BioSpectra jobs

Join our team at BioSpectra, Inc., where we lead the way in delivering high-purity ingredients to the top 25 pharmaceutical companies globally. We are dedicated to maintaining the highest standards of excellence in the industry. BioSpectra, Inc. is a privately held, family-oriented organization and a U.S. based manufacturer of GMP pharmaceutical-grade ingredients, including API's, excipients, GMP process chemicals, and bulk GMP buffers and solutions. BioSpectra, Inc. currently has facilities located in Bangor, Wind Gap, Stroudsburg, PA and Scarborough, Canada. Job Summary: This position is responsible for ensuring that equipment, systems, and processes are qualified and validated in accordance with regulatory requirements and BioSpectra's standards. This includes developing, executing, and reporting on equipment, instrumentation, and control system qualifications and re-qualifications Essential Job Duties & Responsibilities: Create Qualification Protocols (IQ, OQ, PQ) for equipment, systems, and processes. Research & upload all support documentation into BioSpectra's document management system as required. Complete Risk Assessments for all qualifications by utilizing Equipment and Process FMEAs (Failure mode and effects analysis). Document the execution of Qualifications and monitors the execution of qualification protocols to ensure successful completion of documentation and compliance with established procedures. Ensure the execution of qualification protocols are completed in a timely manner and within Manufacturing's timeframes. Train personnel executing qualification protocols to understand instructions, accurate documentation practices and ensure compliance to established procedures. Create standard operating procedures for new or current equipment as necessary. Develop and execute temperature and humidity mapping studies within controlled storage areas and report on the execution. Evaluate the impact of any process and/or equipment changes to determine if qualifications and/or re-qualification of process equipment or process measuring tools is required. Work closely with multiple divisions to coordinate qualification efforts and resolve any potential issues through BioSpectra's change control program or CAPA program Review and approve external manufacturer qualification documentation to ensure it aligns with BioSpectra standards, and execute potential factory acceptance testing (FAT) or site acceptance testing (SAT) Assist in preparing for internal and external audits, ensuring all qualification documentation is readily available and in compliance Maintain an accurate database of completed equipment and system qualifications, and equipment qualification status to ensure continued process verification and monitoring of all current and pending qualified systems. Apply the appropriate qualification status in key areas to ensure the qualification status of equipment or systems in communicated to key personnel. Provide timelines for the qualification of equipment, processes or systems. Perform re-qualification of manufacturing equipment and systems in accordance with the current Equipment Qualification Master Plan and associated guidance documents to demonstrate that the equipment performs as intended throughout specified operating and performance ranges. Ensure all critical measuring tools are calibrated as required before the execution of a qualification protocol and files the associated documentation as needed. Identify and implement process improvements to enhance efficiency and effectiveness of the qualification process. Qualifications: Education/Certifications: Bachelor's degree in Science, Engineering or other related discipline, or commensurate experience in chemical, or pharmaceutical manufacturing, ideally with a cGMP manufacturer. Experience: Minimum of one year of equipment qualifications experience at GMP manufacturer. Advanced knowledge of cGMP requirements and practices and experience in an FDA registered facility. Effective working knowledge of performing and understanding qualifications for instrumentation and control systems equipment. Special Skills & Competencies: Must have accomplished analytical, oral communication and technical writing abilities and be able to read, understand and communicate in English. Must be able to understand, analyze and interpret the BioSpectra quality system and related documents. Must be able to logically assess situations, manage multiple complex activities, and make competent, timely decisions amidst changing priorities. Must have advanced knowledge and capability to understand mechanical systems, processes and equipment. Ideally, will have advanced knowledge of instrumentation and control systems equipment. Ability to work at an advanced level with Microsoft Word, Excel, and other applicable software systems as necessary.

BioSpectra, Inc. is a privately held, family-oriented organization and a U.S. based manufacturer of GMP pharmaceutical-grade ingredients, including API's, excipients, GMP process chemicals, and bulk GMP buffers and solutions. BioSpectra, Inc. currently has facilities located in Bangor, Wind Gap, Stroudsburg, PA and Scarborough, Canada. Position Summary: A Security Technician I is responsible for overseeing and maintaining a safe and secure environment for BioSpectra's personnel, property, and assets. The security officer may also manage and/or implement security protocols related to the storage of confidential information and documents. Overnight shift, varying schedule. Major Roles and Responsibilities: • Greets visitors, contractors and registers each at facility entrance in accordance with Building Access and Security SOP. Contacts proper personnel to escort them inside the facility. • 24/7 CCTV surveillance and alarm system monitoring. Saves incident surveillance for future review. • Monitor television and Internet resources, within the guidelines of the BioSpectra Information Services Usage Agreement, for impending weather and traffic conditions. • Run daily test to ensuring all CCTV(s) are functional; report technical malfunctions • Log daily activities, incidents and alarm activities into the pass-down log • Receives vendors and delivery vehicles. Directs vehicles to appropriate dock or parking location in accordance with communication from Supply Chain staff. • Verifies shipments entering and exiting the facility grounds are authorized to do so and are secured • Escorts and supports pest control service • Answers, and transfers, internal and external phone calls in accordance with BioSpectra policy • Maintains clean workspaces • Prevents loss and damage by ensuring trespassers and/or risks are mitigated • Completes security incident reports in a timely manner • Completes debris, ice and snow removal to prevent risk to traffic • Maintains employee roster for entering and exiting applicable facility for emergency responses activities. • Secures premises and personnel by patrolling property, building and facility access points • Dispatch Security personnel to all alarm notifications to investigate alarms. • Ensures swift and effective communication of any emergency on site to applicable leadership or emergency responders • Performs escorting responsibilities for visitors or contractors entering the facility, when applicable • Assists with medical, fire and security emergencies, calling and/or coordinating with emergency services and local authorities • Maintain active communications and transfers through phone and radio to security officers. • Receives regulatory agents and communicates their arrival in accordance with BioSpectra procedures • Completes AED, fire extinguishers, spill kits, eye wash, and first aid stations inspections • Assists Human Resources with sensitive events. • Staying up-to-date with changes to security regulations and industry best practices, and making recommendations for continuous improvement. • Performs other related duties as assigned. Qualifications: • High school diploma or equivalent; previous law enforcement or military background preferred. • Experience on a security team with CCTV usage or a similar role in a corporate or industrial setting. • Knowledge of security protocols and emergency response procedures. • Excellent leadership and communication skills. • Ability to handle high-pressure situations calmly andefficiently. • Good analytical and problem-solving skills. • Strong attention to detail. • Physical fitness and the ability to stand or walk for extended periods. • Excellent written and verbal communication skills. • Ability to work with confidential and classified information. • Proficient with Microsoft Office Suite or related software.

The Logistics Coordinator is responsible for the processing and realization of complicated Bio Pharmaceutical shipments (Realization, and Fulfillment). The Logistics Coordinator plays a critical role in ensuring the accurate, timely, and compliant movement of goods across domestic and international channels. This position requires a detail-oriented professional with strong communication and analytical skills who can collaborate effectively across departments and with external partners. Success in this role depends on the ability to build strong relationships, proactively solve problems, and continuously improve logistics processes to support customer satisfaction and operational excellence. Major Roles & Responsibilities: 1. Commercial & Cross-Functional Communication Serve as the primary logistics liaison for commercial teams, demonstrating strong interpersonal and communication skills. Ensure timely, accurate, and professional communication with internal teams(QA, QC, Purchasing, Commercial, Manufacturing) and external clients to support seamless order fulfillment. 2. Data Analysis & Quote Preparation Collect and analyze key shipment data (e.g., freight rates, dimensions, pallet counts) to prepare accurate domestic and international shipping quotes. Apply critical thinking and attention to detail to ensure cost-effective and compliant logistics solutions. 3. International Trade & Compliance Knowledge Demonstrate working knowledge of Incoterms and international shipping documentation, including Shipper's Letter of Instruction (SLI), dock receipts and import documents such as TSCA. Ensure compliance with international trade regulations and hazardous material shipping requirements (DOT, IATA, and IMDG). 4. Documentation & Shipment Coordination Prepare and manage shipping documentation, including Bills of Materials and customs paperwork, with a high degree of accuracy. Coordinate with Shipping and Receiving teams to ensure timely and compliant order dispatch. 5. Client Service & Order Management Provide proactive updates to clients and internal teams regarding order status, ensuring transparency and responsiveness. Follow up post-delivery to gather feedback and ensure customer satisfaction. 6. Relationship Management Build and maintain effective relationships with domestic and international shipping agents to support reliable and cost-effective logistics operations. 7. Continuous Improvement & Learning Participate in weekly open order realization meetings and contribute to process improvements. Demonstrate a commitment to ongoing learning about international logistics, chemical product handling, and the company's business model. 8. Collaboration & Flexibility Support adjacent functions such as production planning, inventory control, and raw material purchasing as needed. Exhibit adaptability and a team-oriented mindset in a dynamic work environment. 9. Reporting & Accountability Maintain clear records and provide timely updates and reports to management. Take ownership of assigned responsibilities and escalate issues appropriately. Qualifications: • Bachelor's Degree in Education, English, Business, or Communication or equivalent experience • Strong phone skills • Excellent customer service and client management skills • Strong computer skills, including MS Word, Excel and Outlook • Excellent written and verbal communication skills • Must be able to read, write, speak, and understand English • Ability to multi-task, prioritize, and manage time effectively • Good working knowledge of, or the ability to learn, Enterprise Resource Planning (ERP) systems • Ability to learn chemical properties and how BioSpectra's products are used • Ability and willingness to work from all BioSpectra facilities

BioSpectra, Inc. is a privately held, family-oriented organization and a U.S. based manufacturer of GMP pharmaceutical-grade ingredients, including API's, excipients, GMP process chemicals, and bulk GMP buffers and solutions. BioSpectra, Inc. currently has facilities located in Bangor, Wind Gap, Stroudsburg, PA and Scarborough, Canada. Position Summary: The Maintenance Technician III is responsible for conducting machine setup, troubleshooting, repairs, and preventive machine service to ensure continuous efficient and safe operations. Major Roles and Responsibilities: 1. Technical Expertise: Maintains and installs process and related equipment with precision and efficiency. Performs scheduled and emergency maintenance, including mechanical, pneumatic, and hydraulic troubleshooting and repairs. Diagnoses and repairs complex mechanical and electrical systems using appropriate tools and techniques. 2. Problem Solving & Analytical Thinking Reads and interprets equipment manuals, blueprints, schematics, and work orders to identify and resolve issues. Apply logical thinking and technical knowledge to troubleshoot and resolve equipment malfunctions. 3. Communication & Collaboration Communicate effectively with peers, supervisors, and upper management regarding maintenance activities and equipment status. Demonstrates leadership by coaching and mentoring junior mechanics and team members. Motivates others and fosters a collaborative team environment. 4. Safety & Compliance Promotes and adheres to safety protocols, including OSHA regulations and company safety policies. Prioritizes safety during all maintenance tasks and ensures proper use of PPE. Handles tools and equipment responsibly to prevent accidents and ensure a safe work environment. 5. Planning & Execution Perform work orders assigned, ensuring timely and accurate completion. Conducts preventative maintenance according to schedule and operational needs. Uses power tools and shop tools effectively to complete tasks. 6. Documentation & Record Keeping Accurately documents maintenance activities in applicable logs and systems. Maintains organized records to support compliance and operational efficiency. 7. Housekeeping & Workplace Standards Maintains clean and orderly workspaces in accordance with company standards. Demonstrates responsibility for equipment and facility cleanliness. 8. Adaptability & Initiative Respond effectively to unscheduled repairs and changing priorities. Takes initiative to perform additional duties as assigned by management. Qualifications: • Five years of related mechanical or building experience. • Technical training; exposure to high-speed equipment. • Demonstrate mechanical aptitude to work with various tools and machines. • Good math skills for measuring and cutting. • Must be able to read, write, speak, and understand English. • Must be able to push, pull, lift, bend, stoop, crawl, climb, and twist throughout the shift. • Detail Oriented. • Ability to learn CGMP and Safety programs. • Must be able to communicate effectively through departments across the organization.

Process Dev BIOSPECTRA PROCESS DEVELOPMENT ENGINEERING SPECIALIST If you like the idea of leveraging your engineering skills to become part of a growing chemical manufacturing company and a major supplier to the bio-pharmaceutical industry, this may be the job for you! BioSpectra is seeking a Process Development Engineer to execute projects in support of BioSpectra's process development initiatives. These projects include development/validation of new products and processes, increasing capacity of current products, improving safety, compliance, cost of manufacturing and other areas of continuous improvement. Major Roles & Responsibilities: The ideal candidate will be able to perform the following responsibilities. Project Management: Executes process and product development projects as assigned by effectively planning, monitoring and taking action to resolve issues that arise in a timely manner. Communicates the status of these projects to members of management, as needed. Process Engineering & Design: Assists in the design of chemical manufacturing processes by providing input into the process design, process path and equipment selection to ensure the effectiveness of the process. Process Optimization: Evaluates manufacturing processes, development/manufacturing batch records and operational procedures and makes recommendations to leadership to improve increase throughput, reduce costs and improve safety. Equipment Selection & Installation: Provides input into the design and selection of process equipment and troubleshoot process equipment and utilities as required. Change Management: Works closely with process validation to ensure that changes to process and equipment are properly handled within BioSpectra's change management procedures. Training: Trains manufacturing personnel in how to best operate manufacturing equipment to ensure manufactured product meets required specifications Documentation: Ensures executed development plans are documented, reviewed and approved by appropriate personnel. Documents work performed in batch records, validation protocols, logbooks, laboratory notebooks, etc. Environmental, Health & Safety Assessment: Works closely with EHS management to assess manufacturing processes and equipment with respect to safety and environmental impact and make recommendations as to changes needed. Qualifications: The ideal candidate will have a degree in chemical engineering or other related field and/or commensurate experience. Five or more years' experience in process engineering for a chemical, food, materials bio- pharmaceutical manufacturer. Must have demonstrated effective working knowledge and ability managing projects, analyzing data, using statistical methods and engineering principles, with material/chemical processing equipment, and technical writing. Must be able to communicate effectively in writing and orally. Must be able to learn how to effectively develop batch procedures and manage process changes and validations per regulatory guidelines. Must be able to work effectively with Microsoft Word, Excel, and other applicable statistical and engineering software. In addition, the ideal candidate will have the following qualities which will be critical to their success in this role. Technical Expertise: Demonstrated excellence in designing, and optimizing manufacturing processes, ideally with experience in driving continuous process improvements, with a general working knowledge of SPC, DOE, Six Sigma, Lean and/or other process improvement methodology and systems. Achieves Results: Results-orientation with a proven ability to deliver tangible outcomes and measurable results. Problem-Solving & Decision-making: Demonstrated technical and mechanical ability to diagnose, decide on a course of action and resolve manufacturing process issues. Communication: Ability to write, orally communicate and effectively communicate technical information in a concise and understandable way. Software Technology: Demonstrated ability to use software technology and systems, including statistical software to assist the organization in driving process performance excellence. If you believe you have the experience and the right stuff to be part of BioSpectra's Process Development team, please reach out to us!

The Controls Engineer is responsible for programming and maintaining automated control systems and troubleshooting these systems to diagnose and resolve issues in order to minimize process downtime. The ideal candidate will be able to demonstrate an effective working knowledge of PLC programming and overall knowledge of automation technologies, DCS, and HMI systems. The ideal candidate for this position is someone who is a self-starter and aspires to assume ownership for maintaining the automated control systems for a growing manufacturing organization in the bio-pharmaceutical industry. Key Responsibilities: Programming & Scripting: Write and maintain control code, scripts, and programs (e.g., such as PLC Siemens, Allen-Bradley) to control automated systems. Troubleshooting & Support: Troubleshoot automation systems, diagnose and resolve issues promptly to minimize downtime. Testing & Calibration: Test automation systems, calibrate equipment, and conduct performance evaluations. Documentation: Create and maintain clear documentation for automation systems, including design specifications, maintenance procedures, and troubleshooting guides. Safety & Compliance: Ensure all automation systems comply with safety regulations, industry standards, and company policies. Continuous Improvement: Proactively suggest improvements for automation systems, processes, and tools to enhance overall efficiency and performance. System Optimization: As the candidate gains more experience with BioSpectra automated systems, they will take on greater responsibilities for optimizing these systems and processes, in order to increase efficiency, reduce downtime, and enhance product quality. Skills & Qualifications: Education: Bachelor's degree in Electrical Engineering, Mechanical Engineering, Computer Science, or a related field, or the equivalent work experience. Technical Experience: A minimum of three to five years of related professional experience programming PLCs and maintaining automated control and HMI systems. Industry & Equipment Experience: Experience with biopharmaceutical, chemical, food or materials manufacturing controls, valve controls and utility control systems. Technical Skills: Proficient in PLC programming languages (e.g. Siemens, Allen-Bradley) Demonstrated knowledge of C-more, Do-more software (HMI) and industrial control systems. Familiarity with sensors, actuators, and other automation hardware. Knowledge of networking, data communication, and industrial protocols. Performance Attributes: Problem-Solving: Effective analytical, critical thinking and troubleshooting skills. Training and Development: Capability and comfortability to train and develop others. Communication: Excellent written and verbal communication skills, with the ability to explain technical concepts to non-technical team members. First Shift M-F

Join our team at BioSpectra, Inc., where we lead the way in delivering high-purity ingredients to the top 25 pharmaceutical companies globally. We are dedicated to maintaining the highest standards of excellence in the industry. BioSpectra, Inc. is a privately held, family-oriented organization and a U.S. based manufacturer of GMP pharmaceutical-grade ingredients, including API's, excipients, GMP process chemicals, and bulk GMP buffers and solutions. BioSpectra, Inc. currently has facilities located in Bangor, Wind Gap, Stroudsburg, PA and Scarborough, Canada. Position Summary The Senior HVAC Technician will schedule, oversee, and at times perform installation, qualification and maintenance of plumbing, gas, heating, ventilation and refrigerant based units for all BioSpectra facilities. Major Roles and Responsibilities •Organize and lead team of HVAC technicians and plumbers •Schedules the install of new heating, ventilation, air conditioning and refrigerant based units •Schedules the install of ductwork and thermostats to control HVAC systems •Schedules routine maintenance on HVAC systems to ensure they operate properly •Inspects and troubleshoots problems with existing HVAC units •Schedules the install of replacement parts on exiting HVAC units •Reviews part lists submitted by direct reports •Complies with company and industry safety standards •Interacts with other trades to ensure effective communication for the execution of all projects •Assists maintenance department with qualified processes and related equipment. •Provides support in the qualification of new processes and related equipment. •Assists in performing scheduled equipment preventive maintenance. •Assists other operation employees as needed. •Maintains good housekeeping practices. •Wears appropriate PPE for the duties being performed •Other duties may be assigned as deemed appropriate by management Qualifications •Successful completion of vocational school or technical college or apprenticeship program; or at least three years of experience via on-the-job training required •Must have experience with industrial/commercial HVAC operations •Ability to understand directions and read blue prints •Ability to solve mathematical problems quickly and accurately •Ability to properly care for and use tools of the trade •Thorough understanding of carpentry principles and methods •Must have manual dexterity, a good sense of balance and excellent hand-eye coordination •Work well as part of a team •Detail Oriented •Ability to learn cGMP and safety programs.

If you're looking for an opportunity to be challenged in your career, this may be the job for you! BioSpectra is experiencing unprecedented growth and is looking for a skilled Calibration Specialist. BioSpectra, Inc. is a privately held, family-oriented organization and a U.S.-based manufacturer of GMP pharmaceutical-grade ingredients, including API's, excipients, GMP process chemicals, and bulk GMP buffers and solutions. BioSpectra currently has facilities located in Bangor, Wind Gap, and Stroudsburg, PA. Why you should join BioSpectra? Direct Placement-Comprehensive Benefits Package (Health, Dental, Vision, & Life Insurance $50,000) 401K Retirement Savings Plan - Company matches $2 per $1 of employee contribution on the first 4% Paid Time Off Programs include vacation (12 Days), sick (24 Hrs) & personal time (16 Hrs) plus 11 paid holidays Opportunities for professional and personal development & growth include tuition reimbursement Support our current customers who are the top 25 pharmaceutical companies in the world Job Summary: The Calibration Specialist is responsible for overseeing calibration equipment and performing calibrations on critical measuring tools, systems, and equipment. This role also manages the documentation, organization, planning, and execution of the overall calibration program. Essential Duties and Responsibilities: • Executes in-house calibrations on critical instrumentation. • Assigns calibration tasks to calibration technicians to execute calibration activities. • Coordinates and oversees service provider calibrations; sending instrumentation out and working with outside vendors. • Troubleshoots calibration equipment or devices. • Performs trend analysis of calibration equipment and reviews calibration data. • Calibration data entry and review within ProCal system. • Order spare parts and equipment associated with Critical Measuring Tools • Coordinates Calibration activity with approved outside vendors • Completes internal calibration reports for critical measure tools and updating information in Procal • Complete discrepancy investigations, suggest corrective and preventative actions related to the calibration program or record. • Communicates all third party scheduled calibrations on site to key personnel to prepare for their site visits. • Works with all applicable departments on the timely scheduling of calibrations. • Ensures all critical measuring tools are labeled correctly for calibration record and use range. • Prepares equipment and tools for calibrations. Qualifications: • At least 5 years' experience in calibration activities in a GMP environment. • Computer system understanding • Highly Organized • Attention to detail • Good written and verbal communication skills Physical Requirements: • Lift up to 50 lbs. occasionally lift up to 100lbs • Prolonged periods sitting at a desk and working on a computer • Ability to see and distinguish color • Repeating motion that may include wrists, hands, and fingers Work Hours: • Non-Exempt Position; Monday to Friday 7am to 3:30pm • Minimum of 40-45 Hours Week, or other agreed upon documented schedule • Ability and willingness to work from all BioSpectra facilities

BIOSPECTRA SENIOR ERP BUSINESS APPLICATION SPECIALIST If you like the idea of being a a Business Application Specialist and part of a growing company that is a major supplier to the bio-pharmaceutical industry, this may be the job for you! BioSpectra is seeking a Senior ERP - Business Application Specialist to work directly with management and subject matter experts to identify requirements, implement solutions, and manage the life cycle of relevant business applications. This is an excellent opportunity for an individual who has the technical skills and leadership capabilities to provide business application solutions to management in their day-to-day business challenges. Major Roles & Responsibilities: ERP System: Serves as the primary owner and subject matter expert for the Organizational ERP system and associated satellite systems (including integrated Warehouse Management System and Business Intelligence System) Other Business Applications & Software: Administers additional Organizational business applications including product labeling systems, regulatory submission software, and equipment calibration system. Business Intelligence: Uses Business Intelligence tools to develop and deliver a wide range of dashboards and reports to multiple departments. User Support: Provides excellent support to end user base, including development and delivery of training materials. Collaborates with key members of the IT Infrastructure team to ensure consistent, reliable application experience. Application Training: Actively cross trains and aids in the support of other organizational applications including: LIMS Documents and Training System Electronic Batch Record System Electronic Maintenance System Other business systems as required Business Requirements: Leads requirements gathering sessions, documenting requirements, and converting them to tasks or implementation of project plans. Continuous Improvement: Actively seeks out inefficiencies within relevant business processes and proposes technology-driven solutions. Ensures relevant systems are continuously updated throughout the system lifecycle, in compliance with relevant internal and regulatory agency requirements. System Integration: Completes system integration projects by self-developing integrations or leading projects with external vendors (project and system-dependent). Documentation: Creates and maintains detailed documentation of all system modifications, customizations, configurations, and enhancements IT System Standard Operating Procedures: Creates and maintains system SOPs where required. Database Administration: Acts as administrator for all organizational databases. Software Validation: Participates as a key member during relevant software validation efforts. Qualifications: The following qualifications are required: Education: Four-year college or university program, certificate, or five years' related experience. Experience: Proven experience managing and developing Sage X3 ERP (Other ERP systems may be considered) Experience developing dashboards using common BI tools (Power BI / Tableau / ZAP). Demonstrated experience developing and maintaining application integrations (Cloud and on Premises). Experience working life sciences or pharmaceutical industry is preferred. Familiarity with GxP / Computer System Validation lifecycle is preferred. The ideal candidate will have the following experience or attributes: Excellent customer service and communication skills Strong ability to work independently or in a team setting Strong business process analysis capabilities Report / inquiry development SQL / database management Crystal reports Windows Server and Microsoft SQL Server General Information Technology Skills pertaining to networking and security best practices If you believe you have the technical skills and the leadership capabilities to be a senior business applications specialist for a high growth company, please reach out to us!

BioSpectra, Inc. is a privately held, family-oriented organization and a U.S. based manufacturer of GMP pharmaceutical-grade ingredients, including API's, excipients, GMP process chemicals, and bulk GMP buffers and solutions. BioSpectra, Inc. currently has facilities located in Bangor, Wind Gap, Stroudsburg, PA and Scarborough, Canada. Position Summary: The Construction Technician III will perform, organize, and plan construction projects and repairs for all BioSpectra facilities and properties. Major Roles and Responsibilities: 1. Technical Proficiency: Demonstrates skill in building construction and repair techniques including: Painting, carpentry, sheet rocking, flooring Plumbing, basic electrical work Masonry, cement work HVAC systems and roofing Operates hand and power tools safely and effectively to complete assigned projects. 2. Safety & Compliance Adheres to local building codes, safety regulations, and company policies. Always wears appropriate personal protective equipment (PPE). Ensures waste disposal complies with federal, state, and local regulations. 3. Quality & Cleanliness Maintains high standards of workmanship and attention to detail. Practices good housekeeping and ensures work areas are clean and organized. Completes clean-up duties following project completion. 4. Teamwork & Collaboration Works effectively with other craft employees to complete projects. Communicate clearly and respectfully with supervisors and team members. Follows instructions and contributes to team goals. 5. Learning & Adaptability Demonstrates willingness to learn through on-the-job training. Adapts to changing priorities and tasks assigned by management. 6. Planning & Organization Plans and organizes work orders in accordance with cGMP guidelines and company SOPs. Manages time effectively to meet deadlines and project goals. Professionalism & Accountability Takes responsibility for assigned duties and follows through on commitments. Qualifications: •Successful completion of vocational school or technical college or apprenticeship program; or at least three years of experience via on-the-job training required •Ability to understand directions and read blue prints •Ability to solve mathematical problems quickly and accurately •Ability to properly care for and use tools of the trade •Thorough understanding of carpentry principles and methods •Must have manual dexterity, a good sense of balance and excellent hand-eye coordination •Work well as part of a team •Detail Oriented •Ability to learn cGMP and safety programs.

Job Description The Logistics Coordinator is responsible for the processing and realization of complicated Bio Pharmaceutical shipments (Realization, and Fulfillment). The Logistics Coordinator plays a critical role in ensuring the accurate, timely, and compliant movement of goods across domestic and international channels. This position requires a detail-oriented professional with strong communication and analytical skills who can collaborate effectively across departments and with external partners. Success in this role depends on the ability to build strong relationships, proactively solve problems, and continuously improve logistics processes to support customer satisfaction and operational excellence. Major Roles & Responsibilities: 1. Commercial & Cross-Functional Communication Serve as the primary logistics liaison for commercial teams, demonstrating strong interpersonal and communication skills. Ensure timely, accurate, and professional communication with internal teams(QA, QC, Purchasing, Commercial, Manufacturing) and external clients to support seamless order fulfillment. 2. Data Analysis & Quote Preparation Collect and analyze key shipment data (e.g., freight rates, dimensions, pallet counts) to prepare accurate domestic and international shipping quotes. Apply critical thinking and attention to detail to ensure cost-effective and compliant logistics solutions. 3. International Trade & Compliance Knowledge Demonstrate working knowledge of Incoterms and international shipping documentation, including Shipper's Letter of Instruction (SLI), dock receipts and import documents such as TSCA. Ensure compliance with international trade regulations and hazardous material shipping requirements (DOT, IATA, and IMDG). 4. Documentation & Shipment Coordination Prepare and manage shipping documentation, including Bills of Materials and customs paperwork, with a high degree of accuracy. Coordinate with Shipping and Receiving teams to ensure timely and compliant order dispatch. 5. Client Service & Order Management Provide proactive updates to clients and internal teams regarding order status, ensuring transparency and responsiveness. Follow up post-delivery to gather feedback and ensure customer satisfaction. 6. Relationship Management Build and maintain effective relationships with domestic and international shipping agents to support reliable and cost-effective logistics operations. 7. Continuous Improvement & Learning Participate in weekly open order realization meetings and contribute to process improvements. Demonstrate a commitment to ongoing learning about international logistics, chemical product handling, and the company's business model. 8. Collaboration & Flexibility Support adjacent functions such as production planning, inventory control, and raw material purchasing as needed. Exhibit adaptability and a team-oriented mindset in a dynamic work environment. 9. Reporting & Accountability Maintain clear records and provide timely updates and reports to management. Take ownership of assigned responsibilities and escalate issues appropriately. Qualifications: • Bachelor's Degree in Education, English, Business, or Communication or equivalent experience • Strong phone skills • Excellent customer service and client management skills • Strong computer skills, including MS Word, Excel and Outlook • Excellent written and verbal communication skills • Must be able to read, write, speak, and understand English • Ability to multi-task, prioritize, and manage time effectively • Good working knowledge of, or the ability to learn, Enterprise Resource Planning (ERP) systems • Ability to learn chemical properties and how BioSpectra's products are used • Ability and willingness to work from all BioSpectra facilities

Job Description BioSpectra, Inc. is a privately held, family-oriented organization and a U.S. based manufacturer of GMP pharmaceutical-grade ingredients, including API's, excipients, GMP process chemicals, and bulk GMP buffers and solutions. BioSpectra, Inc. currently has facilities located in Bangor, Wind Gap, Stroudsburg, PA and Scarborough, Canada. Position Summary: A Security Technician I is responsible for overseeing and maintaining a safe and secure environment for BioSpectra's personnel, property, and assets. The security officer may also manage and/or implement security protocols related to the storage of confidential information and documents. Overnight shift, varying schedule. Major Roles and Responsibilities: • Greets visitors, contractors and registers each at facility entrance in accordance with Building Access and Security SOP. Contacts proper personnel to escort them inside the facility. • 24/7 CCTV surveillance and alarm system monitoring. Saves incident surveillance for future review. • Monitor television and Internet resources, within the guidelines of the BioSpectra Information Services Usage Agreement, for impending weather and traffic conditions. • Run daily test to ensuring all CCTV(s) are functional; report technical malfunctions • Log daily activities, incidents and alarm activities into the pass-down log • Receives vendors and delivery vehicles. Directs vehicles to appropriate dock or parking location in accordance with communication from Supply Chain staff. • Verifies shipments entering and exiting the facility grounds are authorized to do so and are secured • Escorts and supports pest control service • Answers, and transfers, internal and external phone calls in accordance with BioSpectra policy • Maintains clean workspaces • Prevents loss and damage by ensuring trespassers and/or risks are mitigated • Completes security incident reports in a timely manner • Completes debris, ice and snow removal to prevent risk to traffic • Maintains employee roster for entering and exiting applicable facility for emergency responses activities. • Secures premises and personnel by patrolling property, building and facility access points • Dispatch Security personnel to all alarm notifications to investigate alarms. • Ensures swift and effective communication of any emergency on site to applicable leadership or emergency responders • Performs escorting responsibilities for visitors or contractors entering the facility, when applicable • Assists with medical, fire and security emergencies, calling and/or coordinating with emergency services and local authorities • Maintain active communications and transfers through phone and radio to security officers. • Receives regulatory agents and communicates their arrival in accordance with BioSpectra procedures • Completes AED, fire extinguishers, spill kits, eye wash, and first aid stations inspections • Assists Human Resources with sensitive events. • Staying up-to-date with changes to security regulations and industry best practices, and making recommendations for continuous improvement. • Performs other related duties as assigned. Qualifications: • High school diploma or equivalent; previous law enforcement or military background preferred. • Experience on a security team with CCTV usage or a similar role in a corporate or industrial setting. • Knowledge of security protocols and emergency response procedures. • Excellent leadership and communication skills. • Ability to handle high-pressure situations calmly andefficiently. • Good analytical and problem-solving skills. • Strong attention to detail. • Physical fitness and the ability to stand or walk for extended periods. • Excellent written and verbal communication skills. • Ability to work with confidential and classified information. • Proficient with Microsoft Office Suite or related software.

Job Description Process Dev BIOSPECTRA PROCESS DEVELOPMENT ENGINEERING SPECIALIST If you like the idea of leveraging your engineering skills to become part of a growing chemical manufacturing company and a major supplier to the bio-pharmaceutical industry, this may be the job for you! BioSpectra is seeking a Process Development Engineer to execute projects in support of BioSpectra's process development initiatives. These projects include development/validation of new products and processes, increasing capacity of current products, improving safety, compliance, cost of manufacturing and other areas of continuous improvement. Major Roles & Responsibilities: The ideal candidate will be able to perform the following responsibilities. Project Management: Executes process and product development projects as assigned by effectively planning, monitoring and taking action to resolve issues that arise in a timely manner. Communicates the status of these projects to members of management, as needed. Process Engineering & Design: Assists in the design of chemical manufacturing processes by providing input into the process design, process path and equipment selection to ensure the effectiveness of the process. Process Optimization: Evaluates manufacturing processes, development/manufacturing batch records and operational procedures and makes recommendations to leadership to improve increase throughput, reduce costs and improve safety. Equipment Selection & Installation: Provides input into the design and selection of process equipment and troubleshoot process equipment and utilities as required. Change Management: Works closely with process validation to ensure that changes to process and equipment are properly handled within BioSpectra's change management procedures. Training: Trains manufacturing personnel in how to best operate manufacturing equipment to ensure manufactured product meets required specifications Documentation: Ensures executed development plans are documented, reviewed and approved by appropriate personnel. Documents work performed in batch records, validation protocols, logbooks, laboratory notebooks, etc. Environmental, Health & Safety Assessment: Works closely with EHS management to assess manufacturing processes and equipment with respect to safety and environmental impact and make recommendations as to changes needed. Qualifications: The ideal candidate will have a degree in chemical engineering or other related field and/or commensurate experience. Five or more years' experience in process engineering for a chemical, food, materials bio- pharmaceutical manufacturer. Must have demonstrated effective working knowledge and ability managing projects, analyzing data, using statistical methods and engineering principles, with material/chemical processing equipment, and technical writing. Must be able to communicate effectively in writing and orally. Must be able to learn how to effectively develop batch procedures and manage process changes and validations per regulatory guidelines. Must be able to work effectively with Microsoft Word, Excel, and other applicable statistical and engineering software. In addition, the ideal candidate will have the following qualities which will be critical to their success in this role. Technical Expertise: Demonstrated excellence in designing, and optimizing manufacturing processes, ideally with experience in driving continuous process improvements, with a general working knowledge of SPC, DOE, Six Sigma, Lean and/or other process improvement methodology and systems. Achieves Results: Results-orientation with a proven ability to deliver tangible outcomes and measurable results. Problem-Solving & Decision-making: Demonstrated technical and mechanical ability to diagnose, decide on a course of action and resolve manufacturing process issues. Communication: Ability to write, orally communicate and effectively communicate technical information in a concise and understandable way. Software Technology: Demonstrated ability to use software technology and systems, including statistical software to assist the organization in driving process performance excellence. If you believe you have the experience and the right stuff to be part of BioSpectra's Process Development team, please reach out to us!

BioSpectra, Inc. is a privately held, family-oriented organization and a U. S. based manufacturer of GMP pharmaceutical-grade ingredients, including API's, excipients, GMP process chemicals, and bulk GMP buffers and solutions. BioSpectra, Inc. currently has facilities located in Bangor, Wind Gap, Stroudsburg, PA and Scarborough, Canada.

Job Description Controls Engineer The Controls Engineer is responsible for programming and maintaining automated control systems and troubleshooting these systems to diagnose and resolve issues in order to minimize process downtime. The ideal candidate will be able to demonstrate an effective working knowledge of PLC programming and overall knowledge of automation technologies, DCS, and HMI systems. The ideal candidate for this position is someone who is a self-starter and aspires to assume ownership for maintaining the automated control systems for a growing manufacturing organization in the bio-pharmaceutical industry. Key Responsibilities: Programming & Scripting: Write and maintain control code, scripts, and programs (e.g., such as PLC Siemens, Allen-Bradley) to control automated systems. Troubleshooting & Support: Troubleshoot automation systems, diagnose and resolve issues promptly to minimize downtime. Testing & Calibration: Test automation systems, calibrate equipment, and conduct performance evaluations. Documentation: Create and maintain clear documentation for automation systems, including design specifications, maintenance procedures, and troubleshooting guides. Safety & Compliance: Ensure all automation systems comply with safety regulations, industry standards, and company policies. Continuous Improvement: Proactively suggest improvements for automation systems, processes, and tools to enhance overall efficiency and performance. System Optimization: As the candidate gains more experience with BioSpectra automated systems, they will take on greater responsibilities for optimizing these systems and processes, in order to increase efficiency, reduce downtime, and enhance product quality. Skills & Qualifications: Education: Bachelor's degree in Electrical Engineering, Mechanical Engineering, Computer Science, or a related field, or the equivalent work experience. Technical Experience: A minimum of three to five years of related professional experience programming PLCs and maintaining automated control and HMI systems. Industry & Equipment Experience: Experience with biopharmaceutical, chemical, food or materials manufacturing controls, valve controls and utility control systems. Technical Skills: Proficient in PLC programming languages (e.g. Siemens, Allen-Bradley) Demonstrated knowledge of C-more, Do-more software (HMI) and industrial control systems. Familiarity with sensors, actuators, and other automation hardware. Knowledge of networking, data communication, and industrial protocols. Performance Attributes: Problem-Solving: Effective analytical, critical thinking and troubleshooting skills. Training and Development: Capability and comfortability to train and develop others. Communication: Excellent written and verbal communication skills, with the ability to explain technical concepts to non-technical team members. First Shift M-F

Job Description Join our team at BioSpectra, Inc., where we lead the way in delivering high-purity ingredients to the top 25 pharmaceutical companies globally. We are dedicated to maintaining the highest standards of excellence in the industry. BioSpectra, Inc. is a privately held, family-oriented organization and a U.S. based manufacturer of GMP pharmaceutical-grade ingredients, including API's, excipients, GMP process chemicals, and bulk GMP buffers and solutions. BioSpectra, Inc. currently has facilities located in Bangor, Wind Gap, Stroudsburg, PA and Scarborough, Canada. Job Summary: This position is responsible for ensuring that equipment, systems, and processes are qualified and validated in accordance with regulatory requirements and BioSpectra's standards. This includes developing, executing, and reporting on equipment, instrumentation, and control system qualifications and re-qualifications Essential Job Duties & Responsibilities: Create Qualification Protocols (IQ, OQ, PQ) for equipment, systems, and processes. Research & upload all support documentation into BioSpectra's document management system as required. Complete Risk Assessments for all qualifications by utilizing Equipment and Process FMEAs (Failure mode and effects analysis). Document the execution of Qualifications and monitors the execution of qualification protocols to ensure successful completion of documentation and compliance with established procedures. Ensure the execution of qualification protocols are completed in a timely manner and within Manufacturing's timeframes. Train personnel executing qualification protocols to understand instructions, accurate documentation practices and ensure compliance to established procedures. Create standard operating procedures for new or current equipment as necessary. Develop and execute temperature and humidity mapping studies within controlled storage areas and report on the execution. Evaluate the impact of any process and/or equipment changes to determine if qualifications and/or re-qualification of process equipment or process measuring tools is required. Work closely with multiple divisions to coordinate qualification efforts and resolve any potential issues through BioSpectra's change control program or CAPA program Review and approve external manufacturer qualification documentation to ensure it aligns with BioSpectra standards, and execute potential factory acceptance testing (FAT) or site acceptance testing (SAT) Assist in preparing for internal and external audits, ensuring all qualification documentation is readily available and in compliance Maintain an accurate database of completed equipment and system qualifications, and equipment qualification status to ensure continued process verification and monitoring of all current and pending qualified systems. Apply the appropriate qualification status in key areas to ensure the qualification status of equipment or systems in communicated to key personnel. Provide timelines for the qualification of equipment, processes or systems. Perform re-qualification of manufacturing equipment and systems in accordance with the current Equipment Qualification Master Plan and associated guidance documents to demonstrate that the equipment performs as intended throughout specified operating and performance ranges. Ensure all critical measuring tools are calibrated as required before the execution of a qualification protocol and files the associated documentation as needed. Identify and implement process improvements to enhance efficiency and effectiveness of the qualification process. Qualifications: Education/Certifications: Bachelor's degree in Science, Engineering or other related discipline, or commensurate experience in chemical, or pharmaceutical manufacturing, ideally with a cGMP manufacturer. Experience: Minimum of one year of equipment qualifications experience at GMP manufacturer. Advanced knowledge of cGMP requirements and practices and experience in an FDA registered facility. Effective working knowledge of performing and understanding qualifications for instrumentation and control systems equipment. Special Skills & Competencies: Must have accomplished analytical, oral communication and technical writing abilities and be able to read, understand and communicate in English. Must be able to understand, analyze and interpret the BioSpectra quality system and related documents. Must be able to logically assess situations, manage multiple complex activities, and make competent, timely decisions amidst changing priorities. Must have advanced knowledge and capability to understand mechanical systems, processes and equipment. Ideally, will have advanced knowledge of instrumentation and control systems equipment. Ability to work at an advanced level with Microsoft Word, Excel, and other applicable software systems as necessary.

Job Description Join our team at BioSpectra, Inc., where we lead the way in delivering high-purity ingredients to the top 25 pharmaceutical companies globally. We are dedicated to maintaining the highest standards of excellence in the industry. BioSpectra, Inc. is a privately held, family-oriented organization and a U.S. based manufacturer of GMP pharmaceutical-grade ingredients, including API's, excipients, GMP process chemicals, and bulk GMP buffers and solutions. BioSpectra, Inc. currently has facilities located in Bangor, Wind Gap, Stroudsburg, PA and Scarborough, Canada. Position Summary The Senior HVAC Technician will schedule, oversee, and at times perform installation, qualification and maintenance of plumbing, gas, heating, ventilation and refrigerant based units for all BioSpectra facilities. Major Roles and Responsibilities •Organize and lead team of HVAC technicians and plumbers •Schedules the install of new heating, ventilation, air conditioning and refrigerant based units •Schedules the install of ductwork and thermostats to control HVAC systems •Schedules routine maintenance on HVAC systems to ensure they operate properly •Inspects and troubleshoots problems with existing HVAC units •Schedules the install of replacement parts on exiting HVAC units •Reviews part lists submitted by direct reports •Complies with company and industry safety standards •Interacts with other trades to ensure effective communication for the execution of all projects •Assists maintenance department with qualified processes and related equipment. •Provides support in the qualification of new processes and related equipment. •Assists in performing scheduled equipment preventive maintenance. •Assists other operation employees as needed. •Maintains good housekeeping practices. •Wears appropriate PPE for the duties being performed •Other duties may be assigned as deemed appropriate by management Qualifications •Successful completion of vocational school or technical college or apprenticeship program; or at least three years of experience via on-the-job training required •Must have experience with industrial/commercial HVAC operations •Ability to understand directions and read blue prints •Ability to solve mathematical problems quickly and accurately •Ability to properly care for and use tools of the trade •Thorough understanding of carpentry principles and methods •Must have manual dexterity, a good sense of balance and excellent hand-eye coordination •Work well as part of a team •Detail Oriented •Ability to learn cGMP and safety programs.

Join our team at BioSpectra, Inc., where we lead the way in delivering high-purity ingredients to the top 25 pharmaceutical companies globally. We are dedicated to maintaining the highest standards of excellence in the industry. Currently we are looking for a Chemical Manufacturing Technician to kickstart their career with us in either the Bangor or East Stroudsburg location. We are currently hiring for day shift and night shift and must have the flexibility to work/travel between the Bangor and East Stroudsburg location. BioSpectra, Inc. is a privately held, family-oriented organization and a U.S. based manufacturer of GMP pharmaceutical-grade ingredients, including API's, excipients, GMP process chemicals, and bulk GMP buffers and solutions. BioSpectra, Inc. currently has facilities located in Bangor, Wind Gap, Stroudsburg, PA and Scarborough, Canada. Position Summary The Chemical Manufacturing Technician I will run all chemical manufacturing processes in compliance with all associated quality systems. Packs and ships all products. Maintains processes in their validated or compliant state. Major Roles and Responsibilities: •Reads and follows written and electronic batch records •Ability to record data in accordance with Good Manufacturing Practices (GMP) •Operates Powered Industrial Vehicles to move product, as needed •Handles lab equipment to monitor product dryness using lab moisture balance •Cleans reactors, filters and other process related equipment, process rooms, general cleaning •Records appropriate steps on batch record and associated documents •Understands and complies with quality regulations as they relate to job responsibilities •Complies with good housekeeping and safety rules •Understands various process pumps •Operates various process pumps •Troubleshoots process related equipment- type of equipment is dependent on operator level •Shovels product from bin into dryer feed hopper •Scoops product from drums and weighs amounts •Rolls drums onto and off from skids •Accurately weighs material on scales during final packaging in accordance with packaging documentation. •Monitors in-process batches with regard to temperature, clarity, volume, etc. •Documents value points per SOP •Takes bags off skids and empties contents into reactor •Changes cartridges on various filters •Continuous Processes •Frequent Respirator use •Other duties may be assigned as deemed appropriate by management Qualifications: •High School diploma or GED. •Ability to perform simple mathematical calculations using a calculator. •Ability to accurately read and take measurements including reading a tape measure. •Ability to read and interpret/follow production procedures. •Must be able to read, write, speak, and understand English. Physical Requirements: •Movement - Standing and Walking for up to 12 hours of the shift. Walking up to 5 miles a day. •Lifting & Moving - Must be able to lift and carry 20 to 80 lbs. repeatedly multiple times in a shift. Pushing & pulling up to 200 lbs. •Other Movements - Bending and reaching required multiple times per shift. Crouching, Stooping and Kneeling a moderate amount of time per shift. Climbing stairs, ladders, scaffolds and ramps required multiple times throughout shift including but not limited to climbing height up to 12 feet. •Other Physical Requirements - Use of a computer and keyboard throughout the shift. Required to perform handwriting and typing throughout the day. Frequently working with Electronic Batch Records. Occasional forklift use. •Speaking, Hearing & Visual - Must be able to speak clearly and present well to others. Hearing is required constantly throughout shift. Must be able to see near, distant and peripheral objects all the time. •Environmental - Frequent warm climates indoors. Temperatures will vary with conditions and tasks. Exposure to exterior noise as well as internal machinery noise. Must be able to put on personal protective equipment throughout shift. Must be able to work in smaller rooms and/or confined spaces. •Cognitive - Must learn new policies, procedures, retain and perform tasks assigned. Must maintain focus, be alert and aware at all times. Must be able to maintain focus at all times.

Senior Business Application Specialist - ERP