Engineering Jobs in Pa Remote

The Senior Advanced Manufacturing Engineer will work with internal stakeholders and outside contractors to execute projects to support manufacturing scale up. This will require managing medium to large scale projects from concept, through capital funding planning and approval, and ultimately through successful implementation of automation and facility projects to meet the goals of the business.

Responsibilities

• Demonstrated ability to effectively work with suppliers, outside contractors and stakeholders and recommend development of best practices to improve assembly/manufacturing methods and procedures.
• Impacts the achievement of part design related to design for assembly/manufacturing, error proofing, fixture design, and incorporating quality monitoring and improvement measures to drive results.
• Works independently and as part of a team on complex projects.
• Collaborate with partner groups in development and review of manufacturing process for new products, design changes, or new manufacturing methods.
• Recommend, evaluate, and implement new technologies to improve efficiency or enhance flexibility of manufacturing operations with a focus on launch site capability.
• Partner with leadership, operations and engineering teams to ensure that new equipment projects align with the manufacturing strategy and build plans.
• Be accountable to deliver operability, reliability, and functional integrity of automated manufacturing equipment for handover to operations.
• Lead facility expansion efforts to support scaling of manufacturing sites, new and existing.

Education and Experience

• Bachelor's degree in engineering preferred
• Minimum of 10 years' experience
• Experience and understanding of complex automated manufacturing systems and components (electrical and pneumatic control, PLC and HMI devices, sensors, servo motors, vision systems, and robotics)
• Good understanding of supporting processes associated with the operations and maintenance of a production plant.
• Experience in manufacturing engineering and plant operations with direct experience in automated production processes, equipment support, and manufacturing best practices.
• Proficiency in use of AutoCAD

Travel

• Overnight/North America: Less than 10%

Working Conditions

• Office Environment - Must be able to remain in a stationary position 50% of the time and occasionally move about inside the office to access file cabinets, office machinery, etc. Required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading. May be required to exert up to 25 pounds of force occasionally to lift, carry, push, pull or otherwise move objects, including the human body.
• Factory - The worker may be subject to hazards. Includes a variety of physical conditions, such as proximity to moving mechanical parts, vibration, moving vehicles, electrical current, exposure to temperature changes or exposure to chemicals. While performing the duties of this job, the employee may be exposed to fumes, airborne particles, odors, dust, mists, and gases. The noise level in the work environment can be loud. Required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes. Machinery operation requires the use of safety equipment to include but not limited to eye safety glasses, hearing protectors, work boots, and lab coats. May be required to exert up to 35 pounds of force occasionally to lift, carry, push, pull or otherwise move objects, including the human body.

For 80 years, Winholt Equipment has been a leading USA manufacturer with a global supply chain offering innovation, experience, quality products, and trusted service. We focus on building strong, cohesive teamwork to achieve the future success of our company. We are proud of our reputation of engineering excellence, product innovation, and responsive customer service.

We continue to grow and are seeking an experienced and results-driven Manufacturing Manager to lead and optimize our manufacturing facility in Allentown, PA. This leadership role reports directly to the Vice President of Operations and plays a key part in driving production output, quality, efficiency, and profitability across all departments.

Responsibilities:

• Lead daily operations across all fabrication areas, including stainless steel, aluminum, and steel production—Welding (MIG/TIG), Cutting/Punching, Forming/Bending, Final Assembly, and Inspection.
• Develop and execute production plans using the Company’s ERP system to meet customer demand and shipping schedules.
• Drive performance to achieve sales and output goals, ensuring production targets align with company growth objectives.
• Monitor capacity, manpower, and resource allocation, recommending and implementing adjustments to optimize throughput.
• Evaluate and recommend capital equipment investments, develop CapEx plans, and support ROI justification.
• Analyze efficiency metrics, labor utilization, and operational KPIs; implement corrective actions to maximize productivity.
• Champion quality assurance initiatives, ensuring products meet or exceed customer expectations.
• Enforce a strong safety culture, ensure compliance with company and regulatory standards, and participate on the Safety Committee.
• Own and manage inventory control, ensuring materials and stock levels are maintained in coordination with Materials Management.
• Identify and lead continuous improvement initiatives to reduce waste, improve flow, and streamline operations.
• Use P&L reports and operational dashboards to monitor expenses, labor costs, waste, and factory supplies to meet budgetary targets.
• Provide leadership, coaching, and technical guidance to department supervisors and production teams.

Qualifications:

• 5–10 years of progressive experience in manufacturing and distribution operations, ideally within sheet metal or custom metal fabrication.
• Bachelor’s degree in engineering, Operations Management, Industrial Technology, or a related field preferred, but will consider a strong record of experience and achievement in lieu of degrees.
• Proven track record in leading production teams and driving operational improvements.
• Strong hands-on experience with laser cutting, turret punching, shearing, bending/forming, brake press operations, MIG/TIG welding and mechanical assembly.
• Working knowledge of ERP systems and ability to integrate data into daily decision-making.
• Proficiency in MS Office Suite (Excel, Word, Outlook, Teams).
• Strong mechanical aptitude and the ability to troubleshoot fabrication equipment.
• Excellent communication, leadership, and problem-solving skills.
• Flexibility to work overtime and occasional weekends as required.
• Familiarity with logistics and distribution is a plus.

What We Offer:

• A positive, team-oriented culture focused on growth and operational excellence.
• Competitive compensation and benefits package, including:
• Medical, Dental, and Vision insurance
• Flexible Spending Account (FSA)
• 401(k) with company match
• Life Insurance, AD&D & LTD
• Paid Time Off
• Annual Performance Bonus
• An opportunity to make a direct impact in a growing, established company.

Physical Requirements:

• Ability to stand, walk, and sit for extended periods.
• Regular lifting of up to 50 lbs.
• Frequent stooping, bending, kneeling, and working in a non-temperature-controlled environment.
• Must wear required PPE (eye protection, protective clothing, etc.).

Equal Opportunity Employer

This company prohibits discrimination and harassment of any type and is proud to be an Equal Opportunity Employer.

Logistics Planner Specialist II

Location(s): West Point, PA; Rahway, NJ

Work Environment: Hybrid

Job Summary:

The Logistics Planner Specialist II is responsible for driving tasks to completion and mentoring junior staff. This role requires a heightened level of autonomy and strong business acumen. The Logistics Planning Specialist will be responsible for supporting and work cross-functionally with, but not limited to, Clinical Supply Planning, Country Clinical Operations, CMOs/CROs, Distribution, Regulatory, External Operations Management, Operational Expense Management, Trade Operations, and Trade Compliance to support and plan distribution for Clinical Trial Material utilizing approved depot networks. Act as the Logistics Planner and develop distribution plans and execute activities for network preparedness of distribution activities. Communicate with all constituents and be the advocate for the distribution strategy for clinical trials. In addition to typical distribution planning activities, the individual will also be responsible for alignment of the lead-time and routing in SAP, and cost analysis for distribution network selection. Collaborate across functions and contribute to cross-functional initiatives, and, where appropriate, assume leadership of low-to-moderate complexity projects to drive defined outcomes.

Key Responsibilities:

• Drive tasks to completion amidst ambiguity.
• Mentor junior staff and provide guidance on project management.
• Collaborate across functions to achieve business objectives.
• Ownership of SAP-related processes that Logistics Planning is accountable
• Project Contributor, and at times lead, for both internal and cross-functional projects
• Proficient in cGMP
• Ability to function in a team environment and pursue information when it is not readily available.
• Communicate with all constituents and be the advocate for the clinical trial distribution strategy
• Partner with Clinical Supply Planning and Distribution Centers to oversee and implement distribution planning documents for clinical study protocols
• Represent Logistics Planning at internal communication meetings
• Serve as the functional area expert on country shipping and trade compliance, distribution routes, country and global distribution challenges
• Adherence to regulatory, global and site policies and procedures governing operations activities are critical.

Qualifications:

• Bachelor's degree preferred; candidates with relevant experience may be considered.
• 3+ years of experience in a related field; candidates without a degree should have 6+ years of relevant experience.

General Skills:

• Strong communication and proficient project management skills.
• Ability to collaborate across functions and teams.
• Analytical thinking and problem-solving skills.
• Detail-oriented with the ability to prioritize tasks effectively.

Unique Responsibilities:

• Ability to make connections at a higher level within the function.
• Self-motivated with the ability to mentor others.

Metrology Specialist I

On-site in West Point PA

Summary:

• Manage equipment assets at multiple locations
• Gain a working knowledge of laboratory equipment to facilitate with troubleshooting and/or communicate with the vendor/ service engineer to identify resolutions
• Participate in computer system validation activities associated with new or upgraded equipment or software packages.
• Originate and progress Deviations and Change Control records
• Perform and document investigations and assist in developing and implementing CAPA plans
• Contribute to new SOP drafting, implementation, and revisions.
• Represent the laboratory on all aspects of laboratory equipment during audits.
• Ensure compliance with all regulatory requirements (cGMP), internal policies and procedures.
• Customer focused mindset with the ability to communicate adequately (verbally/writing) to all levels within the organization.
• Willingness and ability to quickly upskill in Merck Facilities/Instrument support programs SAP, ProCal, BAS, LAMP, Electronic Validation, and other document and/or asset repositories
• Initiate, process and track work orders to facilitate timely repairs, modifications and moves of laboratory equipment.

Calibration Focus:

• Prepare, review, and approve archive instrument/equipment documentation such as master equipment lists, user access reviews, Instrument Installation & operational qualification documentation, and calibration documentation.
• Coordinate service activities across a variety of vendors and service engineers while building and maintaining strong working relationships.
• Collaborate with metrology staff across multiple testing labs and sites for process improvement, cross-training and cross-site support.

Support the purchase, installation, and equipment qualification of new laboratory equipment.

*** There will be training opportunities to support Validation*** Validation activities are included below

• Support primarily the qualification/validation of computerized analytical systems as per current guidelines.
• Partner with the business unit in the laboratories, various quality support oversight, IT technical support, and various software and instrument vendors/manufacturers.
• Perform any required change control during the life cycle of a computerized system.
• Decommission systems as required as part of the equipment qualification/validation life cycle.
• Manage the capital purchasing and initial installation of computerized analytical systems prior to validation.
• Participate in various data integrity and lab modernization activities as required.
• Will possess direct experience operating analytical instrumentation within a pharmaceutical or equivalent laboratory (vaccine or large molecule focus).
• Will have the ability to thoroughly review and scrutinize validation requirements through the life cycle of the system.

General Requirements Level 1:

-Bachelor’s degree in biological or chemical science and/or engineering plus

-2-4 years of experience participating in the validation of computerized laboratory systems or instruments (e.g. system Installation and Operational qualification, Performance qualification

-Experience working in a GMP environment and maintaining laboratory equipment.

-Highly organized, strong communication skills.

-Capable of working independently.

-Solutions orientated mindset with the ability to handle multiple high priority tasks at one time.

-Ability to succeed in a dynamic environment; flexibility to respond to changing priorities.

-Awareness to independently prioritize tasks and responsibilities based on actual or perceived level of importance and/or potential impact to the GMP environment.

JOB OVERVIEW:

The Validation Scientist position encompasses all areas of Technical Services with primary focus on technology transfer, scale-up, process optimization, process/packaging validation, commercial production technical support as well as equipment qualification and cleaning validation support.

KEY ROLES/RESPONSIBILITIES:

• Lead and execute projects such as technology transfer, scale-up, process optimization process/packaging validation as well as equipment qualification and cleaning validation support to meet critical project deadlines.
• Provide technical support in the investigation of manufacturing incidents and major deviations. Assure thoroughness of investigation and documentation as well as implementation of preventive/corrective actions as necessary.
• Conduct commercial production technical support activities such as qualification of alternate suppliers of API, excipients and packaging components, equipment change parts, process parameters, yield limits, hold time studies, etc.
• Execute utility and process equipment qualification support activities such as installation, operational and performance qualifications, periodic reviews, investigations, assessments, review change control and non-routine maintenance requests, out of specification calibrations, etc.
• Perform cleaning validation support activities such as execution of cleaning validation and verification studies, hold time studies, investigations, assessments, justifications, maintain cross contamination program, etc.
• Develop and/or execute experimental designs and approaches to resolve technical problems and utilize engineering standards, principles, concepts, equations as well as statistical techniques.
• Prepare and review documents to support projects, such as laboratory notebooks, protocols, reports, assessments, justifications, investigation reports, regulatory submissions, master batch records, change control, etc.
• Complete and document physical sampling and testing such as loss on drying, particle size distribution, bulk density, viscosity, pH, tablet weight, thickness, hardness and friability; sample for analytical and microbiological testing.
• Author and periodically update assigned Standard Operating Procedures (SOPs) for the department.
• Represent Technical Services at project team meetings and provide sound technical advice.
• Coordinate and interface with Operations, Facility Engineering, Quality Control, Quality Assurance and Regulatory Affairs groups to assure successful project execution.
• Directly interact with Piramal Pharma Solutions clients.
• Maintain regulatory compliance within the function and follow site safety, health, and environmental policies and procedures.

EXPERIENCE:

• Minimum of a Bachelor's degree in a scientific discipline (e.g., Chemical Engineering, Pharmaceutics, Pharmacy, Chemistry or equivalent) with a minimum of 3 years experience in Technical Services, Process Engineering, Process Validation, Formulation or related field in the pharmaceutical industry.
• Experience in laboratory and production scale manufacture of solid oral, liquid and semi-solid dosage forms using equipment such as comminuting mills, high-shear granulators, fluid bed dryers, blenders, tablet presses, tablet film coaters, encapsulates, low and high-shear mixing vessels, homogenizers, pumps, packaging, etc.
• Working knowledge of cGMP (Current Good Manufacturing Practices) regulations, SUPAC guidance, and general compliance expectations.
• Working knowledge of investigational techniques, including but not limited to root cause analysis, risk assessment impact evaluation, and technical report writing.
• Must possess research and problem solving abilities and be capable of producing detailed documentation, understand and make generalized and specific conclusions from project data.
• Technical writing experience is required with attention to detail skills essential.
• Must be able to work in a team environment with effective project planning/management, analytical thinking, organization, and execution skills.
• Must have proficiency in the Microsoft Office Suite programs.
• Demonstrated professionalism and excellent communication skills with internal and external personnel are essential.
• Ability to work effectively managing multi projects at a fast pace withcross-functional departments and manage priorities to meet timelines.
• Must be innovative, proactive, resourceful and committed to continuous improvement.
• Working knowledge of cGMP data management systems (EDMS, Trackwise, and/or SAP) is preferred.

WORK ENVIRONMENT:

The position requires the ability to work in ahigh demand office and manufacturing setting with time spent performing "on the floor" activities in laboratory and manufacturing areas. The position may require extended hours including evenings and weekends as well as work hours on 2nd and 3rd shifts depending on project needs.