Engineering Jobs in Pennsylvania

Logistics:

Company: Clopay Corporation

Position: Senior Mechanical Engineer

Location: Mountain Top, PA

• Onsite 5 Days/Week

Salary Range: $90,000-$110,000/year

Duration: Full-Time

Anticipated Start Date: April 2026

Interview Process: 3 Rounds

Company Overview:

CornellCookson, a division of Clopay Corporation, is a leading manufacturer of commercial and grille doors. We pride ourselves on delivering exceptional customer service as well as unsurpassed quality and innovative products. Our employees are the cornerstone of our success and we are looking for dynamic individuals to join our team.

Project Overview:

We are seeking a Sr. Manufacturing Engineer to join our Strategic Manufacturing team to design new processes and improve existing manufacturing cells. Activities range from manufacturing cell conceptual design, tool prototyping, sourcing, testing, manufacturing integration, and engineering change order execution. Come join us and get your process design, automation, and improvement juices flowing!

Responsibilities will include process ownership, capital investments, manufacturing cell setup, design for manufacturability, fixturing design, process development and continuous improvement projects.

Responsibilities/Principal Duties:

• Identify and execute new equipment Capital Expenditure projects
• Identify methods of improving the productivity of existing systems, taking into consideration the use of the latest technology
• Develop and design new manufacturing process cells for manufacturing
• Use Autodesk Inventor to design and layout part and assembly drawings using standard drafting practices
• Oversee the installation, startup and qualification of equipment
• Develop manufacturing process capabilities and standards
• Conduct economic analyses on new methods/equipment
• Recommend plans for facility layout as well as process flow improvements
• Calculate production costs that include equipment, time and labor
• Ensure organization is ready to support and manufacture new products
• Coordinate with IT and configurator groups to modify ERP system and work order routers
• Develop and modify work instructions
• Maintain positive customer, vendor, and coworker relationships
• Be dedicated, self-initiating, and passionate about mechanical design, implementation and improvement
• Contribute to new product ideas and designs, focused on Design for Manufacturability
• Independently manage time and prioritize tasks
• Interact with New Product Development, Design Engineering, and Continuous Improvement teams
• Oversee and/or perform assembly and testing of engineering prototypes
• Validate designs for conformance to various structural and life safety codes and standards as required (ASCE, IBC, UL, etc.) through engineering evaluations and calculations
• Work with Machinists and Fabricators to develop prototypes
• Present and communicate designs/ideas clearly to associates ranging from shop associates to executives

Required Qualifications:

• Bachelor’s Degree in Mechanical Engineering, Automation Engineering, or similar
• A minimum 7-years of full-time experience, 10-years preferred
• Proficient mechanical design skills with 3D Solid Modeling using Inventor or SolidWorks
• Knowledge and application of AutoCAD
• Excellent communication skills and ability to work within and lead a cross functional team
• Proficiency with hand tools and basic power tools
• Ability to convey complex, three-dimensional mechanical system to technical and non-technical personnel.

Preferred Requirements:

• 7+ years of experience in a manufacturing engineering role
• PE/FE certificate
• Proven track record in design and specification of sheet metal, structural steel, tooling and fixtures
• Experience with project management of smaller projects through completion involving multidisciplinary teams
• Experience in the door, access control, actuation, or building products industries
• Technical experience with design and project development, product improvements and optimization
• Experience with welding, milling, laser, casting and other modern methods of metal fabrication

We offer a competitive salary and a very comprehensive benefits package, including 401K, paid holidays, sick, and vacation time.

Equal Opportunity Employer, providing a drug-free work environment.

Founded over 35 years ago, First Quality is a family-owned company that has grown from a small business in McElhattan, Pennsylvania into a group of companies, employing over 5,000 team members, while maintaining our family values and entrepreneurial spirit. With corporate offices in New York and Pennsylvania and 8 manufacturing campuses across the U.S. and Canada, the companies within the First Quality group produce high-quality personal care and household products for large retailers and healthcare organizations. Our personal care and household product portfolio includes baby diapers, wipes, feminine pads, paper towels, bath tissue, adult incontinence products, laundry detergents, fabric finishers, and dishwash solutions. In addition, we manufacture certain raw materials and components used in the manufacturing of these products, including flexible print and packaging solutions.

Guided by our values of humility, unity, and integrity, we leverage advanced technology and innovation to drive growth and create new opportunities. At First Quality, you’ll find a collaborative environment focused on continuous learning, professional development, and our mission to Make Things Better®.

We are seeking a Quality Assurance Manager for our First Quality Retail Services facilitylocated in Lewistown, PA.

This position will be responsible for the creation, implementation and monitoring of all corporate & site Quality practices within their site of operation. Leading a team of quality professionals and driving a culture of continual improvement. Play a pivotal role and work collaboratively within the site management team, and drive quality engagement through all levels of the organization.

Primary responsibilities include:

• Provide leadership and planning to develop, implement and maintain quality systems to ensure compliance to regulatory, industry, and customer standards.
• Serves as the Management Representative for all site compliance and quality systems
• Supervises the activities of assigned staff and monitor the activities of QA/QC personnel within the QA Department.
• Assure that all resources utilized for the quality functions are procured, maintained, and perpetuated in a cost effective and timely manner within the goals of the strategic business plan.
• Take the leadership role in maintaining/changing the quality culture of the company – serve as the visible model of Quality. Educate team members in the quality philosophy and practices, including improvement strategies.
• Represents the company to vendors, customers, and appropriate regulatory officials in matters related to quality.
• Administers the quality audit program.
• Provides training to team members, as required, for implementing quality initiatives.
• Work with cross-functional teams to prioritize key site projects and determine appropriate resources and timing; integrate lean six sigma activities with quality system activities such as Corrective and Preventive Action (CAPA) and Quality Improvements to assure effectiveness and compliance to customer and regulatory requirements.
• Develops annual quality plans and recommendations for continual improvement in conjunction with the Quality Leader and Operations Manager
• Determines methods and implements plans for professional development of personnel within the QA Department.
• Proposes budgets and monitors budget activity for the QA Department.
• Provides statistical analysis for evaluation of processes, and issue KPI reports to site leadership and divisional leaders at determined frequencies.
• Conducts lab tours and explains quality system to visitors.
• Understands competitive product features in comparison to products.
• Completes required reports and summaries for regulatory & industry agencies.
• Assists and substitutes for the Divisional Quality Leader, as needed.
• Observes all safety rules and always uses the proper safety equipment.
• Performs other duties as necessary when directed to do so.
• Follows necessary GMP, FDA, and ISO regulations.
• Manage master validation plan.
• Implement, monitor and review online Quality systems, including vision QMS Software, and SPC systems.

The ideal candidate should possess the following:

• Bachelor’s degree in an Engineering, Technology, Mathematics, Business, or Science discipline.
• Three years minimum experience as a Quality Manager, Technical Manager, or QC Supervisor in a manufacturing environment (preferably FDA-regulated environment).
• Six sigma Green Belt certified, preferred.
• Supervisory experience.
• Auditing experience in GMP and/or ISO systems.
• ASQ Certification or equivalent training (CQE, CQA, CQT, or CQM).
• Advanced skills in oral and written communications.
• Standard skills in technical, business, and managerial fields.
• Standard skills in statistics, procedure implementation, and quality auditing.
• Competent in interactions with executive management, vendors, and customers.

What We Offer You

We believe that by continuously improving the quality of our benefits, we can help to raise the quality of life for our team members and their families. At First Quality you will receive:

• Competitive base salary and bonus opportunities
• Paid time off (three-week minimum)
• Medical, dental and vision starting day one
• 401(k) with employer match
• Paid parental leave
• Child and family care assistance (dependent care FSA with employer match up to $2500)
• Bundle of joy benefit (year's worth of free diapers to all team members with a new baby)
• Tuition assistance
• Wellness program with savings of up to $4,000 per year on insurance premiums
• ...and more!

First Quality is committed to protecting information under the care of First Quality Enterprises commensurate with leading industry standards and applicable regulations. As such, First Quality provides at least annual training regarding data privacy and security to employees who, as a result of their role specifications, may come in to contact with sensitive data.

First Quality is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identification, or protected Veteran status.

For immediate consideration, please go to the Careers section at complete our online application.

Join the MEPPI Team!

Mitsubishi Electric Power Products, Inc. (MEPPI) is seeking a Quality Assurance Engineer II - Manufacturing to plan, direct and support activities to assess and provide for root cause analysis and corrective action implementation for Transportation Systems Division (TSD) quality problems. Implement and maintain quality assurance programs and lead efforts with internal audits.

This position will report to the TSD Quality Assurance Section Manager and is an onsite position in Freedom, PA.

What You’ll Do:

• Participate in and/or lead supplier validation audits using product quality planning tools.
• Collaborate with suppliers to investigate quality problems, identify root causes of problems, develop correction action plans and implement improvements. Verify corrective actions are implemented and maintained.
• Serve as a quality assurance liaison to Japan. Learn and implement applicable Japanese techniques for quality assurance improvements.
• Participate in the development of new products or modifications of existing products to meet customer requirements.
• Participate in and/or lead internal audits. Work with all departments to help close audit findings in an effective and timely manner.
• Coordinate continued evaluation of procedures and documentation throughout TSD. Verify for completeness, accuracy and lack of redundancy.
• Facilitate in-house quality assurance and manufacturing improvement programs throughout TSD.
• Assure quality records are generated, retained, stored, protected and disposed of according to TSD and Company policies.

What You’ll Bring:

• Bachelor’s Degree in Engineering or related technical field with 3-5 years of experience in quality control and/or assurance function, or equivalent education and experience.
• Advanced knowledge of QA and manufacturing improvement practices such as Lean Six Sigma and Black Belt and an understanding of the underlying philosophy.
• Advanced knowledge of quality techniques such as Statistical Process Control, Deming Methods, 5-Why, 8DS, etc.
• Advanced interpersonal communication and presentation skills required to communicate with customers, vendors and employees.
• Advanced analytical and problem-solving skills.
• Advanced computer skills with emphasis on MS Office products and MRP/ERP systems.

What’s in It for You:

Comprehensive Health Coverage:

• MEPPI pays up to 90% of the cost for medical, dental, and vision plans.

Retirement Plans:

• 401(k) match of up to 4%.

Generous Paid Time Off:

• Earn vacation after just 90 days, plus enjoy 12 paid holidays annually.

Career Growth:

• Access to professional development programs and educational assistance.

Employee Perks:

• On-site fitness center (Warrendale, PA), wellness program, profit sharing, and employee discounts.

Why MEPPI:

As a proud U.S. affiliate of Mitsubishi Electric, MEPPI powers critical infrastructure and rail transportation solutions across North America. We value collaboration, innovation, and people—because we know that our greatest asset is our team. Join us and help shape a future where talent and technology thrive

Equal Opportunity Employer:

MEPPI is committed to diversity and inclusion in the workplace. We welcome applicants from all backgrounds and ensure fair consideration for every candidate.

Notice to Agencies and Search Firms:

We do not accept unsolicited resumes from agencies. Submissions without signed agreements become the property of MEPPI, and no fees will be paid.

Applicants are considered for all positions without regard to race, color, religion, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, marital status, national origin, ancestry, age, physical or mental disability or (as defined by applicable law) medical condition or genetic information, military or veteran status or any other legally protected status.

Notice to Agency and Search Firm Representatives: Mitsubishi Electric Power Products, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Mitsubishi Electric Power Products, Inc. employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Mitsubishi Electric Power Products, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

Core Requirements:

• Bachelor’s degree in Engineering or Manufacturing Technology.
• 8+ years of senior leadership experience in aerospace or automotive precision manufacturing.
• Proven success launching facilities or leading major manufacturing expansions.

Preferred Requirements:

• MBA degree
• Experience implementing MES, ERP, IIoT, and digital manufacturing platforms.

The successful candidate will be responsible for building a high-performing technical organization, deploying advanced manufacturing systems, and establishing a benchmark facility in precision manufacturing through innovation, digitalization, and continuous improvement. They will also partner closely with senior leadership to define and execute a future-ready automation and smart manufacturing strategy.

CiresiMorek is a collective of seasoned professionals, each bringing a wealth of experience and a personal touch to all our engagements. With over 3,500 searches and around 1,600 Operations placements, we are more than just headhunters; we are industry insiders, advisors, and diligent architects behind every successful placement.

Responsibilities:

• Define and execute the site’s automation and technology strategy in alignment with business objectives and long-term growth plans.
• Lead the design, build-out, and commissioning of manufacturing equipment, automation systems, and digital infrastructure for a greenfield operation.
• Integrate CNC, forming, robotics, material handling, and PLC-based systems with MES/ERP platforms to enable smart manufacturing.
• Establish lean, data-driven manufacturing processes, standard work, and control plans to support safety, quality, and efficiency.
• Drive continuous improvement and innovation across automation, digital manufacturing, and analytics capabilities.

Confidentiality is guaranteed. Applications require a resume/CV with contact information.

Learn more about us at CiresiMorek.

Addison Group is working with a prominent manufacturing company in search for an entry level engineer with a Mechanical Engineering degree. This is onsite 5 days a week in Irwin PA, please apply to be considered.

The Engineering Coordinator provides both administrative and technical support to the Engineering Department, ensuring efficient project execution, accurate document control, and seamless coordination across functional teams including Project Management, Sourcing, Assembly, Contract Shop, Applications, Proposal Engineering, and Service.

This role plays a critical part in maintaining accurate engineering data, drawings, bills of materials (BOMs), and change orders, ensuring that information is current and effectively communicated throughout the organization.

Key Responsibilities

Project Coordination & Tracking

• Assist engineers with planning, scheduling, and tracking engineering projects
• Monitor timelines and deliverables to support on-time project completion

Documentation & Data Management

• Maintain and update engineering documentation, including drawings, BOMs, specifications, and technical files
• Process engineering change requests and change orders through established workflows
• Ensure document control processes comply with ISO standards
• Update drawings with redlines
• Generate part numbers and manage revisions

Cross-Functional Communication

• Track and manage technical support requests from Assembly, Sourcing, Service, Applications, Contract Shop, and Proposal Engineering
• Facilitate clear communication between engineering and other departments

Administrative & Systems Support

• Assist in preparing engineering KPI reports
• Capture meeting minutes and track follow-up actions
• Prepare status reports and progress updates for management

Benefits: Medical, dental, vision, 401(k)

About Us

We shape the connected world!

HMS Networks makes the World more connected, productive and sustainable. HMS industrial communication products enable millions of machines such as robots, drives and air-conditioners to get connected to software and systems – A necessity to meet the future demands for energy efficiency and sustainability.

Position Summary

Reporting to the Manufacturing Engineering Manager, this role is required to perform preventative maintenance, continuous improvement initiatives, programming and repair duties for the company owned equipment such as SMT equipment, THM/PTH equipment, test fixtures, solder fixtures, fume extracts, and other equipment in our PCBA manufacturing departments. The role will also maintain, repair, program and assist in the installation of new equipment. It will also be the responsibility of this role to keep the work area and equipment in a clean and orderly condition.

Essential Job Functions

• Identify and resolve PCBA manufacturing issues to ensure production efficiency and quality.
• Maintain and repair equipment, tools, and machinery as needed.
• Document and maintain weekly, monthly, and annual preventative maintenance requirements.
• Works independently but supports other team members as needed or required to complete tasks.
• Knowledge of fabricating parts from aluminum, steel, brass, and other metals or from plastic with ability to solder wires and components.

Minimum Requirements

• 1-3 years’ experience with SMT or THM/PTH equipment maintenance, repair and programming.
• Experience working independently with little direction.
• Must have basic communication skills to comprehend manuals, instructions, and correspondence.
• Basic knowledge of multiplication, division, algebra, measurement, and distance.
• Required to keep equipment and supplies organized in addition to communicating cross functionally to ensure proper supplies are stocked at all times.

Working Conditions

• Regularly required to stand, walk, stoop, talk, and hear.
• Use of hands to touch, feel, or handle and reach with hands and arms.
• Regularly required to lift and or move up to 50 pounds and on occasion up to 100 pounds.
• Visual acuity required for close work, color differentiation, depth perception, and to adjust focus.

HMS Networks provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, HMS Networks complies with applicable state 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.

We are a U.S.-based, privately held, mid-sized company operating in the aftermarket industrial sector. With a global footprint, we provide engineering services and repair solutions for high efficiency pumping equipment across key industries including oil and gas, steel, nuclear, and pulp and paper. With our corporate headquarters in Chicago, IL, our company prides itself on technical expertise, customer service, and strategic growth across international markets.

We are offering a home-based remotely based sales opportunity for an Account Manager position.

This person will be responsible for the identification, development and implementation of sales strategies and customer solutions in a defined territory and specific customer base in the Refinery, Power Plants, and Oil and Gas markets located in and along the territory within:

Territory – Western Pennsylvania, Western New York and West Virginia.

Sales responsibilities will be for aftermarket pump repairs plus parts, reliability services, sensors and field service within your assigned region. You will be conducting business development activities, cultivating customer relationships, identifying opportunities for growth, closing new business and ensuring business objectives/strategies are met within a company with a supportive culture, including our technical and sales resources to help you be successful in your role. You will have many resources available to you including a 5,000 HSP test lab, strong engineering support, high quality marketing tools, including media, brochures, case studies and training resources. You will also have access to experienced shop personnel who believe in providing our customers with a high-quality value solution.

Essential Job Accountabilities:

• Maintain current relationships with key accounts and prospect new customers continuously.
• Execute sales calls and identify new opportunities with both existing customers and new accounts in assigned geographical area.
• Grow sales within geographic territory in alignment with assigned revenue and new account development targets.
• Report sales activities in Salesforce CRM Software.
• Provides continuous improvement in sales coverage and effectiveness developing key areas and markets to include market share information and action plans.
• Provide technical support to customers and interfaces with engineering to assure best hydraulic fit and optimal equipment efficiency.
• Develop sales forecasts for the region.
• Define and assist management in developing solution-based proposals that will demonstrate product value to new and existing customers while optimizing revenue and profit of sale.
• Participate in weekly production /sales meeting to inform management of current and future activity.
• Work collaboratively with operations to identify and maximize margins and business profitability.
• Attend trade shows and industry events that impact business and build customer rapport.
• Effectively promote all of Hydro's value-added products and services, utilizing a "Total Solutions" sales strategy.
• Continuously build the Hydro brand, both in person and in social media presence.
• Manage travel and entertainment expenses in accordance with budgets and corporate policies.
• Travel up to 75% for in-person meetings at customer facilities within assigned geographic territory.

Job Requirements:

To perform the job successfully, an individual should demonstrate the following competencies:

• Minimum education requirements include technical degree (mechanical engineering preferred) or equivalent combination of experience and education.
• 5 years prior experience as a Sales Engineer, Field Service Engineer or mechanical engineer or similar.
• Experience and knowledge of aftermarket service and solutions related to rotating equipment primarily with pumps.
• Superior technical skills with an in-depth knowledge of various types of pumps and pumping systems and a demonstrated knowledge of historical pump information along with a solid understanding of theoretical pump technologies.
• Strong business acumen and understanding of profitability in a service business environment
• Possess the ability to define problems, collect data and establish facts and valid conclusions.
• Have outstanding Customer Service skills and abilities in conjunction with a positive attitude and demeanor in sales settings and at site facilities.
• Proficient computer skills including Microsoft suite applications, with above average Excel and CRM experience.
• Must possess a high attention to detail, have exceptional time management skills.
• Have strong analytical and problem solving skills with an understanding of the root cause failure analysis process.
• Ability to facilitate solutions in a fast paced, complex technology, and business environment.
• Ability to work independently and be self-motivated while also being able to work effectively in a team environment.

Work Environment:

• Work is generally performed in a office environment and there will be instances that require activities in an industrial setting.
• Individual is required to comply with safety standards and regulations and use proper PPE.

We offer a full benefits package with a matching 401k and an entrepreneurial opportunity in a privately held organization.

Description:

The Director of Operations will oversee all production and facility operations at ALIGN Precision Philadelphia, ensuring seamless execution across precision machining, assembly, and cleanroom environments. This role will serve as the operational hub, coordinating with the Director of Planning & Delivery and Director of Quality to deliver on customer commitments while driving efficiency, safety, and culture. Reporting directly to the Site General Manager, the Director of Operations will translate strategic goals into daily execution and long-term capability building.

Essential Duties and Responsibilities:

Production & Facilities

• Provide leadership to a staff of Production Supervisors and CNC Programmers.
• Lead machining, CNC programming, assembly, and cleanroom operations.
• In cooperation with the Director of Maintenance, oversee facilities management, equipment utilization, and preventive maintenance.
• Ensure Safety, Quality, Delivery, and Cost targets are consistently achieved.
• Develop the operations and capital equipment budget.
• Champion 5S workplace organization.

Scheduling & Capacity Planning

• Develop daily plans and execute production schedules against the master schedule.
• Cooperate with Planning and Delivery through the SIOP process providing inputs into capacity planning and modeling, aligning with the supply chain and customer demand.
• Partner with Planning and Delivery to balance inventory strategies with operational readiness.
• Collaborate with Quality and Engineering to embed process controls and ensure compliance.

Continuous Improvement

• Drive Lean, Six Sigma, and Kaizen initiatives across production areas working closely with Engineering.
• Implement systems for performance metrics, accountability, and operational transparency.
• Champion waste reduction, cycle time improvement, and productivity gains.

Culture & Leadership

• Build a culture of engagement, accountability, and innovation.
• Mentor supervisors and team leads, fostering psychological safety and high performance.
• Facilitate employee engagements and cross-functional collaboration to surface systemic themes.

Cross-Functional Alignment

• Act as the connective agent between Planning and Delivery, Quality, Engineering, Program Management and Business Development.
• Support business development by ensuring operational readiness of our expanded cleanroom and CNC automation for new verticals.
• Collaborate with leadership to embed strategic operating systems across the enterprise.

Qualifications:

• Bachelor’s degree in Engineering, Operations Management, or related field.
• 10+ years of leadership experience in precision machining, semi-conductor, aerospace, medical devices, or advanced manufacturing.
• Proven success in production leadership, scheduling, and facilities management.
• Strong background in Lean, Six Sigma, and operational excellence.
• Excellent leadership, communication, and team-building skills.
• Ability to balance strategic vision with hands-on execution.

Other Skills Required:

• Communications - Exhibits good listening and comprehension.

• Business Acumen - Understands business implications of decisions; displays orientation to profitability; demonstrates knowledge of market and competition. Aligns work with strategic goals.

Language Skills:

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Mathematical Skills:

Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Reasoning Ability:

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Computer Skills:

To perform this job successfully, an individual should have an understanding of Microsoft Office Software- especially knowledge of Microsoft Word and Microsoft Excel.

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 will be in the office and shop and required to sit, stand and walk.

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.

ADDITIONAL NOTES:

ALIGN Precision is an Equal Opportunity Employee and wholeheartedly supports diversity in the workplace as a basic premise for business success. All employees of ALIGN Precision are employed on an at-will basis.

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments.

A review of this position has excluded the marginal functions of the position that are incidental to the performance of fundamental job duties. All duties and responsibilities are essential job functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbent(s) will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

Summary:

The Head of Production (Sterile Injectables) is responsible for providing strategic and operational leadership for all aspects of sterile manufacturing operations. This role ensures compliance with cGMP regulations, drives operational excellence, and leads high-performing teams to achieve manufacturing objectives in a regulated environment.

Responsibilities:

• Direct and oversee all sterile manufacturing operations, including component preparation, formulation, compounding, aseptic filling, visual inspection, and packaging.
• Develop and implement production strategies to achieve manufacturing goals, supply commitments, and performance targets.
• Ensure all manufacturing activities adhere to cGMP regulations, internal quality systems, and regulatory requirements for sterile drug products.
• Maintain a continuous state of audit readiness and support regulatory inspections, internal audits, and customer audits.
• Lead and manage investigations, deviations, CAPAs, and change control processes impacting production operations.
• Establish, monitor, and report on key performance indicators (KPIs) related to safety, quality, delivery, and productivity to drive accountability and improvement.
• Champion operational excellence initiatives to enhance manufacturing efficiency, reduce waste, and improve process reliability.
• Build, develop, and lead high-performing production teams, fostering a culture of compliance, safety, and continuous improvement.

Qualifications:

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or a related scientific field required; Master’s degree preferred.
• 8–15 years of progressive experience in pharmaceutical manufacturing operations within a regulated cGMP environment.
• 5–12 years of leadership experience in sterile or aseptic pharmaceutical manufacturing settings.
• Proven experience overseeing operations such as formulation, compounding, aseptic filling, visual inspection, and/or packaging of pharmaceuticals.
• Strong knowledge of FDA cGMP regulations and regulatory expectations for sterile drug product manufacturing.
• Experience supporting regulatory inspections and maintaining audit-ready operations.
• Demonstrated ability to lead investigations, manage deviations, CAPAs, and change control activities.
• Proven leadership skills with experience developing and managing production teams in regulated environments.

We have two positions

Position 1

LinkedIn Pitch – QC Lead Investigator / Event Owner (Lab Equipment) | Philadelphia, PA

Join the Quality Control organization at Spark in Philadelphia as a QC Lead Investigator focused on laboratory equipment investigations and quality events. This contract role is ideal for someone experienced in QC/QA within regulated environments who enjoys digging into root cause, driving CAPAs, and improving lab systems.

You’ll lead equipment‑related investigations, manage deviations and change controls, support regulatory inspections, and serve as a system administrator for key QC lab platforms (Empower, Qx Manager, LabX, SoftMax, qPCR, etc.). Strong documentation, cross‑functional collaboration, and technical writing skills are essential.

Candidates should bring a Bachelor’s in a scientific or engineering field, hands‑on experience in GMP/regulated operations, and familiarity with root‑cause tools (5 Whys, Fishbone, FMEA). Experience with Veeva Vault QMS is a plus. This role is on‑site ~80% with standard business hours and some flexibility.

If you’re analytical, detail‑driven, and ready to support high‑visibility QC operations in a fast‑paced biotech environment, this is a strong opportunity to make an impact.

Position 2

LinkedIn Pitch – QC Lead Investigator / Event Owner | Philadelphia, PA (Onsite)

Spark’s Quality Control organization in Philadelphia is looking for a QC Lead Investigator/Event Owner to drive laboratory equipment investigations and quality events in a fast‑paced, highly regulated biotech environment. This contract role is ideal for someone who thrives on root‑cause analysis, CAPA execution, and cross‑functional problem‑solving.

In this position, you’ll lead equipment‑related investigations, manage deviations and change controls, support regulatory inspections, and partner closely with QC, QA, Lab Systems, and IT teams. You’ll also perform system admin tasks for key QC lab platforms and ensure documentation meets cGMP and global quality standards.

Candidates should bring a Bachelor’s in a scientific or engineering field, hands‑on QC/QA experience in regulated manufacturing, and familiarity with tools like Empower, Qx Manager, LabX, SoftMax, or qPCR systems. Strong technical writing, analytical thinking, and root‑cause methodologies (5 Whys, Fishbone, FMEA) are essential. Experience with Veeva Vault QMS is a plus.

This is an onsite role (~80%) with standard business hours and some flexibility. If you’re detail‑driven, collaborative, and ready to support high‑visibility investigations that directly impact product quality and compliance, this is a strong opportunity to step into a key role within QC.