Quality Assurance Manager
Quality engineer job in Dayton, NJ
JOB PURPOSE :
Responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that materials and products are inspected and released in compliance with cGMP guidelines, USP and FDA, EU requirements. Responsible for first shift QA In-Process and In-coming Groups, getting all the QA batch record documents approved for timely release of finished products and timely release of incoming materials. Work closely with Operations (Filling and Packaging) and other groups as necessary to troubleshoot issues in the warehouse, filling and packaging floors and ensure timely reporting of events. Work closely with compliance group at times of external audits (FDA or vendors). Ensure that non-compliant situations are thoroughly investigated.
KEY ACCOUNTABILITIES:
Regular and predictable onsite attendance and punctuality.
Directs the incoming and in-process QA groups. Makes final accept/reject disposition on incoming materials, including but not limited to raw materials, components, production commodities. Assures batch is manufactured Ensures that records are reviewed and released in a timely manner.
Coordinates communication for status of incoming materials and resolves issues related to accept/reject disposition of materials.
Coordinates communication of production status to next shift; attends daily update meetings as required.
Manages personnel for in-process filling and inspection/packaging monitoring.
Provides QA review and approval of manufacturing investigations, as necessary, assuring timely review, follow-up, tracking and trending of MIRs. Provide guidance to the investigator, as required
Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR's, Commissioning Documents, FAT's), engineering documents.
Expedites and prioritizes product releases by coordinating the Review of QA documentation to meet customer service requirements.
Conducts routine investigation and departmental meetings to facilitate the performance of release function, with respect to incoming materials.
Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff.
Places lots on HOLD if Quality issues are detected and notifies senior management.
Assists the QA management in developing on department budget.
Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions.
Manages attendance records for all direct reports.
QUALIFICATIONS:
College Degree within a science related discipline such as a B.S. in Pharmacy, Science, Engineering or other related fields is required with 10+ years' experience, or Masters' Degree in Microbiology, or biological science with 3-6 years' experience
Ph.D. in relevant field with 0-3 years' experience
Preferred: Additional college courses in Microbiology, cGMPs, Statistics or Quality Management are beneficial
EXPERIENCE:
Minimum: Experience in the Pharmaceutical Industry in the field of Quality Assurance or Production is a must
SKILLS:
Must have history of strong documentation skills and attention to detail
Familiarity with cGMPs and CFR for US and EU
Excellent organizational skills and ability to multi-task and perform work in a timely manner
Demonstrates ability to lead a department, projects and meetings effectively
Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management
General computer skills and ability to prepare presentations and address large groups
Demonstrated attention to details and accuracy
The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must
Mentoring abilities as well as effective communication, (written and oral) are required.
What We Offer*:
Annual performance bonus, commission, and share potential
Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
3 personal days (prorated based on hire date)
11 company paid holidays
Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
Employee discount program
Wellbeing rewards program
Safety and Quality is a top organizational priority
Career advancement and growth opportunities
Tuition reimbursement
Paid maternity and parental leave
*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.
Equal Opportunity Employer:
Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
Quality Project Manager
Quality engineer job in Horsham, PA
This position will lead and participate in projects for the integration of new products into systems that impact the US Pharm Local Operating Company (LOC) and Deliver organizations. Open to candidates located in Horsham PA or Titusville NJ.
Responsibilities:
Key responsibilities include, but are not limited to:
Projects (100%)
Provide project leadership and support related to quality systems for US Pharm CQ and US Deliver initiatives.
Complete GMP documentation to ensure compliance.
Track completion of project deliverables.
Coordinate and collaborate with project team members.
Propose process improvements.
Provide routine project updates.
Perform additional tasks as needed to support project deliverables.
Others:
Execute compliance activities on behalf of team leadership, including but not limited to the creation and revision of regional and local procedures and/or work instructions.
Escalate appropriate issues to management.
Make quality decisions based on assessments of compliance risks, balanced with overall business needs.
Drive strategic initiatives for both CQ and distribution centers.
Ensure strategies are implemented and closed out in a compliant and timely manner.
Experience:
Minimum of 3 years' experience in the Medical Device, Pharmaceutical, or Consumer Products industry.
Experience working in a highly regulated industry.
Proven experience leading projects and influencing team members to achieve results without direct supervision.
Strong written and verbal communication skills, with the ability to take initiative independently as well as collaborate as part of a team.
Demonstrated problem-solving, decision-making, data analysis, inductive reasoning, critical thinking, and root cause analysis skills.
Excellent communication and presentation skills.
Strong change management, collaboration, and influencing skills to effectively partner across functions.
Ability to work under tight timelines and maintain customer focus.
Must be able to manage and provide leadership across multiple sites.
Advanced proficiency in PowerPoint and Microsoft Excel, including VLOOKUPs and pivot tables.
Demonstrated flexibility to handle complexity and multiple initiatives.
Proven ability to successfully partner and collaborate with business partners outside of Quality.
Experience interpreting compliance requirements and regulations.
Preferred Skills and Experience:
Project Management certifications.
Understanding of FDA 21 CFR Part 210, 211, ISO 9001 and/or ISO 13485.
Understanding of Installation Qualification, Operational Qualification, Process Qualification (IQ, OQ, PQ), and associated report writing.
Familiarity with Comet.
Skills:
Project Management
Biomedical Industry
Pharmaceutical Regulatory Compliance
Education:
Bachelor's/University degree.
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit ************************
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Recruiter Details:
Name: Azhar
Email: ****************************
Internal Id: 25-53768
Manager, Plant Quality
Quality engineer job in Holmdel, NJ
Safety is a core value at Voyant Beauty. We prioritize the well-being of our team members, ensuring a safe and secure environment where everyone can thrive and excel. If you're seeking to be part of a team where your talents are valued, your safety is paramount, and your efforts contribute to meaningful change, then Voyant Beauty is the place for you. Come join us and be a part of our journey.
A Brief OverviewThe Plant Quality Manager provides strategic and operational leadership for all quality functions at a high-volume OTC manufacturing facility. This role ensures GMP compliance, drives a quality culture, and leads quality system improvements to enhance overall site performance. As a critical leader, the Plant Quality Manager will strengthen the Quality organization, foster quality culture transformation, and optimize operational excellence across the facility. The ideal candidate is a hands-on, technically proficient leader with cGMP knowledge (21 CFR 210/211) and the ability to align cross-functional teams to elevate the site's quality systems and compliance.What you will do
Lead QA, QC Labs, Document Control, Validation, and Complaint Management operations.
Oversee implementation and improvement of site QMS in line with FDA and corporate standards.
Serve as quality site lead for FDA and customer inspections. Ensures inspection readiness at all times.
Address compliance issues and manage CAPAs effectively.
Promote accountability, data integrity, and a right-first-time mindset.
Collaborate with Ops, Eng, R&D, etc., on investigations, change management, validations, and continuous improvement.
Supervise review of batch records, product release, deviations, and investigations.
Work with customers, and other stakeholders to meet compliance expectations.
Analyze metrics to drive performance and quality improvement.
Coach and develop a High Performing Team. Ensure effective resourcing of quality teams.
Represent site quality leadership in executive meetings.
Contribute to corporate quality strategy alignment.
Participate in strategic planning and facility expansion discussions.
Some duties may vary slightly by location.
Education Qualifications
Bachelor's Degree in Chemistry, Pharmacy, Microbiology, Chemical Engineering, or similar. (Preferred)
advanced degree (Preferred)
Experience Qualifications
10+ years in FDA-regulated OTC, pharmaceutical, or personal care environments. (Preferred)
10+ years managing FDA inspections and remediation efforts. (Preferred)
10+ years background in aerosol manufacturing and topical formulations is a plus. (Preferred)
Skills and Abilities
Expertise in cGMPs, 21 CFR 210/211, ICH, USP (High proficiency)
Leading FDA/customer audits and inspection readiness (High proficiency)
Remediation planning and effectiveness verification (High proficiency)
Working with Ops, Eng, and R&D on QMS topics (High proficiency)
Team coaching, mentoring, and resourcing (High proficiency)
Effective internal/external stakeholder communication (High proficiency)
ERP (e.g., SAP), LIMS (e.g., MasterControl), TrackWise (High proficiency)
Driving transformation in quality mindset and execution (High proficiency)
Licenses and Certifications
ASQ Certification (Preferred)
Lean Six Sigma or OpEx training (Preferred)
To Staffing and Recruiting Agencies: Our company does not accept unsolicited curriculum vitae's or applications from agencies. We are not responsible for any fees related to unsolicited curriculum vitae's or applications and explicitly reserve its right to contact candidates presented in such unsolicited curriculum vitae's or application.
Our company provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, color, national origin, sexual orientation, age, disability or veteran status. Voyant Beauty will consider requests for accommodations due to a disability impacting a qualified employee's ability to perform the essential functions of their position consistent with applicable laws. In addition to federal law requirements, Voyant Beauty complies with applicable provincial and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Supplier Quality Manager
Quality engineer job in Raritan, NJ
OVERALL RESPONSIBILITIES: Customer Quality member responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions. These activities include intake, investigation, documentation, follow-up, regulatory reporting and metrics. The Customer Quality Specialist is responsible for the oversight and direct support of technical evaluations and investigational tasks required for complaint processing/closure. The Customer Quality Specialist works collaboratively with Quality, Engineering, Manufacturing, Product Development and other functional experts.
DUTIES:
• Responsible and accountable for on-time submission and accuracy of regulatory reports
• Review and complete determination associated Medical Device Report and/or Vigilance Report
• Knowledge of and familiarity with global regulations for reporting
• Directly interface with service centers, Hospitals, Surgeons, and Internal employees for reporting of complaints and adverse events
• Interact positively with internal, external business partners and colleagues
• Adhere and comply to work instructions, standard operating procedures, and regulations
• Expedite investigations by collaborating with internal/external business partners
• Achieve productivity targets
• Fully trained within three months of hire
• Achieve accuracy targets for complaint documentations
• Participate in projects and events
• Complaint determination
• Reportability assessments
• Conduct follow-ups with complainant, reporters
• Checking your own work
• Updating SharePoint
• Tracking complaints in the process for closure
• All other duties as assigned
Qualifications
• Bachelor's Degree or equivalent experience
• Generally requires 2-4 years of related work experience
• RAC or ASQ certifications a plus
Additional Information
All your information will be kept confidential according to EEO guidelines.
Manufacturing Engineer
Quality engineer job in Princeton, NJ
Established in 1991, Collabera is one of the fastest growing end-to-end information technology services and solutions companies globally. As a half a billion dollar IT company, Collabera's client-centric business model, commitment to service excellence and Global Delivery Model enables its global 2000 and leading mid-market clients to deliver successfully in an increasingly competitive marketplace.
With over 8200 IT professionals globally, Collabera provides value-added onsite, offsite and offshore technology services and solutions to premier corporations. Over the past few years, Collabera has been awarded numerous accolades and Industry recognitions including.
• Collabera awarded Best Staffing Company to work for in 2012 by SIA. (hyperlink here)
• Collabera listed in GS 100 - recognized for excellence and maturity
• Collabera named among the Top 500 Diversity Owned Businesses
• Collabera listed in GS 100 & ranked among top 10 service providers
• Collabera was ranked:
• 32 in the Top 100 Large Businesses in the U.S
• 18 in Top 500 Diversity Owned Businesses in the U.S
• 3 in the Top 100 Diversity Owned Businesses in New Jersey
• 3 in the Top 100 Privately-held Businesses in New Jersey
• 66th on FinTech 100
• 35th among top private companies in New Jersey
***********************************************
Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence. Collabera offers a full range of benefits to its employees including paid vacations, holidays, personal days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance, Disability Insurance.
Job Description
This position is for an Electrical Engineer with 8+ years of experience in a similar role.
The chosen Candidate MUST have experience with medical quality systems and procedures so previous experience in the Medical Device industry is expected.
Candidates MUST have strong working knowledge of design for low power and low noise applications.
Experience in board layout for mixed signal/low noise applications.
Candidates without this previous experience will not be considered.
Familiarity with system grounding/shielding and EMI mitigation design techniques.
Experience in board layout for high density, high speed/performance digital interfaces (PADS preferred).
Experience in schematic entry (OrCAD preferred).
Familiarity with EMC and Safety testing.
Good laboratory measurement skills (analog and digital).
Knowledge of MS Office documentation, spreadsheet, and presentation tools.
Established industry circuit design experience
Qualifications
Candidates best suited for this position will typically have obtained a Bachelor's degree and 8+ years of experience in a related field or a suitable combination of experience and education relative to the position.
Additional Information
All your information will be kept confidential according to EEO guidelines.
Quality Technician
Quality engineer job in Warminster, PA
Job Details Warminster, PA Full Time DaylightDescription
Quality Technician
Penn United Technologies, Inc. has an immediate need for full-time Quality Technician to join our Plastic Injection Mold team at our Warminster, PA location. As a Quality Technician, you would be responsible for working with various manufacturing teams to achieve quality production and work to continually improve manufacturing processes to help ensure customer satisfaction.
About Us:
Penn United, a leading advanced contract manufacturer since 1971, provides the highest quality precision manufactured solutions for our customers' complex needs. Our broad range of manufacturing services support a variety of industries including medical, defense and aerospace, connectivity, energy, fluid handling, and precision components for consumer goods. Through our diverse range of capabilities which includes Plastic Injection Molding, Engineering, Precision Machining/Grinding, Stamping, Carbide Manufacturing, Additive Manufacturing and more, our work plays a vital role in products used around the world every day. Penn United Technologies currently employs over 650 people across all divisions of our employee-owned precision manufacturing company. Our Plastic Injection Molding team is located in Warminster, PA approximately an hour north of Philadelphia.
Responsibilities:
Work with manufacturing technicians to achieve acceptable product, meet or exceed customer quality standards, goals and deliveries
Perform inspections and audits of materials and audit manufacturing processes
Utilize inspection tools such as micrometers, indicators, digital height gage and comparators as needed
Identify and report discrepancies with standard, placing all nonconforming product on hold
Create, maintain and file inspection logs and quality documents
Audit manufacturing technician inspection logs and SPC charts, verifying with product samples
Assist with or perform First Articles, Gage R&R and Capability Studies, etc.
Assist in training quality and manufacturing team to follow inspection procedures and in the use of inspection equipment
Maintain clean equipment and work area
Qualifications
Qualifications:
Knowledge and Skills
Understanding of blueprint reading and inspection techniques
High degree of accuracy, attention to details and deadlines
Strong reading, comprehension, math and problem-solving skills
Capable of completing application training on:
- Statistics/Statistical Process Control
- Measurement/inspection equipment
- Technical Math
- Geometric Dimensioning and Tolerancing (dependent on job assignment)
Visual acuity (20/20 vision or corrective lenses)
Basic computer literacy, including Microsoft Office Suite
Able to work well independently and cooperatively with teams
Excellent organizational skills, self-motivated, able to effectively manage multiple tasks
Strong ability to professional communicate using verbal and written skills
Candidates must be able to work daylight shift, lift up to 40 lbs., and stand 8-10 hours per day
Education/Experience
Required: High school diploma or equivalent
Desired: Experience with Smart Scopes and Quest machines
What we offer you:
We offer an array of excellent benefits that reflect our commitment to the health and financial well-being of our employee-owners including:
COMPETITIVE STARTING WAGE WITH THE OPPORTUNITY FOR TWO PAY INCREASES IN THE FIRST YEAR
HEALTH BENEFITS
Medical, dental, vision, Rx insurance that starts the first day
Flexible Spending Account (FSA)
Employee Assistance Program (EAP)
Hearing Aid Coverage
RETIREMENT
ESOP: 5% Company paid contribution to our Employee Stock Ownership Plan
401K: 3% Company paid contribution
401K: 50% Company paid match up to the first 6% you contribute
MONTHLY PROFIT-SHARING PROGRAM
WORK / LIFE BALANCE - Paid Time Away from Work
15 Days Paid Time Off (PTO) your first year
9 Paid Holidays
OTHER INSURANCE COVERAGE
Group Term Life
Short Term Disability (after 90 days)
Long Term Disability (after 6 months)
Voluntary Benefit package
ADDITIONAL BENEFITS
Tuition Reimbursement
Safety Equipment (PPE) Reimbursement
Years of Service Awards
Equal Opportunity Employer /Veterans/Disability
Engineer, Process
Quality engineer job in Somerset, NJ
Job Title Engineer, Process Division L'Oréal Dermatological Beauty Reports To: Senior Manager, Process Expert Who We Are: For more than a century, L'Oréal has devoted its energy, innovation, and scientific excellence solely to one business: Beauty. Our goal is to offer each and every person around the world the best of beauty in terms of quality, efficacy, safety, sincerity and responsibility to satisfy all beauty needs and desires in their infinite diversity.
At L'Oréal Dermatological Beauty, our mission is to help everyone in their quest for healthy and beautiful skin. Our division is the world leader in dermo-cosmetics by adding health to beauty. Our brands portfolio includes CeraVe, La Roche-Possay, Vichy, SkinCeuticals offering a range of skincare and haircare products to respond to all expectations linked to beauty and health of the skin.
What You Will Learn:
Works independently to complete functional tasks as directed. Develop bulk manufacturing procedures to support new product launches and projects at plant and contract manufacturer. Act as a technical resource for the Unit of Production Bulk Processing Department. Problem solves difficult technical issues with robust, efficient and cGMP compliant solutions.
* Participates and leads formula and process risk assessment in plant. Influence sound and technically robust solution in formula/process development with Pilot and UP.
* Based on processes developed by our Corporate Pilot Labs, develop scaled-up bulk manufacturing procedures for new product launches, transfer, and formula renovations.
* Conduct bench and pilot batches for new and existing formulas to gain an understanding of the bulk physical and chemical properties while trouble-shooting quality problems.
* Manage and execute bulk processing and filling validation projects, including OTC validations, for new formulas and processes.
* Assist with complex troubleshooting bulk related problems in both processing and packaging. Implement process procedure relevant improvements. Conduct activities that support bulk processing productivity and improvement projects.
* Observe "Current Good Manufacturing Practices" (cGMP).
* Support an effective, professional, and communicative work environment with the processing and other departments in the plant.
* Maintain all data, records, and reports.
* Maintain a safe, clean work environment and implement L'Oréal safety and environmental programs.
* Moderate to intermittent supervision, Decisions made in this role have significant impact to plant processing & production
* Perform other duties as necessary or required. Occasional overnight traveling is required
What We Are Looking For:
Required Qualifications:
* Bachelor of Science degree in Chemical Engineering preferred, Chemistry and/or relevant scientific background.
* Three to four years of experience in a relevant bulk manufacturing or process development department.
* Familiarity and knowledgeable in batch manufacturing equipment and process.
* Strong knowledge in MS Office.
* Proven ability to organize, analyze and report data.
What's In It For You:
* Competitive Benefit Package (Medical, Dental, Vision, 401K, Pension Plan)
* Flexible Time Off (Paid Company Holidays, Paid Vacation, Vacation Buy Program, Volunteer Time, Summer Fridays & More!)
* Access to Company Perks (VIP Access to L'Oréal's Internal Shop for Discounted Products, Monthly Mobile Allowance)
* Learning & Development Opportunities for Career Progression (Unlimited Access to E-learnings, Lunch & Learn Sessions, Mentorship Programs, & More!)
* Employee Resource Groups (Think Tanks and Innovation Squads)
* Access to Mental Health & Wellness Programs
Additional Benefits Information As Follows:
Salary Range: $77,775 - $91,500 (The actual compensation will depend on a variety of job-related factors which may include geographic location, work experience, education, and skill level)
Don't meet every single requirement? At L'Oréal, we are dedicated to building a diverse, inclusive, and innovative workplace. If you're excited about this role but your past experience doesn't align perfectly with the qualifications listed in the job description, we encourage you to apply anyways! You may just be the right candidate for this or other roles!
We are an Equal Opportunity Employer and take pride in a diverse environment. We would love to find out more about you as a candidate and do not discriminate in recruitment, hiring, training, promotion, or other employment practices for reasons of race, color, religion, gender, sexual orientation, national origin, age, marital or veteran status, medical condition or disability, or any other legally protected status.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to access job openings or apply for a job on this site as a result of your disability. You can request reasonable accommodations by contacting [email protected]. If you need assistance to accommodate a disability, you may request an accommodation at any time.
Our Safe Together Plan: Your safety is our highest priority. We will proceed with caution and adhere to enhanced protection standards to ensure our sites are safe for all employees. We must all operate with the shared responsibility for each other's health & safety in mind.
Validations Engineer
Quality engineer job in Piscataway, NJ
Job Description
We\'re looking for an individual with experience in validations particularly with USP Water, chiller (utilities) and C&S. Must haves: Experience with drafting and executing IQ/OQ/PQ CAD proficiency to support the update of various P&IDs
Problem solving and troubleshooting skills to be able to identify and resolve issues through the validations
Good Communication and documentation Skills
Knowledge with USP water
Year of Experience: 5+
Major job functions include: generation of qualification / validation documents, execution of qualification / validation documents, generation of reports, adhering to project timelines, ensure compliance with company and industry standards and participating in cross functional teams.
Familiarity with KNEAT ( validation platform) is a plus
Process Engineer 2nd Shift 3 PM to 11 PM
Quality engineer job in Somerset, NJ
Job Description
Process Engineer
Founded in 2000, CompoSecure (NYSE: CMPO) is a technology partner to market leaders, fintechs and consumers, enabling trust for millions of people around the globe. The company combines elegance, simplicity, and security to deliver exceptional experiences and peace of mind in the physical and digital world. CompoSecure's innovative payment card technology and metal cards with Arculus security and authentication capabilities deliver unique, premium branded experiences, enable people to access and use their financial and digital assets, and ensure trust at the point of a transaction. For more information, please visit ******************* and *******************
Position Overview: We are seeking a hands-on and detail-oriented Process Engineer to join our dynamic manufacturing operations team. This role is critical in supporting yield improvement, day-to-day production troubleshooting, and new product introduction (NPI) within a fast-paced 24/7 high-volume production environment. You will work directly on the afternoon shift (3 PM - 11 PM) to ensure optimal performance of processes, effective support to production teams, and smooth onboarding of new products.
This position is an excellent opportunity for engineers looking to make a significant impact in advanced manufacturing operations, supporting blue-chip customers with world-class standards for quality and delivery.
The Process Engineer will be expected to work on-site five days a week in our Somerset, NJ office.
Key Responsibilities:
Provide real-time process support for production teams on the afternoon shift, ensuring minimal downtime and swift issue resolution.
Analyze and improve manufacturing yields, identifying root causes of scrap, rework, and process variation through data-driven methods (e.g., SPC, FMEA, 5 Whys, Fishbone).
Lead or support new product introduction (NPI) activities, including process validation, work instruction development, and ramp-up readiness.
Collaborate with cross-functional teams (Quality, Maintenance, Operations) to drive continuous improvement initiatives focused on cost, efficiency, and throughput.
Develop and maintain standard operating procedures, process documentation, and training materials for manufacturing staff.
Support implementation of Lean manufacturing and Six Sigma techniques to reduce waste and improve process control.
Monitor key performance indicators (KPIs) for yield, cycle time, downtime, and quality, with regular reporting and action planning.
Participate in audits, customer visits, and internal reviews as a technical subject matter expert for assigned process areas.
Ensure compliance with safety, quality, and regulatory standards applicable to manufacturing operations
Other Important Responsibilities:
Consistently demonstrate the ability to prioritize tasks to ensure most critical processes impacting business results are being addressed.
Thorough documentation of existing processes and new process development, inclusive of progressive results, specific equipment parameters and work instructions where appropriate.
Other miscellaneous duties as assigned.
Qualifications:
Bachelor's degree in Manufacturing, Mechanical, Industrial, or Chemical Engineering (or equivalent field).
A minimum of 5 years (or more) of experience in a high-volume manufacturing environment (preferably supporting 24/7 operations).
Proven experience in yield improvement, root cause analysis, and process troubleshooting.
Familiarity with NPI processes, including process validation and production readiness.
Strong working knowledge of Lean, Six Sigma, SPC, and other process control methodologies.
Proficiency with data analysis tools (Excel, Minitab, JMP, etc.) and manufacturing systems (MES, ERP).
Excellent communication and collaboration skills across shifts and cross-functional teams.
Willingness to work on the afternoon shift (3 PM - 11 PM) and occasionally support coverage across other shifts as needed.
Experience in regulated manufacturing (e.g., automotive, aerospace, electronics, or medical device).
Six Sigma Green Belt or Lean certification.
Hands-on experience with automation systems, sensors, or high-throughput equipment.
Physical requirements and work environment:
Must be able to lift 20 lbs;
Must be able to sustain office work for 8+ hours per day including the following:
Sitting in an office chair
Typing
Reaching for the telephone
Standing at office equipment
Hearing for phone use
Sight for computer use
Must be able to sustain factory work as needed including the following:
Standing at machinery
Reaching and pulling to operate machinery
Sight for machinery operation
Walking through shop
Office environment is of moderate noise level.
Shop noise levels are such that protective ear-coverings are recommended.
At CompoSecure, we believe in supporting our employees with a comprehensive benefits package that promotes health, financial well-being, and work-life balance. Our full-time team members enjoy access to:
Medical, Dental & Vision Coverage
Flexible Spending Accounts (FSA)
Company-Paid Life and Disability Insurance
401(k) with Company Match
Paid Time Off & Paid Holidays
Annual Bonus Opportunities
Employee Assistance Program (EAP)
Career Advancement Opportunities
Benefits eligibility and details will be shared during the hiring process. We're excited to support you in building a rewarding career with us.
Please note: CompoSecure does not accept unsolicited resumes from staffing agencies or third-party recruiters. Any unsolicited resumes sent to CompoSecure, including to our employees, will become the property of CompoSecure and may be used without any obligation to pay referral or placement fees. Any agency or recruiter seeking to work with CompoSecure's Talent Acquisition Team should contact our team directly by sending an email to **************************.
CompoSecure is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, or national origin. We are also an equal opportunity employer of individuals with disabilities and protected veterans.
Easy ApplyProcess Engineer
Quality engineer job in New Brunswick, NJ
Associate Process Engineer/Scientist- Drug Product, Biologics Manufacturing Science and Technology Key responsibilities include • Execution of post-market process change activities/experiments through partnership with R&D development assets • Responsible for characterizing, optimizing and troubleshooting product and manufacturing processes of parenteral dosage forms.
• Work with R&D and manufacturing sites to design and execute experiments to support product robustness, new technology implementation, and/or manufacturing investigations
• Serve as technical resource to other functions, providing expertise on the product and its process.
• Effectively represent biologics drug product manufacturing science and technology in various internal and external teams and committees on development, technology transfer, manufacturing, specifications, process validations and launch.
• Provide assistance to sites globally to resolve significant quality events and manage complex change controls.
Qualifications
• Bachelor's degree in relevant science or engineering discipline (chemistry, pharmaceutical sciences, pharmacy, biology, chemical engineering).
• Master or advanced degree preferred.
• Minimum of 3-5 years of experience in the Pharmaceutical or Biotechnology industry in product and process development and commercialization in a global environment.
Key Skills and Experience
• Hands-on experience in the laboratory and in-depth understanding in sterile and liquid products, particularly biologics, formulation development, analytical methods, commercial manufacturing, and their unit operations.
• In-depth understanding of Quality by Design (QbD), Design of Experiments (DOE), multivariate analysis, PAT, critical process and material attributes and CQA's.
• Working competency of Statistical Process Control and related tools (JMP/MiniTab/SAS).
• Able to design and execute scientifically sound, hypothesis driven experiments
• Skilled in writing and reviewing complex study plans and scientific reports.
• Possess high level of familiarity with sterile product processing equipment and manufacturing facilities.
• Overall knowledge of parenteral technology: aseptic processing, sterilization, isolator processing, lyophilization, pre-filled syringe operations, etc.
• Strong understanding of project management systems and tools
• Six Sigma Green/Black Belt certification desirable
Additional Information
Interested candidates may contact at "Praveen.arora(@)artechinfo.com or ************
Continuous Improvement Engineer
Quality engineer job in Warminster, PA
MAIN OBJECTIVES:
Provide support to the Continuous Improvement Engineering Manager in establishing the collection, recording, development, and optimization of KPI metrics for data delivery and analysis, targeted improvement initiatives, cross-functional training, and technical support for the creation of new and the improvement of existing processes. Assist in supporting a culture of Lean Manufacturing in the operations at all Double H facilities through research, observation of production performance, and investigation for opportunities of improvement and established standards.
Assists in collection, documentation, and creation of monthly tracking reports for plant metrics; including production levels, downtime, defect rates, cycle times, OEE, and COPQ. Will complete analysis in performance variances in the aforementioned metrics, using lean manufacturing investigative tools and prepare corrective actions with reports. Maintain and update plant metrics dashboards in Power BI or a similar platform. Assist in the composing of standard work instruction documentation for all positions and assists HR teams in developing and maintaining training matrix for new employee onboarding.
PRIMARY DUTIES AND RESPONSIBILITIES: Follow and promote the company's safety-first culture through proper execution and monitoring of safety procedures; including the use of all safety equipment, personal protective gear, and safety glasses (where applicable). Stops and reports ALL unsafe activities immediately.
Assist Continuous Improvement Manager in effective process evaluation, root cause analysis, corrective actions and failure analysis. Monitor scrap and waste levels for all lines and help drive reductions in waste to increase output and maximize uptime.
Project research and data recording, including: time-studies, work flow analysis, machine metrics, ergonomics and employee movements.
Develop automated spreadsheets, interactive user-forms, and dashboards using Power BI or similar tools.
Track metrics for line startup, changeovers, preventative maintenance, safety initiatives, and employee performance to evaluate the effectiveness of process changes.
Author and edit standard work instructions and single point lessons. Work with plant managers or teams to develop and train employees.
CRITICAL KPI'S:
C andidate will be measured on completion, quantity, and quality of assigned work.
Maintenance of on demand data and accuracy of the data presented.
Generation of cost saving and waste removal projects, production increases, scrap reduction and performance improvement of the plants.
Ability to work across all plants and managers to a satisfactory experience and performance level.
QUALIFICATIONS:
Education:
Associates or Bachelor's Degree in Engineering (Industrial, Manufacturing, Mechanical, Plastics, or Electrical)
Required knowledge:
Manufacturing process control
Lean Manufacturing or Six Sigma
Engineering principles (Math and Mechanical aptitude)
An ideal candidate will be/have:
Self-motivated - able to complete tasks with little assistance, choosing to do things the right way even when it takes longer or there is pressure to take shortcuts.
Extremely organized with high attention to details.
Strong written and oral communication skills.
Bold and take the initiative to act.
2-3 years of manufacturing experience.
Creativity when data collecting and problem solving.
Good interpersonal skills - comfortable speaking with, training, and interacting with people at all levels of the organization on a daily basis.
Inclusive of all ideas, and able to navigate multi-cultural/multi-language teams.
Skills/Abilities:
Strong MS Excel skills at the complex formula, advance charting, pivot table level. Visual Basic or other coding language a plus.
Strong skills in MS Teams, Power BI, DOMO or similar visual display software.
Knowledge of Pareto, 5-Why, 8D, Ishikawa (Fishbone) diagram, root cause analysis.
#IND1
Auto-ApplyValidation Engineer
Quality engineer job in Newtown, PA
Job DescriptionRole Purpose: Validation Engineer:Support site commissioning and qualification, which includes but is not limited to the following: equipment, utilities, cleaning, process, assay qualifications. Ensuring the timely development, execution, and coordination of all validation activities pertaining to facility, equipment, and process in compliance with Quality System requirements, site procedures and regulatory requirements. This role will develop validation and Quality System documentation (e.g., IQ/OQ/PQ/SOP/Change Controls/Deviations/CAPAs etc.). This role will organize all validation activities ensuring project completion per schedule requirements.
Key Duties & Responsibilities: Validation Engineer:
Maintain the Company's compliance with established PLS Standard Operating Procedures and specifications and Current Good Manufacturing Practices.
Write, execute and coordinate commissioning, qualification and validation protocol testing.
Compile relevant commissioning/qualification/validation study data and generate summary reports to document the results of the studies.
Aid in troubleshooting/impact assessment for atypical conditions during studies/ validations.
Assist in the maintenance and development of any existing validation programs to ensure continued compliance with regulatory requirements.
Provide scientific rationale/strategy for studies of new or modified GMP equipment and processes.
Ensure all aspects of validation and qualification adhere to site and corporate policies and procedures, including safety and training.
Review all errors, protocol deviations, and comments with the respective user department Management and QA and resolve discrepancies.
Manage responsibilities and workload to assure accurate and timely data and reports.
Initiate Change Controls in order to support validations in accordance with QMS processes.
Perform investigations as needed to support QMS Deviation/CAPA processes.
Implement Corrective/Preventive Actions related QMS CAPA processes which may require validation activities.
Review completed validation, PM, and calibration documentation for accuracy and GMP compliance.
Comply with FDA guidelines, Site and Corporate Policies for Data Integrity.
Technical Supervisory Responsibilities: Validation Engineer:
Ability to manage and plan multiple projects.
Knowledge of cGMP's, GDP's and regulatory requirements as they related to qualification and validation activities (IQ/OQ/PQ).
Possess a working knowledge of Microsoft Word, Windows, Excel, Power Point, and Statistical tools such as Minitab/Jmp.
Must possess excellent analytical skills, good problem-solving technique and data analysis skills using Excel.
Employee must have excellent communication skills, both written and verbal
Employee must be collaborative when working with groups.
Attention to detail is required.
Onsite Personnel is an equal opportunity employer committed to hiring a diverse workforce in an inclusive culture environment. Onsite Personnel does not discriminate based on disability, veteran status or any other basis protected under federal, state, or local laws.
Manufacturing Eng Trainee
Quality engineer job in Trenton, NJ
This is an entry level position in manufacturing engineering as part of our manufacturing training and development program. This position will provide an excellent developmental opportunity in operations and manufacturing combined with practical hands on projects contributing directly to the performance and success of the company. Position will include a mentor-ship and corporate exposure.
Responsibilities Include:
Provide technical support in the areas of bearing design, design improvements, customer support, production support and review of new applications.
Analyze engineering/design loading problems.
Able to work hands on
Provide technical solutions to ensure product performance.
Responsible for the conceptual design engineering of new products, special products and contribute to the improvement of existing products and manufacturing methods to meet customer demands.
Required Education, Skills and Experience:
Bachelor's Degree in Engineering
Must be a U.S. Citizen
Attendance and punctuality at work are essential functions of this position.
Preferred Education, Skills and Experience:
Experience/working knowledge of manufacturing processes
Ability to read and decipher manufacturing drawings and procedures
Intermediate materials knowledge
Working knowledge of solid modeling
We offer competitive compensation and excellent benefits including Medical, Dental, and company matched 401k plan.
RBC Bearings is an Equal Opportunity Employer, including disability and protected veteran status.
Industrial Engineer
Quality engineer job in High Bridge, NJ
The Industrial Engineer is responsible for driving continuous improvement across plant operations, with a focus on efficiency, productivity, and safety. Spending approximately 85% of their time on the floor, this role partners closely with production, maintenance, and engineering teams to streamline processes, implement best practices, and identify opportunities for equipment upgrades or modifications. The Industrial Engineer also develops and standardizes SOPs, ensuring consistency and compliance throughout the plant.
Responsibilities
Analyze and improve production processes to reduce waste, downtime, and costs while increasing efficiency and quality.
Develop, implement, and update Standard Operating Procedures (SOPs) for plant operations.
Partner with maintenance and engineering teams to recommend and support equipment upgrades, modifications, or replacements.
Conduct time studies, workflow analysis, and root cause investigations to support process improvements.
Monitor key performance metrics and provide data-driven recommendations for efficiency improvements.
Support safety initiatives through process evaluation, ergonomic studies, and risk assessments.
Provide training and guidance to production staff on improved processes and SOP adherence.
Collaborate with leadership to identify and implement lean manufacturing and continuous improvement initiatives.
Assist with capital projects by providing engineering input, ROI analysis, and implementation support.
Perform additional duties as assigned.
Qualifications
Strong knowledge of lean manufacturing principles, continuous improvement methods, and workflow analysis.
Familiar with natural gas furnaces, hydraulic systems, high voltage motors and large displacement pumps.
Proficiency in Microsoft Office and CAD software (AutoCAD or similar preferred).
Excellent communication and collaboration skills for working with cross-functional teams.
Ability to spend extended time on the plant floor observing, analyzing, and improving processes.
Knowledge of business principles, strategic planning, and resource allocation.
Familiar with quality systems such as ISO 9001.
Education and/or Experience
Bachelor's degree in Industrial Engineering, Mechanical Engineering, or other related engineering fields.
Journeyman-level experience in a manufacturing/industrial setting may be considered in lieu of a degree.
5+ years of industrial, process, or manufacturing engineering experience.
Preferred Experience in natural gas furnaces, hydraulic systems, high voltage motors and large displacement pumps.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands and fingers to handle or feel and talk or hear. The employee is frequently required to sit. The employee is occasionally required to walk; reach with hands and arms and stoop, kneel, crouch, or crawl. The employee is occasionally required to lift up to 100 pounds. The vision requirements include close vision, distance vision, peripheral vision, depth perception and ability to adjust focus.
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment can vary.
Trident Maritime Systems is an EEO/AA employer that offers a comprehensive compensation package and opportunities for growth.
As a government contractor, we adhere to regulations including the need for U.S. citizenship for certain positions.
Offers of employment are contingent on and not considered finalized until the required background check and drug test has been performed and the results received and have been accessed.
About Trident Maritime Systems - Custom Alloy Division
Trident Maritime Systems is a global leader in providing innovative solutions for maritime and defense industries. Our Custom Alloy division in High Bridge, NJ, specializes in manufacturing high-quality seamless and welded pipe and tube solutions, as well as custom fabrications for critical applications. We serve government and commercial clients. For government, we work on military and defense contracts requiring precision and reliability. For commercial clients, we provide custom-engineered solutions across various industries. This dual focus allows us to take on diverse, high-pressure projects. Unlike mass production facilities, we create large, custom fittings tailored to specific needs. Our plant features large machines for heavy-duty work in a traditional manufacturing environment. It can be hot, cold, or dirty, but we prioritize safety and provide tools and training to ensure success.
Trident Maritime Systems offers a comprehensive benefit package which includes:
Cigna medical, dental; VSP vision.
Flexible Spending Account & Health Savings Account (with company contributions)
401K
Paid Time Off
10 Paid Holidays
Safety shoe reimbursement, $200 per year
Prescription safety glasses program
Voluntary Supplemental Insurance
Company Paid Life Insurance
Voluntary Life Insurance
Paid training and development opportunities
Employee referral program
Onsite M - F 8 am - 5 pm
Auto-ApplyProcess Engineer
Quality engineer job in Warminster, PA
The Process Engineer role will support the Castrol Warminster facility operations, providing process optimization/ continuous improvement and process safety rigor expertise for the plant. This role will be responsible for the equipment and systems at the production facility.
This includes designing and modifying new and current processes, working with technology and procurement to implement new products and materials, as well as improving production output and equipment uptime.
This role will work with the Lead Plant Engineer and Capital Projects Engineer to help better optimize the plant processes and advise or lead the implementation of new processes.
Key Accountabilities Works with key interested parties (engineer/capex/technology) to develop new processes for the operations.
Optimizes existing equipment and implement enhancements to productivity, cost efficiency and improving product quality.
Responsible for continuous improvement and optimization of current manufacturing processes to ensure safety and quality standards are met.
Reviews and assess current processes through data collection and operator inputs to identify and target bottlenecks of the process for improvement.
Responsible for existing process control systems in maintaining, solving and improvements in the software.
Will work the local engineering team to implement new software, systems, and designs that align with the plant needs and consistency with other plant systems.
Works with the operations team to understand & resolve any production bottlenecks or system issues to prevent further failures.
Collaborates with local and business partners including product technology and network ops teams for introduction of new processes and modification/scale of existing to ensure the site can meet the requirements.
Works with HSSE Manager to ensure all engineering, maintenance, contractors, and other technical functions are driven in compliance with HSSE standards.
Ensures the MOC (Management of Change process) is rigorously adhered to for maintenance changes.
Ensures consistent implementation of all applicable BP and SPU engineering policies, practices and guidelines at the Plant level.
Develops a "customer Service" mind set within the team.
Maintains a strong connectivity to Regional Engineering NetworkUnderstands and ensures compliance with the global policies and procedures for addressing Process Safety Risks at the sites.
Ensures process safety compliance by using the Non-normative Blend Plant Process checklist to identify where PHA's are required and coordinates the PHA revalidation process.
Legal Compliance Task Owner is responsible for maintaining full compliance with all applicable legal and regulatory requirements associated with job accountabilities.
Act as BP Contract Accountable Manager to ensure safe execution of the contracted work while applying the Working with Contractor process throughout for CAPEX and Maintenance.
Supports the plant's control of work policy and participates in the program.
Education: Bachelor's degree in engineering required (Chemical & Mechanical Preferred, Other with relevant experience) Essential Experience and Job Requirements: Provides process optimization/ continuous improvement expertise, and process safety discipline leadership (i.
e.
mitigate hazards and reduce operational risk) during the conceptualization, development and design of new projects and plant improvement initiatives Supports the OMS Sub-elements (3.
3 Process Safety, 5.
2 Design & Construction, 5.
3 Asset Operation, 5.
4 Inspection and Maintenance) Implementation.
Develops and applies project specifications which are consistent with bp's policies, processes and engineering expectations, for controlling the quality/Conduct assurance audits as requested Ensures that assets/equipment/systems operate within the specified design parameters accounting for variability in product and operating characteristics Ensures that the process operates to deliver quality, safety and environmental objectives Leads Process safety reviews, risk assessments and action item resolution plans to mitigate safety hazards and reduce operational risks Support the greater Castrol Americas business and Americas GSC by participating in cross functional teams to optimize the manufacturing operations and support customer delivery.
Takes part in Process safety reviews, risk assessments and action item resolution plans to mitigate safety hazards and reduce operational risks Provides process & operational optimization/ continuous improvement expertise, and process safety field leadership (i.
e.
mitigate hazards and reduce operational risk) during the conceptualization, development and design of new projects and plant improvement initiatives Must demonstrate awareness of engineering principles, practices and methods, environmental regulations, engineering project management methods, workplace safety, budgeting, employee supervision and personnel management.
Experience with supporting Engineering projects at all stages of ideation, scoping, conceptual design, detail design, project execution, project commissioning, project turn-over.
Experience with leading diverse teams (members may include operations, logistics, planning, marketing, technology) on engineering/CAPEX projects Experience with HAZOP/HAZID participation Desirable criteria:Effective Communicator: Able to present complex problems to a wide range of audiences in a concise, accurate, and coherent manner.
Effectively demonstrate and translate the business impact and value proposition of a recommendation to the entire organization.
Excellent organizational skills Why join us At bp, we support our people to learn and grow in a diverse and ambitious environment.
We believe that our team is strengthened by diversity.
We are committed to fostering an inclusive environment in which everyone is respected and treated fairly.
There are many aspects of our employees' lives that are meaningful, so we offer benefits ( ****************************
com/landing.
html) to enable your work to fit with your life.
These benefits can include flexible working options, a generous paid parental leave policy, and excellent retirement benefits, among others! 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.
Journeyman Materials Engineer
Quality engineer job in Lakehurst, NJ
Andromeda Systems Incorporated (ASI) is seeking a full-time Journeyman Materials Engineer to support Environment, Safety, and Occupational Health (ESOH) factors within NAVAIR acquisition programs. Responsibilities: * Conduct assessments and analyses of Environment, Safety, and Occupational Health (ESOH) factors within NAVAIR acquisition and sustainment programs
* Create and maintain ESOH documents to support risk management and program compliance throughout the life cycle
* Conduct environmental reviews and prepare required documentation, including Records of Categorical Exclusion
* Review acquisition documentation to ensure compliance with ESOH regulations and best practices; incorporate ESOH requirements into specifications and statements of work
* Support and review Hazardous Material Management Program (HMMP) Plans, Reports, System Safety Program Plans, and Safety Analysis Reports
* Participate in program meetings and reviews to assess ESOH impacts and support development of mitigation strategies to reduce technical, schedule, and cost risks
* Assess and analyze materials engineering data to provide recommendations for materials and processes in support of acquisition, sustainment, and Fleet operations
* Develop material requirements for new programs and evaluate engineering changes for existing systems; consult with design engineers on material and process selections
* Recommend materials, coatings, and corrosion prevention systems based on performance and usage requirements
* Provide guidance on material processes including welding, heat treatment, electroplating, thermal spray, surface treatments, and non-destructive testing
* Review and analyze engineering drawings for material specification accuracy and suitability; assess proposed materials for Fleet applications and maintenance
* Support testing of material characteristics using established or custom standards; document results in formal reports with data analysis and recommendations
* Assist in qualifying materials for Fleet operational equipment and provide technical support for manufacturing and repairing Fleet assets
* Review formal engineering reports and document findings related to materials and ESOH compliance
Required Qualifications:
* Bachelors degree in materials engineering, chemistry, chemical engineering, mechanical engineering, or related scientific/technical discipline from an ABET accredited college or university
* At least 3 years of experience in materials engineering or ESOH support within defense acquisition
* Familiarity with MIL-STD-882E and NAS 411/411-1 standards
* Ability to evaluate hazardous materials and recommend ways to reduce risks and ensure compliance
* Experience selecting materials, coatings, and processes for performance and corrosion protection
* Skilled in reading and interpreting engineering drawings and specifications
* Strong analytical and problem-solving abilities
* Effective technical writing skills for reports and documentation
* Comfortable working with cross-functional teams and participating in program reviews
Preferred Qualifications:
* Experience supporting NAVAIR or other DoD acquisition programs
* Knowledge of hazardous materials management and pollution prevention strategies
* Familiarity with lifecycle logistics, systems engineering, and demilitarization/disposal processes
* Experience with composite and nanomaterial development and testing
At ASI, we understand that everyones journey is different. If you are not sure if your experience meets the requirements, we encourage you to apply. We are interested in what you have to offer.
Work Authorization/Security Clearance:
* Must be a U.S. Citizen and qualify for Secret Clearance
Benefits and Compensation:
* 401(k) plan with immediate 100% vesting and 4% discretionary match
* Paid leave including PTO, holiday, bereavement, and military
* Generous medical, dental, and vision insurance for employees and their families
* Health and dependent care FSA
* Company-provided life/AD&D, as well as supplemental life and disability insurance
* TRICARE Supplement
* Employee Assistance Program
* Tuition assistance and professional development
* Bonus programs
Pay:
* $35-$67 per hour
Andromeda Systems Incorporated (ASI) provides tools and services to assist Physical Asset Owners, Fleet Managers, and Military Program Managers in gaining critical insights into their equipments performance, identifying system improvements, optimizing operations and support, making better business decisions, and achieving measurable life-cycle cost savings.
ASI provides unparalleled expertise and capabilities in the Reliability, Maintenance, Supportability, and Logistics disciplines. Our staff of internationally recognized leaders are shaping the industry and developing revolutionary solutions in the military and commercial sectors. Clients leverage our experience and cutting-edge analytical tools to improve asset performance and reduce life-cycle costs. As a leading provider of professional and high technology services and solutions, ASI serves the Department of Defense, U.S. civilian agencies, and private industry.
For more information about this and other open positions, please visit our website at ********************
AAP/EEO Statement
Andromeda Systems Incorporated is an Equal Employment Opportunity employer. As such, 41 CFR 60-1.4(a), 41 CFR 60-300.5, 41 CFR 60-741.5 as well as 29 CFR Part 471, Appendix A to Subpart A are herein incorporated by reference, to the extent applicable.
This contractor and subcontractor shall abide by the requirements of 41 CFR 60-1.4(a), 60-300.5(a) and 60-741.5(a). These regulations prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities, and prohibit discrimination against all individuals based on their race, color, religion, sex, sexual orientation, gender identity or national origin. Moreover, these regulations require that covered prime contractors and subcontractors take affirmative action to employ and advance in employment individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
Process Engineer
Quality engineer job in Piscataway, NJ
Process Engineer reports to the Manager of Technical Services and plans, executes and functionally directs Process/Cleaning Validation/Study assignments and projects, which require sound pharmaceutical/engineering skills and independent judgment. Works as a team member, educates internal partners on the projects, monitors and executes. Maintains effective and cooperative relationships with all departments within and outside the organization. Managing the post approval projects.
Essential Functions:
Prepare validation protocols & reports for manufacturing process and cleaning process qualification, data analysisand prepare reports; execute the manufacturing process and cleaning process qualification/validation/study.
Managing the post approval projects. coordinating with cross functional Teams and ensuring the timely completion of projects.
Analyzes statistical data, products or functional specifications to determine conformance with standards andestablished quality requirements
Coordinate/oversee the development of new processes or troubleshoot existing ones
Assist in deviation/investigations to identify root causes and define corrective and/or preventative actions (CAPA) & assist in various audits
Additional Responsibilities:
Initiation of Change Controls and Planned Deviations when required
Education:
Bachelors Degree (BA/BS) Pharmaceutical/Biomedical Engineering - Required
Master Degree (MS/MA) Pharmaceutical/Biomedical Engineering - Preferred
Experience:
2 years or more in Pharmaceutical/Manufacturing Industry
Skills:
Excellent verbal and written communication skills - Advanced
Proficiency in MS Word/Excel/ PowerPoint/MS project - Advanced
Specialized Knowledge:
Basic Analytical Knowledge desirable. In-depth knowledge of manufacturing equipment and processes for Solid Oral, Medical Device, Transdermal, Topical and Liquid Orals.
The salary for this position ranges from $80,000 to $95,000. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, as well as a long-term incentive award, such as restricted stock units, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.
Auto-ApplyProcess Engineer 2nd Shift 3 PM to 11 PM
Quality engineer job in Somerset, NJ
Process Engineer
Founded in 2000, CompoSecure (NYSE: CMPO) is a technology partner to market leaders, fintechs and consumers, enabling trust for millions of people around the globe. The company combines elegance, simplicity, and security to deliver exceptional experiences and peace of mind in the physical and digital world. CompoSecure's innovative payment card technology and metal cards with Arculus security and authentication capabilities deliver unique, premium branded experiences, enable people to access and use their financial and digital assets, and ensure trust at the point of a transaction. For more information, please visit ******************* and *******************
Position Overview: We are seeking a hands-on and detail-oriented Process Engineer to join our dynamic manufacturing operations team. This role is critical in supporting yield improvement, day-to-day production troubleshooting, and new product introduction (NPI) within a fast-paced 24/7 high-volume production environment. You will work directly on the afternoon shift (3 PM - 11 PM) to ensure optimal performance of processes, effective support to production teams, and smooth onboarding of new products.
This position is an excellent opportunity for engineers looking to make a significant impact in advanced manufacturing operations, supporting blue-chip customers with world-class standards for quality and delivery.
The Process Engineer will be expected to work on-site five days a week in our Somerset, NJ office.
Key Responsibilities:
Provide real-time process support for production teams on the afternoon shift, ensuring minimal downtime and swift issue resolution.
Analyze and improve manufacturing yields, identifying root causes of scrap, rework, and process variation through data-driven methods (e.g., SPC, FMEA, 5 Whys, Fishbone).
Lead or support new product introduction (NPI) activities, including process validation, work instruction development, and ramp-up readiness.
Collaborate with cross-functional teams (Quality, Maintenance, Operations) to drive continuous improvement initiatives focused on cost, efficiency, and throughput.
Develop and maintain standard operating procedures, process documentation, and training materials for manufacturing staff.
Support implementation of Lean manufacturing and Six Sigma techniques to reduce waste and improve process control.
Monitor key performance indicators (KPIs) for yield, cycle time, downtime, and quality, with regular reporting and action planning.
Participate in audits, customer visits, and internal reviews as a technical subject matter expert for assigned process areas.
Ensure compliance with safety, quality, and regulatory standards applicable to manufacturing operations
Other Important Responsibilities:
Consistently demonstrate the ability to prioritize tasks to ensure most critical processes impacting business results are being addressed.
Thorough documentation of existing processes and new process development, inclusive of progressive results, specific equipment parameters and work instructions where appropriate.
Other miscellaneous duties as assigned.
Qualifications:
Bachelor's degree in Manufacturing, Mechanical, Industrial, or Chemical Engineering (or equivalent field).
A minimum of 5 years (or more) of experience in a high-volume manufacturing environment (preferably supporting 24/7 operations).
Proven experience in yield improvement, root cause analysis, and process troubleshooting.
Familiarity with NPI processes, including process validation and production readiness.
Strong working knowledge of Lean, Six Sigma, SPC, and other process control methodologies.
Proficiency with data analysis tools (Excel, Minitab, JMP, etc.) and manufacturing systems (MES, ERP).
Excellent communication and collaboration skills across shifts and cross-functional teams.
Willingness to work on the afternoon shift (3 PM - 11 PM) and occasionally support coverage across other shifts as needed.
Experience in regulated manufacturing (e.g., automotive, aerospace, electronics, or medical device).
Six Sigma Green Belt or Lean certification.
Hands-on experience with automation systems, sensors, or high-throughput equipment.
Physical requirements and work environment:
Must be able to lift 20 lbs;
Must be able to sustain office work for 8+ hours per day including the following:
Sitting in an office chair
Typing
Reaching for the telephone
Standing at office equipment
Hearing for phone use
Sight for computer use
Must be able to sustain factory work as needed including the following:
Standing at machinery
Reaching and pulling to operate machinery
Sight for machinery operation
Walking through shop
Office environment is of moderate noise level.
Shop noise levels are such that protective ear-coverings are recommended.
At CompoSecure, we believe in supporting our employees with a comprehensive benefits package that promotes health, financial well-being, and work-life balance. Our full-time team members enjoy access to:
Medical, Dental & Vision Coverage
Flexible Spending Accounts (FSA)
Company-Paid Life and Disability Insurance
401(k) with Company Match
Paid Time Off & Paid Holidays
Annual Bonus Opportunities
Employee Assistance Program (EAP)
Career Advancement Opportunities
Benefits eligibility and details will be shared during the hiring process. We're excited to support you in building a rewarding career with us.
Please note: CompoSecure does not accept unsolicited resumes from staffing agencies or third-party recruiters. Any unsolicited resumes sent to CompoSecure, including to our employees, will become the property of CompoSecure and may be used without any obligation to pay referral or placement fees. Any agency or recruiter seeking to work with CompoSecure's Talent Acquisition Team should contact our team directly by sending an email to **************************.
CompoSecure is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, or national origin. We are also an equal opportunity employer of individuals with disabilities and protected veterans.
Easy ApplyProcess Engineer
Quality engineer job in New Brunswick, NJ
Associate Process Engineer/Scientist- Drug Product, Biologics Manufacturing Science and Technology
Key responsibilities include • Execution of post-market process change activities/experiments through partnership with R&D development assets
• Responsible for characterizing, optimizing and troubleshooting product and manufacturing processes of parenteral dosage forms.
• Work with R&D and manufacturing sites to design and execute experiments to support product robustness, new technology implementation, and/or manufacturing investigations
• Serve as technical resource to other functions, providing expertise on the product and its process.
• Effectively represent biologics drug product manufacturing science and technology in various internal and external teams and committees on development, technology transfer, manufacturing, specifications, process validations and launch.
• Provide assistance to sites globally to resolve significant quality events and manage complex change controls.
Qualifications
• Bachelor's degree in relevant science or engineering discipline (chemistry, pharmaceutical sciences, pharmacy, biology, chemical engineering).
• Master or advanced degree preferred.
• Minimum of 3-5 years of experience in the Pharmaceutical or Biotechnology industry in product and process development and commercialization in a global environment.
Key Skills and Experience
• Hands-on experience in the laboratory and in-depth understanding in sterile and liquid products, particularly biologics, formulation development, analytical methods, commercial manufacturing, and their unit operations.
• In-depth understanding of Quality by Design (QbD), Design of Experiments (DOE), multivariate analysis, PAT, critical process and material attributes and CQA's.
• Working competency of Statistical Process Control and related tools (JMP/MiniTab/SAS).
• Able to design and execute scientifically sound, hypothesis driven experiments
• Skilled in writing and reviewing complex study plans and scientific reports.
• Possess high level of familiarity with sterile product processing equipment and manufacturing facilities.
• Overall knowledge of parenteral technology: aseptic processing, sterilization, isolator processing, lyophilization, pre-filled syringe operations, etc.
• Strong understanding of project management systems and tools
• Six Sigma Green/Black Belt certification desirable
Additional Information
Interested candidates may contact at "Praveen.arora(@)artechinfo.com or ************
Process Engineer
Quality engineer job in Piscataway, NJ
Process Engineer reports to the Manager of Technical Services and plans, executes and functionally directs Process/Cleaning Validation/Study assignments and projects, which require sound pharmaceutical/engineering skills and independent judgment. Works as a team member, educates internal partners on the projects, monitors and executes. Maintains effective and cooperative relationships with all departments within and outside the organization. Managing the post approval projects.
Essential Functions:
* Prepare validation protocols & reports for manufacturing process and cleaning process qualification, data analysisand prepare reports; execute the manufacturing process and cleaning process qualification/validation/study.
* Managing the post approval projects. coordinating with cross functional Teams and ensuring the timely completion of projects.
* Analyzes statistical data, products or functional specifications to determine conformance with standards andestablished quality requirements
* Coordinate/oversee the development of new processes or troubleshoot existing ones
* Assist in deviation/investigations to identify root causes and define corrective and/or preventative actions (CAPA) & assist in various audits
Additional Responsibilities:
* Initiation of Change Controls and Planned Deviations when required
Auto-Apply