0 Cumulative Grade Point Average (no rounding) at current institution.
* Must be able to relocate to indicated work location for the duration of the internship and complete daily work commute using reliable transportation.
Top candidates can also have:
* Project or Team Leadership experience
* Previous internship, co-op, or research/relevant experience
* Excellent interpersonal and communication skills
Additional Information:
* Please attach your resume and an unofficial copy of your transcript to your application.
* Applicants will be considered for positions throughout the United States.
* Sponsorship is NOT available for this position.
* Relocation is available to those that qualify
* This position requires working onsite five days a week.
Besides exciting work, Corporate Interns will experience:
* Comprehensive internship orientation
* Tours of state-of-the-art manufacturing and research facilities
* Product Demonstration
* Mentorship Programs
* Various social events
* Networking with leadership
* Business skill building
* Career discussion with leaders and experts
Final details:
Please frequently check the email associated with your application, including the junk/spam folder, as this is the primary correspondence method. If you wish to know the status of your application - please use the candidate log-in on our career website as it will reflect any updates to your status.
Qualified applicants of any age are encouraged to apply.
For more information, visit caterpillar.com. To connect with us on social media, visit caterpillar.com/social-media.
Visa Sponsorship is not available for this position. This employer is not currently hiring foreign national applicants that require or will require sponsorship tied to a specific employer, such as, H, L, TN, F, J, E, O. As a global company, Caterpillar offers many job opportunities outside of the U.S which can be found through our employment website at ****************************
Summary Pay Range:
$25.00 - $43.00
Intern Hour Rate:
An intern's hourly rate is based on the major/degree being pursued and the number of completed academic hours achieved before the start of the internship.
Intern Benefits:
The total rewards package, beyond base salary, may include if eligible:
* Accrued Paid Time Off (PTO)
* Paid Holidays
* Paid Volunteer Day
* Housing Stipend
* Relocation Assistance
* Medical coverage
* Voluntary benefits
Relocation is available for this position.
Visa Sponsorship is not available for this position. This employer is not currently hiring foreign national applicants that require or will require sponsorship tied to a specific employer, such as, H, L, TN, F, J, E, O. As a global company, Caterpillar offers many job opportunities outside of the U.S which can be found through our employment website at ****************************
Posting Dates:
December 2, 2025 - March 30, 2026
Any offer of employment is conditioned upon the successful completion of a drug screen.
Caterpillar is an Equal Opportunity Employer, Including Veterans and Individuals with Disabilities. Qualified applicants of any age are encouraged to apply.
Not ready to apply? Join our Talent Community.
Auto-ApplySenior Manufacturing Systems Engineer - Holly Springs, NC
Process engineer job in Holly Springs, NC
ATTENTION MILITARY AFFILIATED JOB SEEKERS
- Our organization works with partner companies to source qualified talent for their open roles. The following position is available to
Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers
. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
Senior Manufacturing Systems Engineer: Automation - DeltaV
What you will do
Let's do this. Let's change the world. As a Senior Manufacturing Systems Engineer, you will provide automation technical leadership to a group of automation engineers who are responsible for building and maintaining various automation systems and platforms that support the GMP Drug Substance Plant Operations.
In this vital role as a member of the Facilities & Engineering (F&E) Automation team you will work hand in hand with the capital project team to deliver robust process automation systems to operate the new plant.
Site design, construction, start-up, and operational readiness
Collaborate with key stakeholders and end-users to understand and synthesize key process requirements, and to develop solutions using Amgen standard automation platform for process automation systems
Support design phases to ensure design aligns with Amgen specifications, incorporates the latest technology, and meets safety requirements
Support vendor FAT to ensure that control strategy and software code meet Amgen requirements
Develop and maintain engineering and maintenance documentation, and associated procedures for delivered solutions and processes
Collaborate with cross-functional teams to develop a robust commissioning and qualification plan and/or qualification strategy
Support commissioning and qualification including Automation Installation Verification/Automation Check Out (IV/ACO)
Support QA partners in performing computerized systems validation in a GxP environment
Perform Data Integrity Assessments (DIA) in accordance with the current Amgen and industry standards
Site Operations
Own and drive to completion Change Controls, CAPAs, and Deviations
Lead and support technical root cause analysis, incident investigations, and troubleshooting
Lead and support functional area projects focused on improving process equipment, utilities, and facilities as well as large capital projects to integrate new drug substance manufacturing technologies into the facility
Drive continuous improvement for process automation systems to improve operational workflows, safety, reliability, efficiency, and sustainability
Support day-to-day operations including rotational on-call support
Perform and maintain Data Integrity Assessments (DIA) in accordance with the current Amgen and industry standards
Additional Qualifications/Responsibilities
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The automation professional we seek is an engineer with these qualifications:
Basic Qualifications:
High School diploma/GED and 10 years of engineering experience OR
Associate's degree and 8 years of engineering experience OR
Bachelor's degree and 4 years of engineering experience OR
Master's degree and 2 years of engineering experience OR
Doctorate degree
Preferred Qualifications:
Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field
Direct knowledge of automation system design
Experience in programming, installation and lifecycle management of automation and field instrumentation technologies
Experience in automation of GMP biopharmaceutical equipment and systems such as buffer prep and hold, chromatography, single use mixing vessels, depth filtration, and solution prep
Experience in integrating various OEM automation software
Experience in programming, design, installation and lifecycle management of manufacturing process controls, and automation and field instrumentation technologies.
Experience with Emerson DeltaV DCS system and ability to perform advanced troubleshooting, and system integration using OPC, Foundation Fieldbus, and Profibus technologies
Ability to interpret and apply GAMPs and GMPs, and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, S88 and S95
Self-directed team player able to work cross-functionally
Strong leadership, technical writing, and communication skills
Ability for domestic and international travel
Salary Range
142,955.00 USD - 162,947.00 USD
Process Engineer
Process engineer job in Sanford, NC
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at *****************
Purpose and Scope:
The Process Engineer is responsible for providing technical support to help ensure the successful deployment of new equipment, single-use systems, and processes; support and troubleshoot existing equipment and systems for pre-clinical through commercial manufacturing processes for drug substance; and assist in the technical transfer of processes from small/lab scale to large/commercial scale and from external partners. The role is also responsible for effective collaboration with Manufacturing, Automation, Supply Chain, Warehouse, Technical Development, Quality, Regulatory, Facilities, Validation, and various vendors. This role is based in Sanford, NC.
Essential Job Responsibilities:
Provide process engineering, design, and on-going improvements for drug substance manufacturing processes
Process subject matter expert in either upstream or downstream drug substance manufacturing with ability to support multiple modalities
Matrix leadership of cross-functional teams to define and implement a robust process control strategy commensurate with program phase from pre-clinical through commercialization
Support Single-Use (SU) program development and execution and consumable design and material qualification in collaboration with internal and external partners
Evaluate new technologies that will enhance control of production processes and help coordinate deployment across the manufacturing network as appropriate and
Interact closely with vendors for SU materials and equipment procurement, as well as new technology implementation
Routine trending of process data to enhance process understanding, proactively identify gaps and issues, and implement process improvements
Author and review process descriptions, standard operating procedures, technical reports, risk assessments, campaign summary reports, health authority briefing documents, submissions, and responses, tech transfer plans/reports, PPQ protocols/reports, process control strategy, and engineering study protocols/reports
Support/lead tech transfer, equipment commissioning, training, and validation activities
Provide on-the-floor support to implement improvements for process, equipment, or operational procedures including evaluation and testing of new technologies, new operating strategies, and process and equipment troubleshooting for GMP manufacturing
Support recipe generation and updates for process equipment such as bioreactors, chromatography systems, and TFF systems
Support process deviation investigations, root cause analysis, and CAPAs
Support product lifecycle management that incorporates phase appropriate requirements and expectations from pre-clinical through commercialization and drives process optimization and cost of goods reduction
Will support and demonstrate data integrity standards to ensure data of highest quality
Hot End Process Engineer
Process engineer job in Laurinburg, NC
Purpose:
To oversee the process improvements in the hot end area to assist the shift teams in achieving plant objectives for safety, 5S, environmental, quality, cost, and throughput utilizing a continuous improvement mindset. Responsible for the Bath and Lehr and assisting other Hot End Process Engineers with their projects and improvements as directed.
Responsibility:
Responsible to complete improvement projects in areas assigned as well as assist other Hot End Process Improvers with their projects and improvements as directed. Directly reports to Bath & Lehr Team Leader.
Essential Functions:
Safety -
Complete required audits at the prescribed frequency. These may include Key Safe Behavior audits, Safety Walk and Talk, or similar.
Adhere to and enforce the Laurinburg plant Working and Safety Rules
Complete required compliance training
Be an active participant in accident and injury prevention through the use of audits, dialogue with operators, and system design.
Identify engineering solutions to potential safety issues, utilizing the safety and sustainability improvement plan to track initiatives.
Embrace and abide by the 10 Key Safety Leadership Behaviors.
Environmental -
Track area incidents and develop corrective actions as needed.
Identify, monitor, and control waste and implement recycling initiatives
Participate in identifying, reviewing, and minimizing environmental aspects and impacts.
Complete environmental training as required
Quality -
Monitor and improve process capability to ensure product conforms to customer requirements.
Perform root cause analysis and implement countermeasures for external customer issues as required.
Create and maintain metrology routines for critical measurement systems
Process -
Monitor energy usage in assigned area and identify opportunities to reduce energy consumption where identified.
Using process characterization, create Processes of Record (POR) for processes within your area and ensure that the supervisors understand them and can effectively implement them.
Identify opportunities to implement solutions to reduce waste using lean management tools to reduce costs, improve the working environment and promote safe working areas.
Monitor trends of variables in your area to ensure optimum operations using process capability and
Interface with the maintenance team to ensure the proper preventative work is being done to maintain area equipment as well as identify improvements to help minimize downtime.
Create and maintain PFMEA and reaction plans for critical variables in your area to help guide improvement, minimize the risk of unplanned process interruption, and assist the shift teams in following proper reaction protocols.
Assist in creating appropriate training tools for supervisors and shift crews.
Establish and maintain relationships with the appropriate R+D and technology resources to aid in troubleshooting process issues as needed.
Ensure processes are in line with knowledge base best practices and MST published by manufacturing excellence as much as possible.
Establish and track appropriate KPIs to establish the performance of the area and use continuous improvement methodologies to work towards improving results.
Ensure targets and daily operational plans are well communicated to shift personnel and all stakeholders to ensure consistent operational performance.
Track equipment performance, using data to determine priorities for improvements.
Ensure all material ordering is done per appropriate procedures. Procure materials and services as necessary to complete improvement initiatives.
Elevate improvement ideas for consideration of capital spending where appropriate.
Review procedures at the appropriate frequency to ensure they are still necessary and consistent with current practices.
Periodically present project updates to plant personnel or in department update meetings.
Perform inventories as needed and/or create systems to ensure appropriate inventories of process materials/supplies are available when needed.
Utilize plant manning resources (cover, utility, temps) as appropriate to accomplish tasks in line with expectations.
The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.
Adherence to NSG/Pilkington Standards of Business Conduct and its Values and Principles.
Other duties as assigned by manager.
Top 3 Competencies Needed for Success in the Role:
Innovation and Change: Open to change and actively interested in new developments, technology and emerging market trends. Inspires and generates innovative ideas and solutions to enhance business results. Effectively manages the change process to ensure that the organization remains effective throughout.
Strategic Thinking: Develops strategic plans for their part of the business by setting short and long-term goals and objectives. Demonstrates a thorough understanding of the key financial data that drives profitable growth in their own area.
Empowers & Develops: Proactive in managing own self-development and learning activities. Reflects on and learns from experience. Reviews progress by providing support and guidance without undermining an individual's full ownership of issues.
Qualifications Required:
Bachelor of Science Degree in Engineering (or equivalent technical experience) is required.
Excellent interpersonal and communication skills
Ability to facilitate groups in an employee involvement environment.
Intermediate proficiency in MS office, specifically MS Excel, Word, PowerPoint.
Excellent writing skills for reports, presentations, policies, procedures, and specifications.
Qualifications Desired:
Advanced Problem-Solving Skills (Six Sigma)
Strong in analytical, innovative and strategic competencies
Practical experience in Batch plant and Furnace operations, Float Glass Forming, Annealing and/or online CVD coating is desired.
_____________________________________________________________________________
We offer an excellent compensation and benefits package, which includes 401k, medical, dental, vision, life insurance, company paid holidays, paid vacations, and education assistance
.
The Salary Range posted represents Pilkington North America's good faith and reasonable estimate of the possible compensation at the time of the posting. Individual pay will vary based on demonstrated job related skills, knowledge, experience, education, etc.
NSG Group/Pilkington is an equal opportunity employer; M/F/D/V encouraged to apply. Qualified candidates will receive consideration without regard to age, race, color, religion, gender, sexual orientation, disability, or national origin. Applicants have the option to confidentially self-identify or not self-identify when applying.
2026 Summer Corporate Intern - Manufacturing
Process engineer job in Sanford, NC
**Your Work Shapes the World at Caterpillar Inc.** When you join Caterpillar, you're joining a global team who cares not just about the work we do - but also about each other. We are the makers, problem solvers, and future world builders who are creating stronger, more sustainable communities. We don't just talk about progress and innovation here - we make it happen, with our customers, where we work and live. Together, we are building a better world, so we can all enjoy living in it.
**Your Work Shapes the World at Caterpillar Inc.**
When you join Caterpillar, you're joining a global team who cares not just about the work we do - but also about each other. We are the makers, problem solvers, and future world builders who are creating stronger, more sustainable communities. We don't just talk about progress and innovation here - we make it happen, with our customers, where we work and live. Together, we are building a better world, so we can all enjoy living in it.
**About the Role**
Caterpillar's Manufacturing, Supply Chain, and Order-to-Delivery (MSOD) Intern program seeks students currently enrolled in a four-year university to work alongside manufacturing professionals to learn and apply themselves to project work within their teams.
Interns will have assignments that provide them with experience and significant learning opportunities. In addition to this work, Interns can network with management throughout the company to learn about Caterpillar areas outside their assigned team. Students can deepen their business skills in their assignments through team and business partner interactions, develop their skills, conduct presentations, and measure their success through the performance and evaluation process.
**What You Will Do**
You'll join a team with diverse project responsibilities and have valuable networking opportunities with all levels of Caterpillar employees. The internship is a 40-hour-per-week assignment lasting 12 weeks.
You'll join a team with diverse project responsibilities and have experiences including (but not limited to):
+ **Manufacturing** **Engineering ** : Responsible and accountable for enhancements and modifications to equipment and processes in our facilities, monitoring equipment and process reliability, identifying and addressing problem areas and providing engineering support on equipment, processes, or facilities
+ **Quality** : Analyzing non-conformance data and maintaining quality system documentation. Participating in and offering technical support to internal and external audits; following up response of corrective action from audit. Interacting with manufacturing team members to determinethe root cause of quality issues and ensure that corrective and preventive action is implemented.
+ **Automation:** Collecting and researching data on customer experience with robotic platforms. Documenting architecture specifications, software design description, verification plans, test cases, operating procedures, and safety procedures. Utilizing appropriate tools to debug, test and maintain software and hardware systems of robotic tools; assisting in the verification and validation process. Participating in design and development of application software and algorithms for robotic platforms.
**What You Have - Skills and Experiences**
In this role, you will have the opportunity to contribute your unique skills and experiences. Below are some of the most critical skills.
+ Analytical skills, initiating ideas, troubleshooting, root cause analysis, problem-solving, and critical thinking capabilities
+ Organize and manage multiple projects simultaneously, ability to quickly gain and effectively apply new skills & knowledge
+ Success in collaborating with others of diverse cultures, interpersonal styles, and abilities
+ Strong written and verbal communication skills
+ Participate in and build on our inclusive, constructive, and productive work environment
+ Ensure all team members' contributions are recognized and valued
**Internship Program Qualifications:**
+ Must be enrolled full-time in a 4-year university/college in one of the following degree programs: Engineering, Engineering Management/Technology, Industrial Distribution/Technology, Automation Engineering Technology, Mechatronics, Robotics, Mechanical Engineering, Electrical Engineering, or other relevant degreesat the time of application and throughout the program.
+ Must have 30 completed semester hours before the start of the internship.
+ If a transfer student must have 12 semester hours completed at a 4-year university.
+ Minimum 2.8/4.0 Cumulative Grade Point Average (no rounding) at current institution.
+ Must be able to relocate to indicated work location for the duration of the internship and complete daily work commute using reliable transportation.
**Top candidates can also have:**
+ Project or Team Leadership experience
+ Previous internship, co-op, or research/relevant experience
+ Excellent interpersonal and communication skills
**Additional Information:**
+ Please attach your resume and an unofficial copy of your transcript to your application.
+ Applicants will be considered for positions throughout the United States.
+ Sponsorship is **NOT** available for this position.
+ Relocation is available to those that qualify
+ This position requires working onsite five days a week.
Besides exciting work, Corporate Interns will experience:
+ Comprehensive internship orientation
+ Tours of state-of-the-art manufacturing and research facilities
+ Product Demonstration
+ Mentorship Programs
+ Various social events
+ Networking with leadership
+ Business skill building
+ Career discussion with leaders and experts
**Final details:**
Please frequently check the email associated with your application, including the junk/spam folder, as this is the primary correspondence method. If you wish to know the status of your application - please use the candidate log-in on our career website as it will reflect any updates to your status.
Qualified applicants of any age are encouraged to apply.
For more information, visit caterpillar.com. To connect with us on social media, visit caterpillar.com/social-media.
Visa Sponsorship is not available for this position. This employer is not currently hiring foreign national applicants that require or will require sponsorship tied to a specific employer, such as, H, L, TN, F, J, E, O. As a global company, Caterpillar offers many job opportunities outside of the U.S which can be found through our employment website at *************************** .
**Summary Pay Range:**
$25.00 - $43.00
**Intern Hour Rate:**
An intern's hourly rate is based on the major/degree being pursued and the number of completed academic hours achieved before the start of the internship.
**Intern Benefits:**
The total rewards package, beyond base salary, may include if eligible:
+ Accrued Paid Time Off (PTO)
+ Paid Holidays
+ Paid Volunteer Day
+ Housing Stipend
+ Relocation Assistance
+ Medical coverage
+ Voluntary benefits
Relocation is available for this position.
Visa Sponsorship is not available for this position. This employer is not currently hiring foreign national applicants that require or will require sponsorship tied to a specific employer, such as, H, L, TN, F, J, E, O. As a global company, Caterpillar offers many job opportunities outside of the U.S which can be found through our employment website at ***************************.
**Posting Dates:**
December 2, 2025 - March 30, 2026
Any offer of employment is conditioned upon the successful completion of a drug screen.
Caterpillar is an Equal Opportunity Employer, Including Veterans and Individuals with Disabilities. Qualified applicants of any age are encouraged to apply.
Not ready to apply? Join our Talent Community (*********************************************** .
Senior Manufacturing System Engineer Automation -Holly Springs,NC
Process engineer job in Holly Springs, NC
ATTENTION MILITARY AFFILIATED JOB SEEKERS
- Our organization works with partner companies to source qualified talent for their open roles. The following position is available to
Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers
. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
Let's do this. Let's change the world. As a Senior Manufacturing Systems Engineer, you will provide automation technical leadership to a group of automation engineers who are responsible for building and maintaining various automation systems and platforms that support the GMP Drug Substance Plant Operations.
In this vital role as a member of the Facilities & Engineering (F&E) Automation team you will work hand in hand with the capital project team to deliver robust process automation systems to operate the new plant.
Site design, construction, start-up, and operational readiness
Collaborate with key stakeholders and end-users to understand and synthesize key process requirements, and to develop solutions using Amgen standard automation platform for process automation systems
Support design phases to ensure design aligns with Amgen specifications, incorporates the latest technology, and meets safety requirements
Support vendor FAT to ensure that control strategy and software code meet Amgen requirements
Develop and maintain engineering and maintenance documentation, and associated procedures for delivered solutions and processes
Collaborate with cross-functional teams to develop a robust commissioning and qualification plan and/or qualification strategy
Support commissioning and qualification including Automation Installation Verification/Automation Check Out (IV/ACO)
Support QA partners in performing computerized systems validation in a GxP environment
Perform Data Integrity Assessments (DIA) in accordance with the current Amgen and industry standards
Site Operations
Own and drive to completion Change Controls, CAPAs, and Deviations
Lead and support technical root cause analysis, incident investigations, and troubleshooting
Lead and support functional area projects focused on improving process equipment, utilities, and facilities as well as large capital projects to integrate new drug substance manufacturing technologies into the facility
Drive continuous improvement for process automation systems to improve operational workflows, safety, reliability, efficiency, and sustainability
Support day-to-day operations including rotational on-call support
Perform and maintain Data Integrity Assessments (DIA) in accordance with the current Amgen and industry standards
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The automation professional we seek is an engineer with these qualifications:
Additional Qualifications/Responsibilities
Basic Qualifications:
High School diploma/GED and 10 years of engineering experience OR
Associate's degree and 8 years of engineering experience OR
Bachelor's degree and 4 years of engineering experience OR
Master's degree and 2 years of engineering experience OR
Doctorate degree
Preferred Qualifications:
Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field
Direct knowledge of automation system design
Experience in programming, installation and lifecycle management of automation and field instrumentation technologies
Experience in automation of GMP biopharmaceutical equipment and systems such as buffer prep and hold, chromatography, single use mixing vessels, depth filtration, and solution prep
Experience in integrating various OEM automation software
Experience in programming, design, installation and lifecycle management of manufacturing process controls, and automation and field instrumentation technologies.
Experience with Emerson DeltaV DCS system and ability to perform advanced troubleshooting, and system integration using OPC, Foundation Fieldbus, and Profibus technologies
Ability to interpret and apply GAMPs and GMPs, and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, S88 and S95
Self-directed team player able to work cross-functionally
Strong leadership, technical writing, and communication skills
Ability for domestic and international travel
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now and make a lasting impact with the Amgen team!
careers.amgen.com
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
142,955.00 USD - 162,947.00 USD
Associate Process Engineer - Biopharma (JP13416)
Process engineer job in Holly Springs, NC
Business Unit: Engineering & Automation Employment Type: Contract Duration: 12 months with possible extensions or conversion to FTE Rate: $30-33/hr W2 with benefits
Posting Date: 11/26/2024
Note: 100% onsite - regular working hours - potential on call rotation occasionally.
3Key is hiring! We are looking for Associate Engineer for a consulting engagement with our direct client, a leading global biotechnology company.
Ideal Candidate: B.S. in chemical or mechanical engineering. Some pharma experience in drug substance manufacturing is a plus. Looking for a go getter with some general working experience. (Does not have to be related to this position.)
Key Responsibilities:
Develop, coordinate, analyze, and present results for operational issues and engineering projects
Provide technical support to commercial and clinical manufacturing as needed, specific to process control and process equipment.
Working closely with multiple subject areas, including manufacturing, process engineering, process development, utility operations, maintenance, quality assurance, and validation to implement operational improvements
Communicating with supervisor and support staff, highlighting issues and proposing solutions.
Work in a small group of engineers and/or technicians on an ongoing or project basis.
Complete tasks under the general direction of lead engineers to complete design and engineering within schedule and budget constraints.
Provide technical support and issue resolution with 24x7 on-call support of process systems on a rotational based frequency.
Provide system ownership for assigned equipment, and supporting operations at the site.
Provide engineering support for design, construction, startup, commissioning and qualification.
Lead or work with teams in design, development and selection of new systems, instruments, calibration capabilities and consumable components.
Evaluate capabilities of current and potential suppliers, and assess new technologies that could provide cost savings, throughput, or other unique capabilities to Amgen manufacturing.
Identify, support, and/or lead implementation of engineering-based improvements or upgrades in small to medium scope and complexity.
Lead the development of calibration/maintenance programs, ensure the availability of spare parts, and coordinate maintenance execution as necessary to ensure systems are in proper working order.
Ensure systems are installed and operating safely and comply with pertinent environmental health/safety practice, rules and regulations.
Ensure necessary commissioning and qualification of systems is completed in alignment with site GMP requirements and interact with regulatory inspectors as necessary.
Apply basic engineering principles and practices in support of daily operation, maintenance, and troubleshooting of plant and process systems.
Monitor systems to identify performance risks and implement risk reduction strategies.
Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action. (Support may be required outside of normal working hours including nights, weekends and holidays)
Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
Advance the use of condition based and predictive maintenance practices by incorporating advanced data analytics where applicable.
Own investigations of abnormal conditions through Deviation and business processes.
Basic Qualifications:
Bachelor's degree Or Associate's degree and 4 years of Process Engineer experience Or
High school diploma / GED and 6 years of Process Engineer experience.
Ability to provide On-Call support coverage nights and weekends, on a rotating basis.
Preferred Qualifications:
Bachelor's degree in engineering or related technical field
Position requires strong written and verbal skills and the ability to work with minimum direction.
Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team-based environment.
Ability to apply analytical skills to evaluate and interpret sophisticated problems using multiple sources of information.
Ability to function within cross-functional teams and embrace a team-based environment.
Experience with Mammalian Cell Culture, Protein Purification, Clean Utilities, CIP, SIP, Production Services, and/or non-GMP Utilities preferred
Familiarity with designing and operating equipment used in biopharmaceutical manufacturing preferred
Top Must Have Skill Sets:
Strong working ethic
Strong communication
B.S. in chemical or mechanical engineering
Pharma experience
Employee Value Proposition:
Unique industry experience
Career growth
Networking
Interview Process:
Manager screening followed by panel interviews (potential for these to be in person).
We invite qualified candidates to send your resume to *****************************. If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website ******************************* You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Regards, 3KC Talent Acquisition Team
Easy ApplySenior Process Engineer
Process engineer job in Holly Springs, NC
Career CategoryEngineeringJob DescriptionJoin Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
Senior Process Engineer
What you will do
Let's do this. Let's change the world. In this vital role you will be joining the Facilities & Engineering (F&E) group to partner closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production as well as developing domain expertise to support operations upon start up.
Provide system ownership for Biopharmaceutical process equipment. Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.
Develop equipment maintenance programs, ensure the availability of spare parts, and coordinating maintenance activities to ensure systems are in proper working order.
Ensure systems are installed and operating safety and stay in sync with pertinent environmental health/safety practice, rules and regulations.
Ensure commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors.
System guidance to identify performance risks and implement risk reduction strategies.
Providing problem solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.
Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek enjoys challenges and is motivated to help serve patients with these qualifications.
Basic Qualifications:
High school diploma / GED and 10 years of Engineering experience OR
Associate's degree and 8 years of Engineering experience OR
Bachelor's degree and 4 years of Engineering experience OR
Master's degree and 2 years of Engineering experience OR
Doctorate degree
Preferred Qualifications:
Bachelor's degree in Chemical or Mechanical Engineering
6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment with a focus on Upstream unit operations
Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors, centrifugation, chromatography, tangential flow filtration as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Data Analytics, Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and the oversight of capital projects
Understanding of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation
Understanding of safety requirements working in a GMP Biopharmaceutical Production facility.
Independent, ambitious, organized, able to multi-task in project environments, and skilled in communication, facilitation, and teamwork
Collaborative teammate prepared to work in and embrace a team based environment that relies on communication for effective decision-making
Strong leadership, technical writing, and communication/presentation skills
Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage
Ability for domestic/international travel (~10%)
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now and make a lasting impact with the Amgen team.careers.amgen.com
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
119,195.00 USD - 147,867.00 USD
Auto-ApplySenior Process Engineer
Process engineer job in Holly Springs, NC
**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
**Senior Process Engineer**
**What you will do**
Let's do this. Let's change the world. In this vital role you will be joining the Facilities & Engineering (F&E) group to partner closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production as well as developing domain expertise to support operations upon start up.
+ Provide system ownership for Biopharmaceutical process equipment. Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.
+ Develop equipment maintenance programs, ensure the availability of spare parts, and coordinating maintenance activities to ensure systems are in proper working order.
+ Ensure systems are installed and operating safety and stay in sync with pertinent environmental health/safety practice, rules and regulations.
+ Ensure commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors.
+ System guidance to identify performance risks and implement risk reduction strategies.
+ Providing problem solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.
+ Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek enjoys challenges and is motivated to help serve patients with these qualifications.
**Basic Qualifications:**
+ High school diploma / GED and 10 years of Engineering experience OR
+ Associate's degree and 8 years of Engineering experience OR
+ Bachelor's degree and 4 years of Engineering experience OR
+ Master's degree and 2 years of Engineering experience OR
+ Doctorate degree
**Preferred Qualifications:**
+ Bachelor's degree in Chemical or Mechanical Engineering
+ 6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment with a focus on Upstream unit operations
+ Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors, centrifugation, chromatography, tangential flow filtration as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
+ Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Data Analytics, Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
+ Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
+ Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and the oversight of capital projects
+ Understanding of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation
+ Understanding of safety requirements working in a GMP Biopharmaceutical Production facility.
+ Independent, ambitious, organized, able to multi-task in project environments, and skilled in communication, facilitation, and teamwork
+ Collaborative teammate prepared to work in and embrace a team based environment that relies on communication for effective decision-making
+ Strong leadership, technical writing, and communication/presentation skills
+ Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage
+ Ability for domestic/international travel (~10%)
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Associate Process Engineer, (JP13534)
Process engineer job in Holly Springs, NC
Business Unit: Engineering Automation Employment Type: Contract . Rate: $28 - $32/hour W2
Posting Date: 1/2/2025.
Notes: Only qualified candidates need apply. 100% ONSITE - regular working hours - potential on call rotation occasionally.
3 Key Consulting is hiring! We are recruiting an Associate Process Engineer for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:
Our ideal candidate will have a B.S. degree in chemical or mechanical engineering. Some pharma experience in drug substance manufacturing is a plus. Looking for a go getter with some general working experience. (Does not have to be related to this position.)
Top Must Have Skill Sets:
• Strong working ethics
• Strong communication
• B.S. in chemical or mechanical engineering
• Pharma experience
Day to Day Responsibilities:
• Develop, coordinate, analyze, and present results for operational issues and engineering projects
• Provide technical support to commercial and clinical manufacturing as needed, specific to process control and process equipment.
• Working closely with multiple subject areas, including manufacturing, process engineering, process development, utility operations, maintenance, quality assurance, and validation to implement operational improvements
• Communicating with supervisor and support staff, highlighting issues and proposing solutions.
• Work in a small group of engineers and/or technicians on an ongoing or project basis.
• Complete tasks under the general direction of lead engineers to complete design and engineering within schedule and budget constraints.
• Provide technical support and issue resolution with 24x7 on-call support of process systems on a rotational based frequency.
• Provide system ownership for assigned equipment, and support operations at the site.
• Provide engineering support for design, construction, startup, commissioning and qualification.
• Lead or work with teams in design, development and selection of new systems, instruments, calibration capabilities and consumable components.
• Evaluate capabilities of current and potential suppliers, and assess new technologies that could provide cost savings, throughput, or other unique capabilities to client manufacturing.
• Identify, support, and/or lead implementation of engineering-based improvements or upgrades in small to medium scope and complexity.
• Lead the development of calibration/maintenance programs, ensure the availability of spare parts, and coordinate maintenance execution as necessary to ensure systems are in proper working order.
• Ensure systems are installed and operating safely and comply with pertinent environmental health/safety practice, rules and regulations.
• Ensure necessary commissioning and qualification of systems is completed in alignment with site GMP requirements and interact with regulatory inspectors as necessary.
• Apply basic engineering principles and practices in support of daily operation, maintenance, and troubleshooting of plant and process systems.
• Monitor systems to identify performance risks and implement risk reduction strategies.
• Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action. (Support may be required outside of normal working hours including nights, weekends and holidays)
• Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
• Advance the use of condition based and predictive maintenance practices by incorporating advanced data analytics where applicable.
• Own investigations of abnormal conditions through Deviation and business processes.
Basic Qualifications:
• Bachelor's degree, Or
• Associate's degree and 4 years of Process Engineer experience, Or
• High school diploma / GED and 6 years of Process Engineer experience
• Ability to provide On-Call support coverage nights and weekends, on a rotating basis.
Preferred Qualifications:
• Bachelor's degree in engineering or related technical field
• Position requires strong written and verbal skills and the ability to work with minimum direction.
• Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team-based environment.
• Ability to apply analytical skills to evaluate and interpret sophisticated problems using multiple sources of information.
• Ability to function within cross-functional teams and embrace a team-based environment.
• Experience with Mammalian Cell Culture, Protein Purification, Clean Utilities, CIP, SIP, Production Services, and/or non-GMP Utilities preferred
• Familiarity with designing and operating equipment used in biopharmaceutical manufacturing preferred
Interview Process:
Manager screening followed by panel interviews (potential for these to be in person).
We invite qualified candidates to send your resume to **************************. If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website ******************************* You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Regards, 3KC Talent Acquisition Team
Easy Apply