Astrix jobs in Trenton, NJ

Repair/Maintenance & Installation Middlesex County, NJ, US + Added - 02/12/2025 Apply for Job Pay Rate Low: 35 | Pay Rate High: 40 **High Pressure Boiler Operator** **2nd shift: M-F, 3pm-11pm** **Pay: $35-40/hour** We're seeking a skilled Boiler Operator to manage and maintain high-pressure boilers and related equipment in compliance with safety standards. You'll play a critical role in ensuring consistent steam generation, troubleshooting issues, and supporting operational efficiency. **Key Responsibilities** + **Monitor and Operate** : Oversee high-pressure boilers, adjusting controls to maintain optimal steam and pressure levels. + **Inspect and Maintain** : Conduct routine inspections and preventive maintenance on boiler systems, pumps, compressors, and controls. + **Troubleshoot** : Diagnose and resolve equipment issues promptly to minimize downtime. + **Record Keeping** : Maintain accurate logs of operations, maintenance, and safety checks. + **Collaborate** : Work with engineering and maintenance teams on process improvements. + **Safety Compliance** : Follow all safety, health, and environmental regulations. + **Emergency Support** : Assist with emergency response efforts related to boiler systems as needed. **Qualifications** + High school diploma or equivalent; technical training in boiler operation preferred. + Valid High-Pressure Boiler Operator's License or equivalent certification. + 2+ years of experience in high-pressure boiler operation, preferably in an industrial or biotech setting. + Familiarity with boiler control systems, steam distribution, and safety protocols. + Strong problem-solving skills and attention to detail. + Ability to read technical documents and work independently or with a team. **Working Conditions** + Active, on-your-feet role in an industrial environment. + May involve shift work, including nights and weekends. + Exposure to high temperatures, noise, and hazardous conditions (safety gear provided). Ready to take on a vital role in maintaining our facility's operations? Apply today! This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you! INDBH We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

We are seeking an Analytical Scientist to join a reputable pharmaceutical manufacturing company to conduct routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples. ** No Relocation, No C2C Candidates** Pay: Up to $50/hour. RESPONSIBILITIES: Conduct and document chemical analyses for raw materials, in-process goods, and finished products. Design, validate, and resolve issues with analytical methods, including HPLC for cleaning verification. Collect and analyze equipment cleaning validation samples. Prepare Certificates of Analysis, analytical reports, and maintain lab documentation. Peer-review records and support OOS or OOT investigations as per SOPs. Ensure compliance with SOPs, cGMPs, and regulatory requirements. Assist with environmental monitoring and other tasks as assigned. QUALIFICATIONS: 2 years hands-on method development experience (HPLC) Knowledge of cGMPs, pharmacopeia (USP, EP), and regulatory standards (21 CFR Part 210/211/820, ISO). Bachelor's in Chemistry-related discipline with 2+ years of analytical lab experience. This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

Smithers PDS LLC (Pharmaceutical Development Services) brings new drugs to market by providing pre-clinical and clinical services for all phases of drug development. PDS works with customers to develop new methods, validate existing methods, as well as performing the assays necessary to analyze samples from patients on more than 100 clinical trials currently in different phases of the FDA regulated drug approval process. Our expert scientists perform large molecule bioanalysis, assay development, validation, and sample analysis at our GLP, GCP, and CLIA compliant laboratories. Smithers PDS is seeking an experienced Project Manager (Principal Investigator) who will be responsible for being the client's primary point of contact and for the overall conduct of the study. The Project Manager ensures deliverables are met on-time, within scope, and within established quality standards. This position is salaried and is classified as an exempt position. Exempt employees typically work 40 hours or more to adequately perform their responsibilities. Extended work hours may be necessary to support the business in meeting client deliverable commitments. Position is generally eligible for a hybrid work schedule with at least three days on-site once all training requirements have been adequately met and proficient performance is consistently demonstrated. Salary range for this position is $105,000 - $120,000 per year. Salary and job title will be commensurate with experience and qualifications. Smithers PDS offers a comprehensive health insurance package including a choice of 3 medical plans, dental insurance, vision insurance, 401K retirement plan and PTO. Essential Position Responsibilities: Responsible for client interaction and the conduct of studies. Responsible for data interpretation, analysis, and reporting of results for bioanalytical method development and validation. Responsible for the management of preclinical and clinical sample analysis using bioanalytical methods. Maintains and applies experience and knowledge of ligand-binding assays (e.g. ELISA / MSD) or molecular biology assays (e.g. dd PCR, qPCR) applicable to Pharmacokinetic, Biomarker, Immunogenicity, biodistribution studies to support existing and new client studies. Integrates bioanalytical contract research organization (CRO) business objectives in daily activities. Maintains knowledge and applies regulatory and GLP requirements, FDA guidelines, and industry standards for bioanalytical method validation and sample analysis. May mentor, train, or supervise new or less experienced team members. Participates in or contributes to business initiatives, such as process improvement, quality, culture, etc. May perform operational duties in areas of appropriate experience and training. Minimum Qualifications: B.S. / B.A. degree in Biology or related field and a minimum of 10 years of relevant experience in the CRO industry; or, advanced degree in Biology or related field and at least 5 years of relevant experience in the CRO industry. Knowledge of GLP regulations and regulatory guidelines. Excellent communication skills, both oral and written. Strong leadership and organizational skills. Excellent organizational skills. Proficient in the use of basic computer applications such as MS Word and Excel. Ability to multi-task and produce quality analysis while working under the pressure of strict deadlines. Proficient in time management and resource planning. Ability to initiate and implement self-development efforts. Knowledge of Watson LIMS preferred. Ability to effectively interact at all levels of the organization in addition to with clients and regulatory personnel Ability to make decisions and complete assignments with minimal guidance. Ability to establish work priorities and manage shifting priorities. Smither PDS does not accept unsolicited third-party candidate introductions, referrals or resumes. In the event a third-party recruiter submits a resume or refers a candidate without a previously signed vendor agreement, Smithers PDS reserves the right to pursue and hire the candidate(s) without financial liability to such third-party recruiter. #PharmaJobs #LI-MV1

Manufacturing & Utilities Middlesex County, NJ, US + Added - 02/12/2025 Apply for Job Pay Rate Low: 30.00 | Pay Rate High: 40 The Industrial Maintenance Mechanic is responsible for maintaining and repairing facility equipment, handling both electrical and mechanical projects, and ensuring regular preventive maintenance is completed. **Type:** Direct Hire **Location:** Middlesex County, NJ **Pay:** $30 - $40/HR DOE **Shifts Available:** + 2 nd Shift: Monday - Friday, 3:00 PM - 11:30 PM with required training on 1 st (7:00 AM - 3:30 PM) + 3rd Shift: Monday - Friday, 11:00 PM - 7:30 AM with required training on 1 st (7:00 AM - 3:30 PM) **Key Responsibilities** + Diagnose, repair, and maintain manufacturing and production equipment. + Perform preventive maintenance on motors, conveyors, pneumatic and hydraulic systems, and other machinery. + Install and calibrate new injection molding or similar plastic molding equipment. + Use hand and power tools to complete repairs and ensure equipment reliability. + Identify and correct safety hazards to maintain a safe work environment. + Manage maintenance resources efficiently and complete additional tasks as needed. **Qualifications** + High School Diploma/GED + 2+ years of experience as an industrial mechanic (preferred). + Working knowledge of pneumatics, hydraulics, and mechanical schematics. + Strong troubleshooting, communication, and teamwork skills. + Able to lift up to 50 lbs and work overtime or weekends as required. _This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!_ _INDBH_ We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Clinical Monmouth County , NJ, US + Added - 02/06/2025 Apply for Job At Astrix, we're expanding our team to support a diverse range of clients across various industries. We're seeking talented Medical Writers with experience in pharmacovigilance to join us! Our partners range from emerging biotech firms to established pharmaceutical companies. Opportunities are available both remotely and on-site throughout the country! **Responsibilities:** + Prepare and review pharmacovigilance documents including: + Periodic Safety Update Reports (PSURs/PBRERs) + Risk Management Plans (RMPs) + Development Safety Update Reports (DSURs) + Clinical safety narratives + Signal evaluation and benefit-risk assessment reports + Ensure all documents are compliant with regulatory guidelines (ICH, EMA, FDA, etc.), internal SOPs, and quality standards. + Collaborate with cross-functional teams including drug safety, regulatory affairs, clinical development, and biostatistics. + Interpret and synthesize complex clinical and safety data into accurate, concise, and scientifically sound documentation. + Contribute to the development and maintenance of standard operating procedures (SOPs) and templates for pharmacovigilance documents. + Monitor regulatory updates and industry trends to ensure documents remain compliant with changing guidelines. **Qualifications:** + Bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related field; advanced degree (MS, PhD, PharmD, MD) preferred. + Minimum of 3 years of experience in medical writing with a focus on pharmacovigilance or regulatory affairs. + Strong knowledge of drug safety regulations and pharmacovigilance systems. + Proficiency with safety databases, literature databases (e.g., PubMed, Embase), and standard writing tools (e.g., Microsoft Word, Excel). + Excellent written and verbal communication skills with attention to detail. + Ability to manage multiple projects and work independently under tight deadlines.This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!\#INDBH We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Manufacturing & Utilities Middlesex County, NJ, US + Added - 12/12/2025 Apply for Job Opportunity for an experienced HVAC professional (multiple levels considered) to continue their career supporting downstream and upstream manufacturing operations. This role is with a global biopharma leader with a strong footprint in R&D, commercial manufacturing, and cutting-edge pharmaceutical production. 1st Shift Salary: 80k/yr. Location: Middlesex County, NJ The HVAC Operator will play a critical role in maintaining optimal environmental conditions across GMP biopharmaceutical facilities. This position supports HVAC, Building Management Systems (BMS), and essential process equipment to ensure uninterrupted downstream and upstream manufacturing operations. Ideal for candidates seeking stability, technical growth, and the ability to impact large-scale bioprocessing. **Key Responsibilities** + Operate, monitor, and maintain HVAC and BMS systems to ensure proper climate control, system reliability, and production support. + Troubleshoot, diagnose, and repair HVAC components including chillers, AHUs, VAV systems, and facility ventilation. + Perform routine inspections and preventive maintenance on process equipment such as bioreactors, fermenters, and related utilities. + Maintain detailed records including maintenance activities, system performance logs, and operational documentation. + Collaborate with facilities, engineering, and operations teams to implement system upgrades and continuous improvements. + Support equipment validation, commissioning, and qualification in alignment with GMP and regulatory standards. + Respond promptly to alarms and equipment emergencies to ensure uninterrupted production. + Adhere to all safety protocols and participate in ongoing safety training. + Provide guidance and mentorship to junior technicians and operations personnel as needed. **Qualifications** + High school diploma or equivalent; HVAC, mechanical systems, or technical certification preferred. + **Minimum 5 years of HVAC/BMS experience in a pharmaceutical, biotech, or regulated manufacturing environment.** + Strong proficiency in Building Management Systems operation and troubleshooting. + Solid understanding of HVAC fundamentals, mechanical systems, and bioprocess equipment support. + Working knowledge of GMP, FDA, and biopharma-regulated environments. + Strong analytical, diagnostic, and problem-solving skills. + Effective communication and teamwork abilities. + Ability to work flexible hours, including nights/weekends if required for operational needs. ** **_This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you**_** \#LI-DNP INDBH We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Quality Assurance Middlesex County, NJ, US + Added - 04/12/2025 Apply for Job Pay Rate Low: 30.00 | Pay Rate High: 40.00 **Raw Materials Compliance Specialist** We are seeking a Raw Materials QA Specialist for our client who has a global footprint in both R&D and manufacturing within the biopharma industry. The QA Specialist will play a key role in ensuring the quality, safety, and compliance of raw materials and related processes in support of biotechnology manufacturing operations. **Type:** Contract-to-hire **Shift:** M-F, 1st Shift **Location:** Middlesex County, NJ **Pay:** $30 - $40/hr **Key Responsibilities** + Review and approve raw material documentation (e.g., Certificates of Analysis, specifications, vendor documents) for accuracy and compliance. + Perform raw material release activities in accordance with established SOPs and GMP requirements. + Coordinate and/or review raw material sampling to ensure proper identification, handling, and chain of custody. + Review QC laboratory documentation and analytical data for accuracy, completeness, and compliance with applicable procedures and specifications. + Review and track stability reports, ensuring timely completion, accuracy, and adherence to protocols. + Support investigations, deviations, CAPAs, and change controls related to raw materials and QC data. + Collaborate cross-functionally with Quality Control, Supply Chain, and Manufacturing to ensure smooth flow of materials and documentation. + Participate in internal and external audits, as needed. + Identify and support opportunities for continuous improvement in quality systems and documentation processes. **Qualifications** + Bachelor's degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, or related field) required. + 2-5 years of experience in aseptic raw material sampling. + Strong knowledge of GMP regulations (21 CFR Part 210/211) and quality system principles. + Experience reviewing QC data, raw material documentation, and stability reports. + Detail-oriented with strong organizational and documentation skills. + Excellent communication and teamwork abilities. + Proficiency with Microsoft Office and familiarity with quality management systems (QMS) or LIMS preferred **.** _This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!_ _INDBH_ We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Science & Research Mercer County, NJ, US + Added - 21/08/2025 Apply for Job Our Client, a global leader in personal care and household products, is seeking a Lab Technician to join their growing team. This is a great opportunity to work with one of the world's fastest growing consumer packaged goods companies. **Type:** Contract **Pay:** $22/hr **Responsibilities:** + Prepare consumer product formulations + Measure pH, specific gravity and viscosity, perform stability tests, product performance evaluation, fragrance evaluation by test panels, record keeping and housekeeping. + Conduct all applicable testing relating to product care in the product group. **Requirements:** + BS In Chemistry or related science + Hands on laboratory experience preferred (can be from school) + Preference is for experience with wet chemistry (pH, viscosity, titrations, etc.) + Must have strong work ethic and attention to detail This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you! \#INDBH We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Manufacturing & Utilities Middlesex County, NJ, US + Added - 09/12/2025 Apply for Job Pay Rate Low: 33.00 | Pay Rate High: 40.00 The Water Systems Operator will be responsible for the operation, monitoring, and maintenance of purified water (PW) and Water for Injection (WFI) systems within a GMP-regulated biotechnology or biopharmaceutical manufacturing facility. This role ensures all water and clean steam systems operate reliably, efficiently, and in full regulatory compliance to support continuous manufacturing operations. The ideal candidate will have strong technical skills, mechanical aptitude, and attention to detail in maintaining high-purity utility systems. **Location:** Middlesex County, NJ **Pay Range:** $33-$40 per hour (based on experience) **Shifts:** 1st, 2nd, & 3rd shift options available - must have flexibility to rotate weekends Key Responsibilities + Operate, monitor, and maintain WFI, purified water, and clean steam systems, ensuring consistent quality and availability for manufacturing operations. + Perform routine sampling, testing, and data logging of water systems in compliance with GMP and USP requirements. + Conduct preventive and corrective maintenance on water system components, including RO units, EDI systems, heat exchangers, pumps, valves, filters, and distribution loops. + Monitor system performance trends, respond to alarms or deviations, and take corrective actions to prevent downtime. + Support validation, calibration, and change control activities related to water and utility systems. + Maintain accurate, compliant documentation in accordance with SOPs, GMP, and FDA regulations. + Collaborate cross-functionally with Facilities, Engineering, and Quality teams to investigate issues and implement improvements. + Participate in on-call rotations and weekend coverage to support 24/7 facility operations. Qualifications + Minimum Education: High School Diploma or equivalent required. + Experience: Minimum 2 years operating or maintaining WFI, purified water, or clean utility systems in a GMP-regulated biotech, biopharma, or pharmaceutical environment. + Strong understanding of water generation and distribution principles, including reverse osmosis (RO), electrodeionization (EDI), and distillation. + Working knowledge of GMP, USP, and FDA requirements governing clean utilities. + Ability to read and interpret P&IDs, system schematics, and technical manuals. + Strong mechanical aptitude, attention to detail, and proactive problem-solving skills. + Excellent communication and teamwork abilities. + Shift flexibility required - ability to work rotating weekends and participate in after-hours support as needed. This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you! \#LI-DNP INDBH We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Laboratory Middlesex County, NJ, US + Added - 11/12/2025 Apply for Job Pay Rate Low: 35.00 | Pay Rate High: 45.00 The Media Prep Technician will play a key role in supporting upstream biomanufacturing operations. This role focuses on the preparation and sterilization of media, buffers, and solutions in a GMP-compliant environment. Responsibilities include operating large-scale equipment (500L-2000L), maintaining accurate and complete batch records, and ensuring strict adherence to quality and safety standards. **Location:** Middlesex County, NJ **Employment Type:** Contract to Hire **Key Responsibilities:** + Prepare, sterilize, and handle media, buffers, and other solutions required for upstream biomanufacturing processes. + Operate and monitor large-scale equipment ranging from 500L to 2000L. + Maintain detailed and accurate batch records in compliance with GMP requirements. + Perform routine cleaning, maintenance, and calibration of equipment. + Adhere to safety protocols, cGMP guidelines, and company SOPs. + Collaborate with upstream manufacturing teams to ensure media quality and availability. **Qualifications:** + Bachelor's degree in Biology, Biotechnology, or a related field. + Minimum of 3 years' experience in a GMP biotechnology or biopharmaceutical setting. + Hands-on experience with large-scale media preparation, solution handling, and equipment operation. + Experience in equipment cleaning, sterilization, and calibration. + Strong attention to detail and ability to maintain accurate documentation. + Knowledge of GMP regulations and compliance standards. **Preferred Skills:** + Ability to work effectively in a fast-paced, team-oriented environment. + Strong problem-solving and organizational skills. + Familiarity with upstream biomanufacturing workflows and terminology. _This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!_ INDBH \#LI-DNP We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Engineering Mercer County, NJ, US + Added - 26/02/2025 Apply for Job Our Client, a global leader in personal care and household products, is seeking a Process Engineer to join their growing team. This is a great opportunity to work with one of the world's fastest growing consumer packaged goods companies. **Key Responsibilities** + Lead process development, including pilot plant design, operation, and data analysis. + Support projects by writing process trial documentation and reports. + Work cross functionally with R&D to develop and improve products + Conduct feasibility studies of product/process + Participate in process validation and cGMP implementation. + Test process changes, troubleshoot issues, and offer plant support. **Education & Experience** + B.S. or M.S. in Chemical, Materials, or similar + 2+ years of relevant experience. Pay: $38-42/hr This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you! We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Manufacturing Clinton , NJ, US + Added - 30/04/2025 Apply for Job Our Client, a Fortune 100 energy company who specializes in pioneering new research and pursuing new technologies to create more efficient forms of energy, is seeking a Chemical Technician to join their growing team. Pay: $25-28/hr 1st shift M-F **Summary:** + Maintaining the safety and security of the work area + Chemical handling requiring physical labor + Following detailed instructions to create lab and pilot scale lubricant blends + Preparing samples for evaluation and analysis + Maintaining supplies, files, and chemical inventory + Detailed data management + Performing safety inspections and general housekeeping duties **Qualifications:** + 2+ years of experience compounding, mixing, blending materials + Experience handling chemicals or other manufacturing material + Strong communication skills + Minimum of a HS Diploma or GED required This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you! We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Manufacturing & Utilities Middlesex County, NJ, US + Added - 02/12/2025 Apply for Job Pay Rate Low: 33.00 | Pay Rate High: 40.00 **Facilities & Equipment Maintenance Technician - Biotech / Pharmaceutical Manufacturing** Join our client's team to maintain critical facility systems and process equipment in a GMP-regulated biologics environment. You'll work hands-on with HVAC, chillers, boilers, and bioreactors, ensuring reliable operations and supporting life-changing biotech manufacturing. Bring your troubleshooting skills and proactive maintenance expertise to a global biopharma leader! **Type:** Contract-to-hire **Rate:** $33 - $40/hr **Location:** Middlesex County, NJ **Shift: 1st and 3rd** **Duties:** + Perform routine and emergency maintenance on facility systems, including HVAC, boilers, chillers, air compressors, and cold storage units (freezers, refrigerators, incubators). + Monitor and maintain building utilities and environmental control systems supporting GMP production areas. + Conduct preventive maintenance and calibration checks on bioreactors, shakers, centrifuges, pumps, and other lab or process equipment. + Troubleshoot equipment and system issues to minimize downtime and maintain continuous operations. + Support installation, qualification, and commissioning of new or upgraded equipment and utilities. + Maintain accurate documentation in accordance with GMP standards, SOPs, and company policies. + Collaborate cross-functionally with Manufacturing, Quality, and Engineering teams to ensure compliance and operational readiness. + Participate in after-hours or weekend on-call rotations to support 24/7 facility operations. **Qualifications:** + High School Diploma required. + Minimum 2+ years of experience in facilities or equipment maintenance within a **GMP-regulated biotech, biopharmaceutical, or pharmaceutical environment.** + Hands-on experience with HVAC systems, chillers, boilers, and cold storage equipment. + Strong working knowledge of bioreactors, shakers, and related laboratory/process systems. + Familiarity with GMP documentation, calibration, and validation practices. + Ability to read and interpret technical drawings, P&IDs, and equipment manuals. + Excellent troubleshooting, communication, and teamwork skills. _This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!_ INDBH We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Science & Research Middlesex County, NJ, US + Added - 24/01/2025 Apply for Job Our client who is a specialized CDMO within the pharmaceutical industry is looking for a seasoned Chemist to lead method development for various analytical methods. **Key Responsibilities:** + Develop, optimize, and validate HPLC methods for the analysis of raw materials, intermediates, and finished pharmaceutical products. + Troubleshoot and refine methods to ensure robustness and reproducibility. + Prepare technical reports and documentation in compliance with regulatory requirements. + Support QC studies and process development through method application. + Collaborate with other departments, including R&D and quality control, to ensure accurate and timely analysis. **Qualifications:** + Bachelor's degree in Chemistry, Pharmaceutical Sciences, or related field + Proven experience with HPLC and related analytical techniques in a pharmaceutical or laboratory setting. + Experience in HPLC method development + Strong knowledge of regulatory guidelines such as GMP + Excellent problem-solving and communication skills. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Quality Assurance Middlesex County, NJ, US + Added - 05/12/2025 Apply for Job Pay Rate Low: 30.00 | Pay Rate High: 40.00 **The QA Specialist will play a key role in ensuring the quality, safety, and compliance of raw materials and related processes in support of biotechnology manufacturing operations. This position is responsible for reviewing raw material documentation, coordinating and reviewing raw material sampling and release, verifying QC data, and supporting the review of stability reports to ensure adherence to internal procedures, regulatory guidelines, and cGMP standards.** **Key Responsibilities:** + Review and approve **raw material documentation** (e.g., Certificates of Analysis, specifications, vendor documents) for accuracy and compliance. + Perform **raw material release** activities in accordance with established SOPs and GMP requirements. + Coordinate and/or review **raw material sampling** to ensure proper identification, handling, and chain of custody. + Review **QC laboratory documentation and analytical data** for accuracy, completeness, and compliance with applicable procedures and specifications. + Review and track **stability reports** , ensuring timely completion, accuracy, and adherence to protocols. + Support investigations, deviations, CAPAs, and change controls related to raw materials and QC data. + Collaborate cross-functionally with Quality Control, Supply Chain, and Manufacturing to ensure smooth flow of materials and documentation. + Participate in internal and external audits, as needed. + Identify and support opportunities for continuous improvement in quality systems and documentation processes. **Qualifications:** + **Bachelor's degree** in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, or related field) required. + **2-5 years of experience** in Quality Assurance within the biotechnology, biopharmaceutical, or pharmaceutical industry. + Strong knowledge of **GMP regulations (21 CFR Part 210/211)** and quality system principles. + Experience reviewing QC data, raw material documentation, and stability reports. + Detail-oriented with strong organizational and documentation skills. + Excellent communication and teamwork abilities. + Proficiency with Microsoft Office and familiarity with quality management systems (QMS) or LIMS preferred. INDBH #LI-DNP We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Science & Research Middlesex County, NJ, US + Added - 11/12/2025 Apply for Job Pay Rate Low: 35 | Pay Rate High: 38 We are seeking an Analytical Scientist to join a reputable pharmaceutical manufacturing company to conduct routine and non-routine analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples. _** No Relocation or C2C available **_ **Type:** Contract **Pay:** Up to $38/hr **Location:** Middlesex County, NJ **RESPONSIBILITIES:** + Conduct and document chemical analyses for raw materials, in-process goods, and finished products. + Design, validate, and resolve issues with analytical methods, including HPLC for cleaning verification. + Collect and analyze equipment cleaning validation samples. + Prepare Certificates of Analysis, analytical reports, and maintain lab documentation. + Peer-review records and support OOS or OOT investigations as per SOPs. + Ensure compliance with SOPs, cGMPs, and regulatory requirements. + Assist with environmental monitoring and other tasks as assigned. **QUALIFICATIONS:** + Bachelor's in chemistry-related discipline with 2+ years of analytical lab experience. + Strong technical proficiency with HPLC/UPLC, GC, UV, FTIR, Karl Fischer, and particle size analysis. + Hands-on background in method transfer and method verification; method validation experience is a strong plus (HPLC). + Knowledge of cGMPs, pharmacopeia (USP, EP), and regulatory standards (21 CFR Part 210/211/820, ISO). _This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!_ _INDBH_ _\#LI-DNP_ We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Manufacturing Middlesex County, NJ, US + Added - 30/01/2025 Apply for Job Opportunity for an experienced scientist to continue their career in downstream/upstream manufacturing. This role will be with our client who has a global footprint in both R&D and manufacturing within the biopharma industry. **Primary Responsibilities:** + Perform upstream processing in a cGMP environment + Collaborate with a team of manufacturing associates and engineers to execute upstream batches. + Perform cell culture and bioreactor operations (single-use fed-batch bioreactors) at various scales. + Conduct harvest clarification processes using centrifuges and depth filters at multiple scales 2,000LT+ preffered! + Create and maintain equipment specifications and enhance manufacturing procedures. + Follow GMP protocols within the production area **Qualifications:** + Bachelor's degree in Biology, Biochemistry, or other life science + 2+ years in upstream biomanufacturing This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you! We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Engineering Somerset County, NJ, US + Added - 19/02/2025 Apply for Job Our client who is a global, Fortune 100 Medical Device company is seeking a Process Engineer to join their team in Somerset Count, NJ. **:** We are seeking a Process Engineer with 1+ years of experience in the medical device industry. The successful candidate will be responsible for supporting the design, optimization, and scaling of manufacturing processes for medical devices. Key responsibilities include analyzing production workflows, identifying process improvements, ensuring product quality standards, and collaborating with cross-functional teams to troubleshoot and resolve technical challenges. **Key Responsibilities:** + Assist in process development, validation, and optimization for medical and surgical products + Ensure compliance with quality and regulatory standards + Collaborate with R&D, manufacturing, and quality assurance teams to improve process efficiency. + Support continuous improvement initiatives to enhance product performance and reduce waste. + Contribute to materials selection and work closely with vendors to source appropriate materials for medical device production. **Qualifications:** + Bachelor's degree in Engineering, advanced degree preferred (Master or PhD) + 1+ years of experience in the medical device industry, focused on process engineering + Strong knowledge of manufacturing processes including Process Capability, Process Validation, Design of Experiments, and Development of Equipment Trials + Experience with material selection and vendor collaboration in a medical device context. + Excellent problem-solving, communication, and collaboration skills. Pay Rate: $45-50/hr This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you! We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Manufacturing & Utilities Middlesex County, NJ, US + Added - 12/12/2025 Apply for Job Pay Rate Low: 70000 | Pay Rate High: 83000 Join our client's team as a Senior HVAC Operator supporting critical facility systems in a GMP-regulated biotech environment. In this role, you will operate, monitor, and maintain HVAC and BMS systems to ensure precise climate control and building performance. You'll troubleshoot and repair chillers, air handlers, ventilation systems, and other HVAC components while also performing routine inspections and preventive maintenance on process equipment such as bioreactors and fermenters. **Type:** Direct Hire **Location:** Middlesex County, NJ **Pay:** $70,000 - $83,000 **Key Responsibilities:** + Operate, monitor, and maintain HVAC and BMS systems to ensure optimal climate control and building performance. + Troubleshoot, diagnose, and repair HVAC components, including chillers, air handling units, and ventilation systems. + Perform routine inspections and preventive maintenance on process equipment such as bioreactors, fermenters, and support systems. + Maintain and update records of maintenance activities, system performance logs, and operational procedures. + Collaborate with the facilities and engineering teams to implement upgrades and improvements to HVAC, BMS, and process equipment. + Support validation and qualification efforts of new and existing equipment in compliance with GMP and regulatory requirements. + Respond to equipment alarms and emergencies, providing timely and effective solutions to maintain uninterrupted operations. + Ensure compliance with safety standards and participate in safety training and protocols. + Provide technical guidance and training to junior technicians and operators as needed. **Qualifications:** + High school diploma or equivalent; technical degree or certification in HVAC, mechanical systems, or a related field preferred. + Minimum 5 years of experience working with HVAC, BMS, and process equipment in a biotech or pharmaceutical environment. + Proficiency in operating and troubleshooting Building Management Systems + Strong understanding of HVAC principles, process equipment operations, and related mechanical systems. + Knowledge of GMP, FDA, and other regulatory standards relevant to biotech facilities. + Strong analytical and problem-solving skills. + Excellent communication and teamwork abilities. + Ability to work flexible hours, including nights and weekends, as needed. INDBH We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.