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Full-time
bachelor degree
Posted 17d ago
~40 hrs/week
Responsibilities
The Manufacturing Engineer will design, optimize, and troubleshoot pharmaceutical packaging processes to ensure high-quality production. They will also lead cross-functional teams in process improvements and ensure compliance with GMP and FDA regulatory standards.
Requirements
Candidates must hold a bachelor's degree in Mechanical, Chemical, or Pharmaceutical Engineering and possess at least 3 years of relevant manufacturing experience. Proficiency in engineering software and a strong understanding of regulated manufacturing environments are required.
Full job description
Our work truly matters and our resourcefulness can make all the difference in getting life-saving drugs to the people who need them, when they need them. We’re more efficient and effective when we’re not overly bound to a set way of working. Bring your resourcefulness and agility to continue your career at Sharp.
The Manufacturing Engineer will play a crucial role in the design, optimization, and troubleshooting of manufacturing processes to ensure efficient, safe, and high-quality production of pharmaceutical products. This position requires hands on trouble shooting of electromechanical packaging equipment. This position involves close collaboration with cross-functional teams to support process improvement, compliance with regulatory requirements, and continuous improvement in a highly regulated environment.
Key Responsibilities: • Process Optimization: Design, develop, and implement processes to improve manufacturing efficiency, reduce waste, and enhance product quality. Troubleshoot and resolve production issues to minimize downtime and ensure smooth operations. • Equipment and Technology Management: Evaluate, select, and oversee the installation and maintenance of manufacturing equipment, ensuring they are functioning according to specifications and industry standards. • Compliance and Documentation: Ensure all manufacturing activities comply with Good Manufacturing Practices (GMP), FDA regulations, and other relevant standards. Maintain accurate records, reports, and documentation in accordance with regulatory guidelines. • Author technical documents such as Change Controls and WRKI’s, Review MPR’s etc. • Quality Control and Assurance: Collaborate with quality assurance teams to identify and implement corrective actions, conduct root cause analysis for quality issues, and ensure continuous product quality in the production process. • Project Management: Lead or participate in cross-functional teams for process improvement, facility upgrades, or new product introduction projects. Provide technical guidance on new product development and scale-up processes. • Training and Support: Train and mentor operators and technicians on new processes, equipment, and safety procedures to ensure effective and efficient production workflows.
Continuous Improvement: Identify opportunities for process automation, cost reduction, and other performance improvements. Foster a culture of continuous improvement using Lean, Six Sigma, or similar methodologies. • Troubleshooting: Provide engineering support during production to resolve mechanical, electrical, or process-related problems in a timely manner. • Safety and Risk Management: Promote a safe working environment by adhering to health and safety protocols and identifying any potential risks or hazards in the manufacturing processes.
Required Qualifications: • Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Pharmaceutical Engineering, or a related field. (Degree in progress will be considered) • 3+ years of experience in a manufacturing engineering role, preferably within the pharmaceutical or life sciences industry. • Strong understanding of pharmaceutical manufacturing processes, equipment, and regulatory requirements (FDA, GMP, etc.). • Experience with process design, process control, and equipment validation in a regulated manufacturing environment. • Proficiency in the use of engineering software, such as AutoCAD, SolidWorks, or process simulation tools. • Familiarity with Lean Manufacturing, Six Sigma, or similar continuous improvement methodologies.
Related keywords
Manufacturing EngineeringPharmaceuticalLife SciencesProcess OptimizationTroubleshootingElectromechanicalPackaging EquipmentGMPFDAChange ControlsWRKIMPRQuality AssuranceRoot Cause AnalysisProject ManagementScale-up
A specialist CDMO delivering commercial packaging, clinical trial and sterile manufacturing services
Industry
Pharmaceutical Manufacturing
Company size
1,001-5,000 employees
Headquarters
Allentown, PA
LinkedIn followers
17,634
Total funding
$713M
Sharp is a leader in commercial packaging, clinical services & sterile manufacturing. For 70+ years, we’ve provided solutions to pharma & biotech clients from preclinical through to commercial launch & lifecycle management. With facilities in the United States, United Kingdom, Belgium & the Netherlands and 30+ clinical depots globally, covering every region of the world, our experience is your strength.
Our full complement of integrated services includes research and development, clinical manufacturing, sterile development and fill/finish services, primary and secondary packaging of both investigational and commercial product, package design, serialization and aggregation, storage, distribution and clinical IRT. Sharp also offers Qualified Person (QP) services to meet the complex regulatory demands of drug product release in the EU and UK.
Offices: 7451 Keebler Way, Allentown, PA 18106, US · Unit 28, Heol Klockner, Heads of the Valleys Ind Est, Rhymney, Wales NP225RL , GB · 23 Carland Rd, Conshohocken, Pennsylvania 19428, US · 2400 Baglyos Circle, Bethlehem Township, Pennsylvania 18020, US · Klöcknerstraat 1 b, Hamont, Flemish Region 3930, BE
How many Engineering jobs are open in Allentown, PA right now?
There are currently 305 open engineering positions in Allentown, PA listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Engineering roles in Allentown, PA?
Companies currently hiring include LG&E and KU Energy LLC, Thermo Fisher Scientific, Air Products, Sharp Packaging Solutions, part of UDG Healthcare plc, JMT, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Engineering jobs in Allentown, PA?
Yes — 51 of the 305 open engineering positions offer remote or hybrid work (8 remote, 43 hybrid).
How do I apply for Engineering jobs in Allentown, PA?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.