Engineering Jobs in Pa Remote

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.

Supply Chain & Project Coordinator- US Healthcare BU

Key Responsibilities

Procurement

• Issue purchase orders for materials and components based on production requirements and Bills of Materials (BOMs).
• Obtain supplier quotations and support vendor selection based on cost, quality, and delivery performance.
• Track open purchase orders and follow up with suppliers to ensure on-time delivery.
• Maintain purchasing records and transactions within Microsoft Dynamics 365 Business Central.
• Support cost reduction initiatives and supplier performance improvement.

Production Support

• Review material availability for upcoming production jobs.
• Assist with preparation and release of job travelers, work orders, and production documentation.
• Coordinate with warehouse personnel to ensure materials are picked and staged for production.
• Communicate potential material shortages or delivery delays to production teams.
• Work closely with production and warehouse teams on the shop floor to verify material availability and resolve shortages.
• Take ownership of material availability for assigned production orders to ensure manufacturing schedules are not impacted by supply chain issues.

Inventory Control

• Monitor inventory levels and support reorder planning to prevent shortages.
• Maintain accurate inventory transactions within Microsoft Dynamics 365 Business Central.
• Assist with cycle counting and inventory reconciliation.
• Investigate inventory discrepancies and coordinate corrective actions.
• Support efforts to reduce excess or obsolete inventory and improve inventory turnover.

Project Coordination

• Coordinate end to end delivery of small-scale containment equipment, Pass Boxes, Glassware hoods, Ventilated Balance Enclosures.
• Serve as day-day contact for clients providing regular project status updates
• Review and submit documentation, General Arrangements, Factory Acceptance Tests.
• Participate in lessons learned reviews at project close-out and contribute to the knowledge base

Qualifications

Education

Bachelor’s degree in Supply Chain Management, Business, Engineering, Accounting or related field preferred.

Associate degree with relevant experience may be considered.

Experience

1–4 years of experience in purchasing, supply chain, manufacturing, or inventory control preferred.

Skills

• Familiarity with Microsoft Dynamics 365 Business Central or similar ERP systems.
• Proficiency in Microsoft Excel and Microsoft Office tools, Microsoft Project (preferred).
• Understanding of Bills of Materials (BOMs), purchasing processes, and inventory management.
• Strong organizational, communication, and problem-solving skills.
• Ability to manage multiple priorities in a manufacturing environment.

Biomedical Equipment Technician (BMET)

Contract: 3-month contract with likely extension

Location: Philadelphia – Pennsylvania

Travel: Local travel between nearby healthcare facilities required

Key Responsibilities

• Perform advanced troubleshooting, repair, calibration, and preventive maintenance on biomedical equipment, including: Sterilizers | Laboratory analyzers | General patient care devices | Cardiac/pacing equipment
• Support medical device networking initiatives
• Migrate devices onto segmented clinical networks
• Verify connectivity, cybersecurity compliance, and documentation
• Execute technical procedures alongside clinical teams, IT, and vendors
• Coordinate vendor-supported technical projects and implementations
• Provide general operating room support and navigate clinical environments safely
• Travel locally between facilities to support service requests and projects
• Maintain accurate records in asset management systems
• Follow OEM/AEM procedures and regulatory standards
• Operate independently while collaborating with the clinical engineering team

Required Qualifications

• Associate’s or Bachelor’s degree in Biomedical Equipment Technology, Electronics, Applied Science, or equivalent military/technical training
• 3–5+ years of biomedical equipment experience
• Hands-on experience with multiple equipment types (sterilizers, lab, and patient care devices)
• Experience with medical device networking and network segmentation
• Experience coordinating technical work with vendors and stakeholders
• Ability to work independently in fast-paced clinical environments
• Valid driver’s license and reliable transportation

Preferred Qualifications

• AAMI certification (CBET or equivalent)
• Experience supporting large healthcare systems
• Operating room support experience
• Familiarity with clinical applications, medical PCs, and cybersecurity practices

Interview Process: Onsite technical interviews

Start Timeline: Immediate need / expedited hiring process*

About the Company

TCP Analytical, an integrated manufacturer and distributor of consumable products for the life science research and specialty chemical markets is looking for

About the Role

We are looking for a Purchasing Specialist to join our team in Zelienople, PA. The Purchasing Specialist manages the ordering process and is responsible for ensuring timely orders and deliveries of materials and services to ensure that operational requirements are met. The Purchasing Specialist is responsible for building vendor relationships to secure the best value for the company.

Responsibilities

• Review and analyze purchase order requisitions for accuracy and completeness.
• Place purchase orders for materials, equipment, services, and supplies to ensure conformance with purchasing policies and procedures.
• Select vendors and research products to insure practicality, cost effectiveness, and supply availability.
• Use judgment to consolidate orders to improve freight costs.
• Evaluate requisition and purchase order process, propose process improvements.
• Follow up with vendors, monitor due dates for performance, and track performance over time.
• Implement cost control and cost reduction improvements.
• Prepare, issue, and track pricing requests and requests for proposal (RFP).
• Investigate and develop sources of supply and resolve vendor-related issues.
• Work with Quality Engineer to maintain appropriate vendor quality documents and reports.
• Advise operating departments of potential problems meeting quality and delivery dates.
• Coordinate functionality and roles across business units to optimize performance of entire organization.
• Perform backup support to customer service, accounts payable, and/or accounts receivable.
• Initiate suggested changes and improvements to the quality policy and procedure manuals through immediate supervisor.
• Collaborate with all departments to ensure customer satisfaction through timely and accurate delivery of product.
• Perform all assignments in a safe and cautious manner.
• Engage in interdepartmental problem solving, including instruction and assistance when requested or appropriate for the efficient operation of LabChem.
• Participate and cooperate in all training efforts as requested by employer.
• Accept and perform satisfactorily all reasonable assignments as requested.

Qualifications

• High school diploma required, but Associates Degree (two years) preferred.
• Some science courses, particularly an introductory chemistry course, a plus.
• One year experience preferred, with experience at a scientific, engineering or industrial manufacturer a plus.

Required Skills

• Strong analytical skills.
• Excellent communication and interpersonal skills.
• Ability to work collaboratively across departments.
• Proficient in Microsoft Office Suite.

Preferred Skills

• Experience with procurement software.
• Knowledge of supply chain management.

Equal Opportunity Statement

TCP Analytical is committed to diversity and inclusivity in the workplace. We encourage applications from all qualified individuals.