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Pharmaceutics International jobs - 51 jobs

  • Equipment Validation Associate

    Pharmaceutics International Inc. 4.5company rating

    Pharmaceutics International Inc. job in Maryland

    Responsible for assuring the highest quality level of the company processes and products maintaining monitoring of qualifications and validation of facilities, instruments, and equipment, performing, and supporting cleaning and process validation, ensuring proper performance as per company procedures, and providing excellent service to guarantee customer satisfaction. Support validation activities for aseptic and non-aseptic production environment. Focus of position : Calibration/Metrology/Equipment Qualification Manages, coordinates, performs, and reports all activities related to the calibration of equipment used at Pharmaceutics International Incorporated. Support other validation activities such as equipment commissioning, qualifications, and process validations. Responsibilities: The essential functions of the position include, but are not limited to: Performs calibrations for all equipment and instrumentation involved in, but not limited to, manufacturing processes at Pharmaceutics International Incorporated. Understands equipment/instrument specifications, calibrations, out of specifications, tolerance limits for different instruments Creates documentation that accurately describes the procedures required to effectively calibrate equipment. Provides initial Standard Operating Procedure (SOP) training to all responsible personnel. Assists in the troubleshooting of equipment and contacts maintenance for all repairs when necessary. Review equipment/system/utility qualification (IQ/OQ/PQ), calibrations, engineering, process, packaging, and cleaning validations prepared by other team members. Assures that assigned obligations are conducted in accordance with cGMPs, or any other company approved documentation. Interacts with peers and vendors to ensure project timelines are achieved and offering satisfactory alternatives when necessary. Execute protocols and related activities associated with cleaning and process validation, transferring new products/ processes from R&D to manufacturing, and executing process/documentation improvements. Perform statistical analysis for process monitoring. Initiate and investigate protocol deviations, events, exceptions, and coordinate follow up with QA. Initiate, follow-up, close out and implementation of corrective and preventive actions. Co-ordinate activities related to risk management and preparation of quality risk management and risk assessments related to products and processes. Coordinate with cross functional teams for internal and external audits. Provide all required documentation. Interacts with other departments to ensure project activities are performed in a timely manner. Scans, archives, and organizes all validation documentation. Continues to increase knowledge of latest process technologies within the pharmaceutical industry. Additional functions and responsibilities as needed or assigned. Essential Specialized Knowledge and/or Skills to Perform Job: Ability to read, write and speak English fluently. Ability to communicate effectively to team members on a routine basis Knowledge of cGMPs, manufacturing procedures of Pii's product line and company policies/regulations; knowledge of manufacturing operations and validation guidelines - SOPs, FDA, OSHA, DEA and MSDS requirements. Qualifications: Education/Experience: Bachelor's degree, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities. Associate with a minimum of 2 years experience within the pharmaceutical, cosmetic, or food industry, specifically with Metrology/Calibrations. Competency: To perform the job successfully, an individual should demonstrate the following competencies: Analytical - Working knowledge of cGMPs and internal SOPs; identifies, collects and organizes data from multiple sources; ability to handle several projects simultaneously; demonstrates attention to detail; identifies and resolves problems in a timely manner. Customer Service - Responds to requests for service and assistance with professionalism, courtesy and confidence. Technical Skills - Ability to make timely decisions, root cause analysis and ability to define effective corrective and preventative action. Interpersonal Skills - Interacts with management and non-management employees across all department within Pii and outside clients. Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarifications. Team Work - Balances team and individual responsibilities; able to build morale and group commitments to goals and objectives; focuses on solving conflict, not blaming; maintains confidentiality; listens to others without interrupting; remains open to others ideas and not afraid to try new ideas. Diversity - Shows respect and sensitivity for personal and cultural differences. Values multiple viewpoints and is sensitive to factors (race, gender, age, culture, and religion) that may affect behavior and feelings. Ethics - Works with integrity and ethically; maintains confidentiality Professionalism - Treats others with respect and consideration. Attendance/Punctuality - Is consistently at work and on time. Dependability - Follows instructions, responds to management direction; takes responsibility for own actions. Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality. Consistently checks all documents for errors and constantly strives for right the first time mentality. Safety and Security - Observes safety and security procedures; responsible for meeting department safety objectives and to develop on-going safe operating procedures consistent with the job requirements. Language Ability - Ability to read, write and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Math Ability - Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals and percents. Reasoning Ability - Ability to solve practical problems and deal with a variety of variables in situations where only limited standardization exists. Computer Skills - Basic computer skills, i.e., Outlook, Microsoft Word, Excel and PowerPoint Physical Demands Specific vision abilities required include peripheral vision, depth perception, and ability to adjust focus. Ability to travel between and within facilities to visit staff, operations, and projects, as needed. Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary). Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary). Work Environment and Physical Demands: The work environment characteristics and physical demands described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Employees are supplied personal protection equipment (PPE), safety shoes, glasses and hearing protection whenever necessary for critical processes within manufacturing. While performing the duties of this job, the employee is frequently required to stand; walk; use hands to finger; handle; or feel; reach with hands and arms, climb or balance, stoop, kneel, crouch, or crawl, talk or hear and taste or smell. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required include peripheral vision, depth perception, color vision and ability to adjust focus.
    $41k-80k yearly est. Auto-Apply 60d+ ago
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  • 2nd Shift Packaging Technician

    Pharmaceutics International Inc. 4.5company rating

    Pharmaceutics International Inc. job in Huntingtown, MD

    As a Pharmaceutical Packaging Technician, you will be responsible for packaging a range of pharmaceutical products for clinical and commercial use. You will operate, set up, maintain, and clean equipment while following established standardized procedures. Additionally, you will thoroughly document production efforts to ensure compliance with regulatory guidelines. Responsibilities: Performs assigned duties as outlined in the SOPs for packaging of pharmaceutical products according to written instructions from Packaging Labeling records with assistance from a trained packaging technician. Under the guidance of a junior or senior packaging technician, assists in the setup, operation, disassembly, and monitoring of packaging equipment per specifications or packaging instructions for solid, semi-solid, and liquid dosage forms. Assists in performing cleaning procedures on packaging equipment and areas using written procedures, cleaning solutions, and materials under the guidance of a trained packaging technician. Notifies Management of any observed cGMP violations encountered during the performance of job duties and responsibilities. Follows all safety procedures within the cGMP packaging areas and reports all discrepancies to management immediately. Ensures the work area is neat, clean, and orderly by end of the shift. Enhance organizational reputation by striving to meet and exceed performance expectations. Work cooperatively with Quality Assurance and other internal departments to ensure appropriate coordination of manufacturing activities. Maintain job knowledge and training current to ensure compliance in all activities. To identify, investigate, participate in, and take ownership of compliance issues and deviations when discovered. Support the identification and implementation of corrective and preventive actions (CAPAs). Perform other duties as assigned. Qualifications: HS/ GED required with a minimum of 18 months experience as a Junior Packaging Technician within Pii or a minimum of 3 years in the pharmaceutical, cosmetic, or food industry, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities. Ability to add, subtract, multiply and divide all in units of measure, using whole numbers, common fractions and decimals, and percentages. Must have the ability to learn the metric system, weight, and volume measurements. Mechanically inclined; reads and interprets equipment and process documents; follows operating instructions. Exhibits objectivity and openness to others' views. Takes personal accountability for contributions to the team and organizational results. Demonstrated accuracy and thoroughness; looks for ways to improve and promote quality. Consistently checks all documents for errors and constantly strives for right the first time mentality. Demonstrate the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates. Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision. Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required. Must be able to comprehend and follow all applicable SOPs. Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise. Demonstrate ability to acquire the appropriate knowledge from resources on the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products. Good understanding of cGMPs, industry, and regulatory standards and guidelines. Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc. Demonstrate the ability to portray the appropriate level of integrity and professionalism. Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats. Demonstrate the ability to complete tasks accurately and according to established and shifting timelines. Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions. Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment. Results-oriented and efficient. Creative and open-minded who fosters an environment in which sharing of ideas is encouraged. Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally). Demonstrate the ability to work well in a cross-functional team environment. Must communicate fluently in English and have legible handwriting. Physical Demands: Ability to travel between and within facilities to visit staff, operations, and projects, as needed. Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary). Ability to lift up to 40 pounds on occasion. Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).
    $33k-43k yearly est. Auto-Apply 60d+ ago
  • Senior Materials Planner

    Catalent Pharma Solutions 4.4company rating

    Severn, MD job

    + 100% on-site Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. The **Senior Materials Planner** ("Sr. Materials Planner") is part of a team responsible for managing the supply of assigned materials to support pre-clinical, early to late phase clinical, and commercial manufacturing requirements while maintaining targeted inventories. The objective of the Sr. Materials Planner is to ensure that materials are available and released by Quality at the right time, in the right location and at the right quantity for scheduled activities. The Sr. Materials Planner will also assist in improving the material planning function through implementation of planning best practices and full utilization of the JDE system. This position will closely interface with the Ready-to-Execute team, Production Scheduling, Material Control, Buyers, Costing, Manufacturing, Quality Raw Materials, MS&T, and Project Management. The Sr. Materials Planner will report to the Director, Supply Chain Planning. **The role:** + Material Requirement Planning (MRP) for multiple manufacturing and warehousing sites, clients and products. + Tracking and reporting material readiness daily to Ready to Execute and as requested by internal and external clients. + Regular review of planning parameters impacting MRP such as safety stock, reorder point and Kanban or Min/Max levels. + Expediting and problem-solving supply issues with Buyers, Material Control, Manufacturing and Quality Raw Materials. + Driving maximum utilization of the ERP system (JDE) for all MRP functions and inventory control. + Managing input of Work Orders, attachment of Bills of Material and Routings and creation of Purchase Requisitions. + Contributing to the lifecycle management process to optimize inventory, mitigate material expiration and reduce scrap. + Participating in continuous improvement projects. **The candidate:** + Bachelor's degree in Supply Chain or similar area. + 5-6 years material planning or directly related Supply Chain experience. + Experience in cGMP environment preferred. Pharma/Biotech/CMO highly desirable. + Proficiency with ERP / MRP systems. JDE desirable. + Experience in developing and implementing processes, procedures, and systems preferred. + Intermediate/Advanced knowledge of Microsoft Office products. + Lean/Six Sigma experience desirable. + Supply Chain Certification such as CPIM is desirable. The anticipated salary range for this position in Maryland is $100,000-$118,000 plus an annual bonus target. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. **Why you should join Catalent:** + Competitive medical benefits and 401K + 152 hours PTO + 8 Paid Holidays + Dynamic, fast-paced work environment + Opportunity to work on Continuous Improvement Processes **Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers (*********************************** to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .
    $100k-118k yearly 14d ago
  • VP, Commercial Operations

    Catalent Pharma Solutions 4.4company rating

    Severn, MD job

    The position is responsible for managing a team that supports the overall Catalent business by providing commercial support of existing customer relationships, and on-site support for new customers and business development opportunities. Working with the site's GM, Supply Chain, Product Development, Operations, Project Management, CGT Business Development and other cross functional teams, this position ensures that customer programs effectively transition from signed opportunity to development/tech transfer programs to commercial launch and routine production through the products life cycle. The position is also responsible for contracting and contract support and will ensure ongoing customer programs are managed according to contracted terms. The person in this position will be a member of the Site Leadership Team for the site(s) that the position is responsible for. **The Role:** + Manage a Commercial Operations team who act as key relationship managers for certain customers (existing and new) at the relevant site(s) to ensure a superior level of communication occurs between the parties. Supports other sites as needed. + Assist the proposal lead function and provide appropriate review of scope /pricing of new business proposals for development, tech transfer proposals and pipeline proposals. + Manage the process of determining a commercial price for all new products along those products that have relevant changes (gathering COGS, getting alignment on pricing, margin enhancement, maintenance of COGS for products and pricing letters as applicable). + Act as key site resource for development of commercial pricing; works with site finance to understand profitability and works with BD on pricing strategy. + Provide SME support to BD and Contract Negotiation teams on strategy/negotiation of proposals, development agreements and commercial supply agreements. + Accountable for management of all client contracts including commercial supply agreements, Development and Licensing Agreements, term sheets and other Client contracts to ensure capture of relevant provisions (e.g., fees, price increases, KPIs, forecasts, renewals). + Work with site leadership, Finance and BD to manage Accounts Receivable at the site; specifically engage with clients that are habitually late payers. + Manage client disputes for AR issues, batch issues and/or API reimbursement requests. + Serve as pricing leader for site and appropriately manage and execute against identified value pricing opportunities. Work with BD and site team to implement value pricing practices and processes. + Work as an integral member of the site, working closely with site GM, MSTAT, supply chain directors, and BD team to identify and pursue current fiscal year revenue opportunities with existing customers. Participate in budgets and forecasts related to customer revenue through participation in the site S&OP process and other relevant meetings/processes as needed. + Provide input for metrics tracking, reporting, budgeting and forecasting as needed, specifically related to funnel forecasting and pipeline management. + Continually evaluate and adapt new business and customer processes to create greater efficiency and effectiveness in pursuing new business and managing existing customers. + Responsible for Client Experience and the organization of new Client visits. + Support site GM in preparing yearly strategic plan and site budget. + Responsible for leading Revenue Leakage at site- training, implementation, follow up and tracking. **The Candidate:** + Bachelor's degree in science, business administration or other related field, Master's of business administration preferred + 10+ years of relevant experience in pharmaceutical or medical device manufacturing, quality or regulatory, general business management, technical project management and analysis. + 10+ years of relevant CDMO experience in pharmaceutical, experience in quality, technical project management, business management and/or business development + Relevant industry knowledge of drug product development, analytical research and development, project scale-up, product manufacturing, quality, validations, and regulatory + Analytical, financial skills, business acumen + Knowledge of ERP/MRP/CRM systems + Superior customer services skills and professional demeanor + Prior direct contract negotiation experience preferred **Physical Demands:** + Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. + Occasional stooping, kneeling, crouching, bending, carrying, grasping. The anticipated salary range for this position in Harmans, MD is $268,750 - $300,570 plus variable incentive compensation. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. **Work Environment:** This is an on-site job, at the Maryland Harmans location. **Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers (*********************************** to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (*************************************************************************************************************************** .
    $147k-217k yearly est. 60d+ ago
  • Technical Operations Specialist

    Mallinckrodt Pharmaceuticals 4.8company rating

    Berwyn Heights, MD job

    Job Title Technical Operations Specialist Requisition JR000015586 Technical Operations Specialist (Open) Additional Locations Reporting to Senior Manager, Technical Operations and based at College Park Manufacturing Facility (CPMF). Technical Operations Specialist will be responsible to perform and oversee multi-step process development, standardisation, and evaluation with an aim of establishing laboratory scale manufacturing modules to solve complex issues related to materials and process related changes. Working within the Technical Operations team, Technical operations specialist will also support the production activities ongoing in the existing manufacturing facility and will have considerable development laboratory focus for replication of the process at small scale. The Process Scientist will collaborate closely with other functions, including Operations, Quality (QA/QC), regulatory and other internal and external stakeholders. Job Description * Essential Functions * Work collaboratively in a cross-functional environment, partnering with teams from Operations, Quality, Engineering and Regulatory to ensure timely project execution and support commercial products. * Develop and maintain laboratory scale manufacturing models to attain a deeper understanding of the process and implement process control strategy in the commercial manufacturing environment. * Utilize all chemistry and laboratory tools and techniques (i.e. FTIR, NMR, UPLC/MS, Lyophilisation, Autoclave, extraction and purification etc.) to develop, assess and improve the manufacturing process and pathways. * Carry out feasibility study of the Process, Process Optimization, Lab Validations, Technology Transfer to plant and identify and evaluate the process parameters * Analyze experimental data to drive experimental plans. * Assist in the design, planning and execution of multi-step experimental studies guided by risk assessment to deliver safe, efficient, robust and scalable manufacturing processes. * Investigate optimization and scale-up of reaction and manufacturing unit operations. * Collaborate within project teams by working closely with analytical chemists, process engineers, pilot plant experts and project managers within the organization. * Communicate scientific results in a clear, concise, and accurate manner via electronic laboratory notebook documentation, development reports, project discussions and presentations. * Draft and review technical reports, external publications and patent applications. * May include management of outsourced laboratory activities: generating scope of work, supervising activities at CMOs, validating reports for outsourced activities. * Serves as Person in Plant for manufacturing campaigns as required. * Leads Tech Transfer projects between CMOs and internal stakeholders. * Authors or provides technical review of project documents, validation protocols, batch records, etc. * Act as SME for new material introductions and raw material/component replacement projects Department specific functions * Provide oversight of interns or contractors in the development lab as needed. * Support the generation of safety risk assessments and the implementation of site EHS policies. * Always ensure adherence to Safety guidelines and ensure immediate escalation and closure of safety risks. * Provide out-of-hours support during projects as required (infrequent, night hours may be required). * Participate in ad-hoc projects, goals and objectives as they arise. * Maintains detailed laboratory notebooks and ensures timely review and witnessing. * Maintains an awareness of literature appropriate to projects. * Maintains an awareness of global regulatory guidelines and applies those to product development strategy. Minimum Requirements Education / Experience / Skills: Education: * PhD in Chemistry, Biology, Engineering or related science. * MS in Chemistry, Biology, Engineering or related science. * BA or BS in Chemistry, Biology, Engineering or related science. Experience: * Science / Engineering degree required; analytical background preferred. * 3 - 5 years' experience in a biomanufacturing process related environment. * Have good knowledge of chemistry and laboratory tools and techniques (i.e. FTIR, NMR, UPLC/MS, Lyophilisation, Autoclave, extraction and purification etc.) * Ability to work independently and to adapt to fluid situations. * Fluency in English required * Proven ability to work in a team. * Excellent communication skills, demonstrated leadership experience and technical expertise in Scientific * Laboratory settings * Computer fluency competence in MS Office Suites. * Ability to maintain confidential and sensitive information is required. * Must be flexible and adaptable to accommodate changing challenges of role. Competencies Required Skills/Competencies: Needs to possess excellent oral and written communication skills. Advanced knowledge of laboratory procedures is necessary. Individual must demonstrate advanced problem-solving skills and technical competency. Must demonstrate the ability to work effectively in a team environment. Preferred Skills/Qualifications: Cross-functional knowledge of process chemistry and biomanufacturing is desired. Incorporation of laboratory automation technologies to enhance departmental efficiency is expected. Chemical Design for Six Sigma knowledge is a plus. Organizational Relationship/Scope Position directly reports to the Senior Manager, Technical Operations. Working closely with the key stakeholders, including: * Quality * Internal/External Manufacturing Operations * Regulatory Working Conditions This position involves normal office conditions with regular exposure to development laboratory operations. Occasional travel may be required for engagement with external laboratories and collaborators. The role is based at College Park manufacturing facility in Dublin. Extended or out-of-hours work may be required on occasion to support lab work or projects to meet the business needs. Disclaimer The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
    $101k-126k yearly est. Auto-Apply 1d ago
  • Sr. Hazardous Location Safety Engineer

    Eurofins Scientific 4.4company rating

    Baltimore, MD job

    Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2024, Eurofins generated total revenues of EUR € 6,515 billion, and has been among the best performing stocks in Europe over the past 20 years. Eurofins are a global leader in E&E testing, inspection and certification services. With a network of over 900 laboratories in 62 countries and over 62,000 dedicated employees, Eurofins is one of the international leaders of the testing industry. Eurofins E&E is an international network of laboratories offering expert and unbiased product safety and approvals services for electrical and electronics products. With accredited laboratories strategically located close to European, American and Asian production hubs, our comprehensive portfolio is available to both industrial and retail clients through a single point of contact. At our labs, over 450 million tests are performed each year to a portfolio of over 200,000 analytical methods. Job Description This is both a technical and client-facing role that would suit someone who is currently working for a manufacturer of process or industrial equipment in a product design capacity or working for a certification body or test laboratory; and who is enthusiastic, pragmatic, and thorough and who enjoys being part of a small, growing team. Experience is preferred at this stage, but we are also willing to discuss other roles and opportunities with newly qualified candidates. Senior roles may include responsibility for review of draft reports and mentoring trainee certification engineers. Sr. Hazardous Location Safety Engineer responsibilities include, but are not limited to, the following: * Assessment of products designed to national, regional and international standards. * Preparation of technical reports and certificates. * Preparation of test plans and working with the test engineer/technician to conduct tests correctly and safely. * Occasional conducting of tests either in the Eurofins labs or at customer sites. * Lead technical discussions with customers, resolve complex compliance issues, and provide authoritative interpretations of standards. * 40% travel domestically or internationally. * Preparation of quotations in partnership with the sales team. * Review of draft reports and mentoring/train trainee engineers. Employee standards * Support department objectives and company goals * Sustain a positive, enthusiastic and professional attitude and appearance at all times * Adhere to manager directives * Be punctual and arrive to work prepared for the day ahead * Perform all duties in a timely, accurate, honest and professional manner * Be respectful of others * Ability to follow procedures but also suggest improvements when noticed * Health and safety requirements to be at the forefront of your work Qualifications Basic Minimum Educational Requirements: * A bachelor's degree in engineering (Electrical or Mechanical preferred) or a related technical field. Basic Qualifications: * Minimum 5 years of relevant experience in hazardous location safety codes, standards, and regulations (e.g., OSHA, EPA, ATEX, IECEx, NFPA). Advanced knowledge of North American and international hazardous location requirements, including Class/Division and Zone systems. * Experience in electrical and mechanical testing to UL/CSA/IEC/EN 60079 series standards, UL 1203, UL 121201. REQUIRED * Strong understanding of product certification processes, accreditation requirements, and quality systems (ISO/IEC 17025, ISO/IEC 17065). * Familiarity with risk assessments, protection concepts, and ignition hazard evaluations for industrial equipment. * Familiarity with assessing to machinery directive. * Ability to evaluate/test to ordinary location safety standards UL/CSA/IEC/EN 62368-1, 61010-1, 60355-1, UL 508A, etc, preferred * Strong organizational skills with the ability to manage multiple complex projects independently. * Comfortable with 40% travel domestically and internationally * Authorization to work in the United States indefinitely without restriction or sponsorship. Additional Information Position is full-time working Monday - Friday 9:00am - 5:00pm. Candidates currently living within a commutable distance of Baltimore, MD are encouraged to apply. * Excellent full-time benefits including comprehensive medical coverage, dental, and vision options * Life and disability insurance * 401(k) with company match * Paid vacation and holidays Eurofins USA Clinical Diagnostics is a Disabled and Veteran Equal Employment Opportunity employer.
    $69k-99k yearly est. 8d ago
  • Supervisor, Facilities

    Catalent Pharma Solutions, Inc. 4.4company rating

    Severn, MD job

    Facilities Supervisor * Shift: Night Shift 6pm-6am * 100% on-site Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. The Facilities Supervisor is a key member of the Facilities & Engineering team and is responsible for supervising and executing preventive maintenance, repairs, and installations related to building utilities, HVAC, control systems, water and steam systems, and process equipment. This role oversees the day-to-day activities of the maintenance team, as well as contractors. The role: * Supervise a team of Facilities Mechanics across multiple shifts. * Operate and maintain utility systems including HVAC, clean steam generators, chillers, USP/DI water skids, plant steam boilers, air compressors, house vacuum, and refrigeration systems. * Troubleshoot mechanical and electrical systems across the facility. * Develop and maintain calibration and preventive maintenance programs for facility systems and equipment (manufacturing/laboratory). * Generate operational protocols and SOPs/records for utility systems. * Ensure functionality and monitoring of the Building Automation System (BAS). * Coordinate preventive maintenance and calibration activities with internal staff and external contractors. * Maintain accurate equipment logbooks and maintenance records. * Perform other duties as assigned. The candidate: * High School Diploma or equivalent required; bachelor's degree preferred. * Minimum of 5 years of relevant work experience in a GMP maintenance/engineering environment. * At least 3 years of supervisory or leadership experience. * Proficiency in control and automation systems operations. * Strong mechanical and electrical troubleshooting skills. * Experience with calibration and preventive maintenance procedures. * Understanding of GMP and regulatory compliance in a manufacturing setting. * Experience in automation and controls operations preferred. * Class III Stationary Engineer's License preferred. The anticipated salary range for this position in Maryland is $90,000-$115,000 plus an annual bonus target. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. Why you should join Catalent: * Competitive medical benefits and 401K * 152 hours PTO + 8 Paid Holidays * Dynamic, fast-paced work environment * Opportunity to work on Continuous Improvement Processes Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.
    $90k-115k yearly Auto-Apply 4d ago
  • Medical Science Liaison - Cutaneous Oncology - Los Angeles, CA

    Sun Pharmaceutical Industries 4.6company rating

    California, MD job

    Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over $ 4.5 billion US Dollars. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe including the United States. Sunology is a combination of Sun Values and Ideology and is the way of life at Sun Pharma. Sunology is Humility.Integrity.Passion.Innovation . It represents our promise to all stakeholders including patients, physicians, and employees. The MSL will primarily identify and engage with a targeted group of national and regional thought leaders/healthcare professionals (HCPs) as well as payers and managed care accounts, providing the consistent delivery of educational and compliant scientific information in support of Oncology products. The MSLs will engage with HCPs, NPs, & PAs who are in clinical practice caring for their patients. They will be trained to respond to complex inquiries in a scientific, fair-balanced, compliant manner serving as a critical field medical resource to these HCPs and also, internal SUN sales and managed markets constituents. Duties and Responsibilities: * Interact with healthcare providers and thought leaders to communicate and advance the scientific platform as aligned with SUN's corporate goals and objectives. * Communicate complex scientific information and research concepts to HCPs * Provide clinical and economic value information to payers and formulary decision makers * Identify and train members of SUN's speakers' bureau and ensure they are updated on new data * Respond to requests for investigator sponsored research (ISS) proposals and transit them into Sun and present the research to Sun for review. They will become the point of contact with the HCPs if ISS research is accepted and funded by Sun * Support SUN sponsored research * Provide feedback based on field interactions with healthcare providers and Thought Leaders to SUN stakeholders * Respond to scientific inquires consistent with the MSL compliance standards, * Foster scientific relationships between SUN and Fellows in training * Lead and/or participate on committees or project teams that support MSL strategies and tactics as delegated by MSL leadership * Seek out opportunities to support the MSL value proposition, achieve results and set an example for others to follow by consistently demonstrating SUN values and leadership attributes * Must have the ability to gain customer feedback, uncover business opportunities for SUN and pair customer's unmet needs with available internal resources. * Must be a strong team player who can effectively interface with SUN clinical and commercial personnel, as well as aide in training of SUN staff. * Demonstrate tact and professionalism when communicating and interacting with others * Comply with all applicable SUN Health Care Compliance SOPs and US regulations Qualifications: * Doctorate / Terminal degree required (eg, PharmD, MD, DO, DNP or PhD) * Oncology background strongly preferred * 1-3 years of clinical, research and/or field medical experience preferred * Thorough grasp of the pharmaceutical industry, FDA requirements and PhRMA code * Strong interpersonal, organizational, team, written and verbal communication skills * Strong presentation and education skills; ability to communicate clinical and non-clinical technical information effectively * Demonstrated project management ability * Travel up to 60-70% * Proficiency in Microsoft Office suite applications * Valid driver's license The presently-anticipated base compensation pay range for this position is $152,500 to $186,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time. Disclaimer The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s). We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law. Notice to Agency and Search Firm Representatives: Sun Pharmaceuticals Industries, Inc. (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
    $152.5k-186.5k yearly 60d+ ago
  • Electrical Laboratory Technician

    Eurofins Us Network 4.4company rating

    Baltimore, MD job

    Baltimore, MD, USA Full-time ** Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2024, Eurofins generated total revenues of EUR 6,515 billion, and has been among the best performing stocks in Europe over the past 20 years. Eurofins are a global leader in E&E testing, inspection and certification services. With a network of over 900 laboratories in 62 countries and over 62,000 dedicated employees, Eurofins is one of the international leaders of the testing industry. Eurofins E&E is an international network of laboratories offering expert and unbiased product safety and approvals services for electrical and electronics products. With accredited laboratories strategically located close to European, American and Asian production hubs, our comprehensive portfolio is available to both industrial and retail clients through a single point of contact. At our labs, over 450 million tests are performed each year to a portfolio of over 200,000 analytical methods. **Job Description** This is both a technical and client-facing role that would suit someone who is currently working for a manufacturer of process or industrial equipment in a product design capacity or working for a certification body or test laboratory; and who is enthusiastic, pragmatic, and thorough and who enjoys being part of a small, growing team. Experience is preferred at this stage, but we are also willing to discuss other roles and opportunities with newly qualified candidates. **Electrical Laboratory Technician responsibilities include, but are not limited to, the following** **:** + Assist in performing product safety tests and accurately document results. + Serve as custodian for all laboratory test equipment, ensuring proper handling, storage, and maintenance. + Perform routine quality checks and functional verification of power supplies and other key test instruments. + Maintain a clean, organized, and safe laboratory environment in compliance with company procedures and safety standards. + Support internal and external audits related to ISO/IEC 17025 and quality system requirements. + Occasional travel may be required in exceptional circumstances. **Employee standards** + Support department objectives and company goals + Sustain a positive, enthusiastic and professional attitude and appearance at all times + Adhere to manager directives + Be punctual and arrive to work prepared for the day ahead + Perform all duties in a timely, accurate, honest and professional manner + Be respectful of others + Ability to follow procedures but also suggest improvements when noticed + Health and safety requirements to be at the forefront of your work **Qualifications** **Basic Minimum Qualifications** **:** + **Minimum 2 years Electronic Technology or related associate degree.** + **Experience working in an electrical test lab, manufacturing environment, or certification/testing organization.** + **Experience in the electrical, electronic, or TIC industry.** + **Experience using common electrical test equipment (power supplies, DMMs, etc.)** + Ability to use MS Office tools. + Hands-on experience with common electrical test equipment (e.g., power supplies, multimeters, oscilloscopes, hipot testers). + Familiarity with calibration practices or ISO/IEC 17025 environments. + Forklift or material handling experience. + Authorization to work in the United States indefinitely without restriction or sponsorship. **The Ideal Candidate Possesses the Following:** + Self-motivated/self-starter with the ability to work independently in an efficient manner. + Strong attention to details. + Strong writing, documentation, and speaking skills. + Ability to learn new skills and assume new responsibilities. + Ability to work cooperatively in a team environment. + Ability to read basic technical documentation and follow procedures. + Strong organization and troubleshooting skills. **Additional Information** Position is **full-time** . Candidates currently living within a commutable distance of Baltimore, MD are encouraged to apply. + Excellent full-time benefits including comprehensive medical coverage, dental, and vision options + Life and disability insurance + 401(k) with company match + Paid vacation and holidays **Eurofins USA Consumer Product Testing is a Disabled and Veteran Equal Employment Opportunity employer.**
    $35k-55k yearly est. 8d ago
  • Operations Specialist II

    Mallinckrodt Pharmaceuticals 4.8company rating

    Berwyn Heights, MD job

    Shift Operations Specialist The Shift Operations Specialist will be directly involved in the manufacture of our products to the highest standards of safety, potency, efficacy and quality. The role will work within the guidelines of cGMP to ensure conformance with all regulatory requirements and site SOPs, while assisting in the implementation of process improvements and enhancements. The Shift Operations Specialist will be directly involved in the manufacture of our products to the highest standards of safety, potency, efficacy and quality. The role will work within the guidelines of cGMP to ensure conformance with all regulatory requirements and site SOPs, while assisting in the implementation of process improvements and enhancements. Essential Functions * Responsible for execution of all tasks associated with the preparation for and production of Mallinckrodt products in a cGMP environment ensuring full attention to detail and excellent documentation skills. * Assist in maintaining a safe, cGxP compliant work environment at all times. * Responsible for completion of tasks according to SOPs and Production batch records (PBR's) * Participate on project teams through all phases of the start-up projects; these phases will include Equipment installation and start up, commissioning, validation, and qualification of equipment. * Support introduction of new products into sustaining operations through the execution of Product Demonstration and Validation activities * Support Engineering, calibration, and utility equipment maintenance activities - Perform initial troubleshooting of issues identified during start-up and routine operations. * Drafting and updating of area SOPs, and batch records. * Assist with the training of colleagues in SOPs, process execution and equipment operation. * Provide support to Quality Operations where required. * Drive a culture of Engagement and Continuous Improvement through identifying and implementing opportunities for improvement in process efficiency and compliance. * Provide support for initiation and completion of deviations, CAPAs, and change controls for process systems Minimum Requirements Education / Experience / Skills: * Working knowledge of production operations with a strong focus on attention to detail and compliance to all regulatory standards. * An ability to work independently and as part of a team. The individual in this position will be able to organize their own work on a routine basis and requires minimal supervision. * Minimum certificate level qualification in a related discipline (Chemistry, Engineering, Biotechnology etc.) plus 2-3 years relevant experience in a cGMP commercial manufacturing environment. * Knowledge of GMP utility systems (i.e., WFI, clean steam, pharmaceutical gas systems) is desirable * Experience in working in cross functional teams. * This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities required of the incumbent. Incumbents may be asked to perform other duties as required. * Good interpersonal and communication skills, verbal and written. * Collaborator with strong levels of engagement with individuals and teams. * High level of delivery and work completion. A proven track record of delivering on commitments. * A knowledge of Continuous improvement principles and tools. Organizational Relationship/Scope: The Operations Specialist is a key frontline role reporting directly to the Operations Lead at College Park Mallinckrodt Pharmaceuticals Manufacturing facility. Working Conditions: This will be a shift-based role with a shift allowance as part of the renumeration package. Due to the nature of this frontline position, on site work is a requirement.
    $63k-79k yearly est. Auto-Apply 1d ago
  • Systems Administrator

    Eurofins Scientific 4.4company rating

    Baltimore, MD job

    Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. Job Description Location: Baltimore, MD - This position requires working on-site at our Baltimore office 5 days per week, with up to 25% travel to company sites (typically one week per month). Position Overview: The Systems Administrator is a key IT professional responsible for the configuration, management, and maintenance of the organization's computer systems. This role involves ensuring the secure and efficient operation of the company's infrastructure, including hardware, software, and network components. The Systems Administrator will support troubleshooting, system performance monitoring, and will collaborate with internal teams and third-party vendors to resolve technical issues. Core Responsibilities: * Infrastructure Support: * Resolve Help Desk tickets, including troubleshooting, software installations, hardware replacements, and addressing general IT issues from end users. Demonstrate ability to determine if and when escalation is appropriate and route to the appropriate support person or IT manager. * Maintain and manage network infrastructure (VPN, WiFi, LAN), ensuring connectivity and stability across all systems. * Administer databases, including storage monitoring and cleanup (e.g., K: drive), system backups, and server maintenance. * Manage Microsoft Azure and Active Directory environments, ensuring proper functionality and security. * Participate in infrastructure migration projects in collaboration with the corporate IT team, under the direction of your local manager. * Oversee implementation of IT Security compliance, including antivirus software, such as SentinelOne. * Maintain and support printer services to meet site requirements * Manage user access and permissions for Teamup.com and additional systems as applicable * Server Administration: * Oversee the installation, configuration, and maintenance of servers to ensure uptime and efficiency. * End-User Device Management: * Handle user account setups, laptop configuration, deployment for onboarding and departures. * In the event that a device cannot be located or is lost, be proactive to find the device by discussing with the employee directly or if applicable, their manager (for terminated users), as well as HR. * Application Support: * Provide support for internally developed applications, including METrak, Fabric, Scheduling software, Sharepoint and other customized applications. * Act as a liaison with third-party vendors for application enhancements, modifications, and troubleshooting. * Other duties as deemed appropriate by management and for which management believes adequate experience exists, or for which knowledge can be easily obtained in order to perform such duties. Employee Standards: * Support departmental and organizational objectives in a collaborative manner. * Exhibit a positive, enthusiastic, and professional attitude at all times. * Maintain a high standard of customer service with a solution-oriented approach to requests. * Adhere to manager directives and company policies, ensuring timely and accurate completion of tasks. * Demonstrate professionalism in both appearance and demeanor. * Be punctual and arrive prepared to perform job duties efficiently. * Communicate clearly and professionally with both internal and external stakeholders. * Foster respect and inclusivity in all workplace interactions. Qualifications Required Qualifications: * Authorization to work in the United States indefinitely, without restriction or sponsorship. * Bachelor's degree in Computer Science, Information Technology, or a related field (preferred). * Industry certifications such as Microsoft Certified Systems Administrator (MCSA) or CompTIA Network+ (preferred). Skills and Requirements: * Exceptional verbal and written communication skills, with the ability to explain technical concepts to non-technical individuals. * Strong interpersonal skills, with the ability to collaborate effectively across teams and departments. * Ability to maintain confidentiality and handle sensitive information with discretion. * Receptive to constructive feedback and able to integrate guidance into work processes. * Strong problem-solving skills, particularly in high-pressure or challenging situations. * Attention to detail, with the ability to prioritize multiple tasks and meet deadlines. * Professional appearance and demeanor, representing the company in a positive manner. Physical Demands: * Ability to sit or stand for extended periods. * Capacity to lift up to 20 pounds as needed for equipment management and support tasks. Additional Information Compensation: * Salary: $95k to $110k Schedule: * Monday-Friday 8:30am -5:00pm What we offer: * Excellent full time benefits including comprehensive medical coverage, dental, and vision options * Life and disability insurance * 401(k) with company match * Paid vacation and holidays Eurofins USA Consumer Product Testing is a Disabled and Veteran Equal Employment Opportunity employer.
    $95k-110k yearly 13d ago
  • Director Project Management

    Pharmaceutics International Inc. 4.5company rating

    Pharmaceutics International Inc. job in Maryland

    Job
    $82k-118k yearly est. Auto-Apply 60d+ ago
  • Inside Sales Representative

    Eurofins Scientific 4.4company rating

    Baltimore, MD job

    Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. Job Description Responsibilities: * Work with assigned sales executives providing support with quotations, orders and CRM related duties. * Provide onsite support for all remote Sales Executives when needed including receiving and hosting customers at the lab, following up on action items with Department Managers, and other duties as requested. * Follow up with customers and prospects on inquires and prepared proposals. * Customer Service support including data entry, project set up, updating CRM, new vendor/accounts processing. * Maintain & update Dynamics, CRM, Salesforce (OR OTHER) database. * Adding customer companies/contact's information to database. * Ensure that all information input during request for quote processing is accurate and all relevant fields are completed. * Maintain relevant notes that pertain to a project or opportunity. This includes correspondence/communication between personnel and correspondence/communication between Project Coordinator (PC) and the customer. * Support project coordination team to maintain existing customer accounts to ensure customer satisfaction with prompt and courteous service. * Follow up promptly on completed projects as requested by project coordinator to receive customer feedback and next opportunities. Provide feedback from customers to Sales Executives, Department Managers, and leadership team as needed. * Outbound calling and emailing from data bases as directed by Sales Manager, re-engagement with passive accounts. * Interdepartmental support of company sponsored events or miscellaneous administrative tasks. * Other duties as assigned. Qualifications * This is a high profile position that requires interactions with sales and project coordination team. * This position requires excellent organizational and interpersonal skills. * The candidate must be able to work well and communicate effectively with all levels of management and staff as a team member and be able to work independently with minimal supervision. * Must perform well under pressure in a fast paced environment. * This position requires initiative, judgment and professionalism, and skill in composing a variety of written and electronic materials. * The candidate should have excellent computer skill and superior proficiency at Microsoft Office applications (Work, Outlook, Excel, and Visio) and Internet Explorer. Additional Information Schedule: * Monday-Friday 8:00am-5:00pm What we offer: * Excellent full time benefits including comprehensive medical coverage, dental, and vision options * Life and disability insurance * 401(k) with company match * Paid vacation and holidays Eurofins USA Consumer Product Testing is a Disabled and Veteran Equal Employment Opportunity employer.
    $39k-74k yearly est. 60d+ ago
  • QC Data Reviewer I

    Pharmaceutics International Inc. 4.5company rating

    Pharmaceutics International Inc. job in Maryland

    The Quality Control Data Reviewer I is responsible for the accurate and timely review of analytical data generated in the QC laboratory. This entry-level role ensures all documentation meets regulatory, internal, and client requirements in support of pharmaceutical product development and manufacturing. The Data Reviewer I will verify compliance with Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and related company standard operating procedures (SOPs), state, FDA, local laws and international (e.g., EU, Chinese, Japanese) as applicable to maintain data integrity across analytical activities. Duties/Responsibilities: Perform thorough review of analytical chemistry testing data for completeness, accuracy, and compliance with SOPs, test methods, and applicable regulatory standards. High-performance Liquid Chromatography (HPLC) Gas chromatography (GC) Dissolution Integrated Software Empower 3. UV-Vis Spectrophotometer Mastersizer 3000 for Particle Size Distribution (PSD) Karl Fischer (KF) pH Data Review of Analytical Chemistry Testing: Raw Material (RM) including API (active pharmaceutical ingredients) and excipients In Process (IP) Testing Clinical Verification Packaging Material Components Review the data to Comply with GLPs, cGMPs, and GDP (Good Documentation Practice). Confirm that calculations, units, and transcriptions are correct and traceable. Ensure chromatographic integrations and results are scientifically sound and compliant with established protocols. Verify that all test methods and procedures are properly followed and documented. Identify, document, and escalate any data discrepancies or deviations for investigation. Maintain a thorough understanding of current USP, EP, and ICH guidelines related to QC testing. Support audit readiness and participate in internal/external audits as needed. Collaborate closely with analysts, supervisors, and QA to resolve issues and ensure timely batch release. Maintain good documentation practices (GDP) and support data archival processes. Continuously improve and educate analytical chemists to improve analytical data reporting, adhering to GDP and cGMP to increase efficiency, compliance, and Quality. Review analytical data to ensure ALCOA+. Ensure compliance of testing with laboratory procedures, test methods, and protocols. Work with laboratory personnel to correct any errors and omissions in GMP documentation and promote a cGMP culture. Ability to pay attention to detail, focus, and multitask on review of analytical laboratory data. Adhere to the Safety and Health Program and associated plans. Review time of use logs on cGMP instrumentation and other analytical equipment. Completion of work within the assigned time frame, to perform or assist in general organizational tasks including open tasks and timelines and tracking of tasks. Knowledge of QA events/deviations/Investigations. Any other responsibilities are assigned by the manager or department head. Required Skills/Abilities: Demonstrates excellent personal organizational skills Knowledgeable in Pharmaceutical industry regulations Health and Safety Awareness Must work as a team member in the QC Lab environment Education and Experience: Bachelor's degree or higher, in Chemistry, Pharmacy, Sciences, or Quality (QA/QC), or equivalent work experience 0-3 years of relevant work experience in Quality Assurance/Data review of Chemistry QC in the pharmaceutical industry. Experience in all areas of Pharmaceutical, e.g., CMO, CDMO, Clinical and commercial products is preferred. Experience with MS Programs such as Word, Excel, PowerPoint, Access, Project, Proofreading skills, etc. Knowledge of Quality Management Systems such as Master Control. Knowledge of current federal, local, and international regulations regarding the Testing, production, and release of drug substances and products. · Basic understanding of analytical techniques (e.g., HPLC, GC) and laboratory data documentation requirements. · Familiarity with cGMP, GLP, and regulatory compliance standards (FDA, EMA, ICH). · Proficient in Microsoft Office (Word, Excel, Outlook); experience with electronic laboratory systems (e.g., Empower, LIMS, LabWare) is an advantage. · Strong communication, organizational, and time management skills. Ability to manage multiple priorities and re-prioritize tasks as required. Strong attention to detail and ability to detect data inconsistencies. Excellent problem-solving skills. Physical Requirements: • Fluent in English • Ability to travel between and within facilities to visit staff, operations, projects, etc. • Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary). • Ability to lift up to 40 pounds on occasion. • Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary). All job requirements in the provided indicate the level of knowledge, skills, and/or abilities deemed necessary to perform the job competently. Job descriptions are an overview of the duties, responsibilities, and requirements of the position. Employees may be required to perform other job-related assignments as requested.
    $42k-56k yearly est. Auto-Apply 60d+ ago
  • Facilities Mechanic

    Catalent Pharma Solutions, Inc. 4.4company rating

    Severn, MD job

    * Shift: Night shift 6pm-6am * 100% on-site Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. The Facilities Mechanic is responsible for the operation, maintenance, and troubleshooting of a GMP Facility, key utilities, equipment and laboratory systems to support manufacturing and research operations. The role: * Operates and maintains and repairs utility systems - HVAC, clean steam generator, chiller, usp-water/DI water skids, WFI systems, plant steam boilers, air compressors etc. * Assists management writing operational protocol(s) and preventive maintenance and calibration. * Accurately completes/maintains all equipment logbooks and maintenance records. * Routinely troubleshoots/repairs laboratory and manufacturing equipment such as fermenters, pumps, filtration skids, freezers, etc. * Participates in facility expansion and validation projects. * Recommends parts/supply purchases for equipment within the manufacturing/lab areas. * Works closely with manufacturing/lab staff to troubleshoot and repair equipment problems. * Works under general supervision to meet project goals. * Works closely with various departments at Catalent and offers assistance as needed. * Follows Catalent safety procedures, practices and cGMP. * Perform other duties as assigned. The candidate: * High School Diploma or equivalent. * 3+ years' related experience (biologics manufacturing, GMP environment, hospital, food, chemicals). * Able to communicate effectively in English, with supervisors, other technicians, and contractors. * Basic understanding of mechanical and electrical systems in a biopharmaceutical manufacturing/R&D facility, supporting the GMP production of Phase I/II bulk Biologics. * Basic math and computer skills (WORD, EXCEL) and must be familiar with building automation systems (BAS). * Must obtain Grade 3 Stationary Engineer's License within the first year of service. * Good mechanical ability for troubleshooting and repairing equipment. * Experience in working in an FDA regulated, cleanroom environment that requires full gowning (Tyvek coverall, gloves, hair cover, shoe covers). * Must be able to clearly communicate in English (verbally and written). The anticipated salary range for this position in Maryland is $70,000-$85,000 plus an annual bonus target. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. Why you should join Catalent: * Competitive medical benefits and 401K * 152 hours PTO + 8 Paid Holidays * Dynamic, fast-paced work environment * Opportunity to work on Continuous Improvement Processes Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.
    $70k-85k yearly Auto-Apply 14d ago
  • QC Chemist, Raw Materials

    Pharmaceutics International Inc. 4.5company rating

    Pharmaceutics International Inc. job in Cockeysville, MD

    Under minimal supervision of QC management, the QC Chemist performs physical and chemical testing on raw materials, in-process and finished products, as well as stability samples. Utilizes established methods and standard operating procedures and laboratory equipment to perform testing of materials. Prepares high quality written documentation, such as notebooks, logbooks, standard operating procedures (SOPs) and LIMS reports. Trouble shoots analytical equipment. Provides training on analytical methods and new technologies. Responsibilities: Performs analytical testing of raw materials, in-process materials, finished products and stability samples. Operates laboratory equipment such as balances, pH meters, hardness testers, particle size analysis, LOD, Karl Fischer, Melting Point, etc. in accordance with laboratory SOPs and test methods. Effectively performs routine testing using HPLCs, GCs, UV-VIS, FT-IR and ICP-MS equipment in accordance with SOPs and test methods. Performs data analysis and evaluation of test results. Prepares reports and reviews data. Maintains accurate records of test data, maintains laboratory notebooks and logbooks in accordance with company guidelines and GDPs. Assists in writing and revising SOPs and tests methods as needed. Follows documented procedures: SOPs, test methods, and transfer protocols. Performs routine maintenance, calibration, and performance verification on applicable instruments. Performs investigation activities and writes deviation and investigation reports. Suggests and writes CAPAs. Follows lab safety procedures. Perform other duties as assigned. Qualifications: Bachelors in chemistry or related physical/biological science, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities. Minimum of 3 years' experience in Pharmaceutical Analysis Must understand analytical chemistry. Demonstrated knowledge of cGMP regulations and ICH guidelines Computer literacy and ability to use data acquisition and processing software, such as EMPOWER 3 Demonstrate the ability to read, analyze, and interpret USP/NF methods, SOPs and technical procedures manuals, and batch records. Demonstrate the ability to define problems, collect data, establish facts, and draw valid conclusions; interpret an extensive variety of technical instruction in mathematical or diagram form. Knowledge of basic laboratory practices, methods, and techniques Demonstrate the ability to carry out work assignments communicated orally or in writing. Demonstrate familiarity with Lean Six Sigma Methodologies and proven analytical/ problem solving capabilities. Demonstrates the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates. Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision. Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required. Must be able to comprehend and follow all applicable SOPs. Demonstrate ability to acquire the appropriate knowledge from resources on with electronic Quality Management Systems such as MasterControl and Trackwise. Demonstrate understanding of the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products. Good understanding of cGMPs, industry, and regulatory standards and guidelines. Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc. Demonstrate the ability to portray the appropriate level of integrity and professionalism. Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats. Demonstrate the ability to complete tasks accurately and according to established and shifting timelines. Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions. Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment. Results-oriented and efficient. Creative and open-minded who fosters an environment in which sharing of ideas is encouraged. Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally). Demonstrate the ability to work well in a cross-functional team environment. Must communicate fluently in English and have legible handwriting. Physical Demands: Ability to travel between and within facilities to visit staff, operations, and projects, as needed. Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary). Ability to lift up to 40 pounds on occasion. Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).
    $60k-77k yearly est. Auto-Apply 60d+ ago
  • Senior Facilities Engineer

    Catalent Pharma Solutions, Inc. 4.4company rating

    Severn, MD job

    The Sr. Facilities Engineer will provide engineering support of critical utilities used in GMP manufacturing. This individual will work with the Facilities and Engineering teams, as well as Manufacturing to design and scale-out manufacturing capability and support manufacturing operations, as well as improve existing manufacturing operations and facilities. Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. The role: * Lead the design, implementation, and commissioning for new utility equipment and modifications to existing utility equipment and facilities within GMP Manufacturing * Author and review protocols, standard operating procedures, and provide technical assessment and approval for engineering and process changes * Work with industry /consultants to create design specifications, P&ID drawings, GA drawings, User Requirements, Functional Specifications and automation control strategies. * Write and review technical documentation such as protocols and reports for FATs, SATs, and IQ/OQ/PQ testing. * Provide technical solutions to facility and utility equipment problems * Perform investigations of manufacturing deviations and anomalies related to failure of facility systems. * Perform utility monitoring, utility capability, statistical analysis and quality engineering activities. The candidate: * Bachelor's degree in Chemical, Biochemical or Mechanical Engineering, Biotechnology or equivalent and Five (5) years of related experience * Associate's degree in Chemical, Biochemical or Mechanical Engineering, Biotechnology or equivalent and Seven (7) years of related experience * In-depth understanding and knowledge of Clean Utility Systems including; WFI generation and distribution, purified water generation and distribution, clean steam generation and distribution, HVAC for clean rooms, and clean gas generation and distribution The anticipated salary range for this position in Maryland is $93,280-$128,260 plus an annual bonus. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. Why you should join Catalent: * Competitive medical benefits and 401K * 152 hours PTO + 8 Paid Holidays * Dynamic, fast-paced work environment * Opportunity to work on Continuous Improvement Processes Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to ***************** for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.
    $93.3k-128.3k yearly Auto-Apply 14d ago
  • Test Engineer, Environmental Simulation Laboratory (ESL)

    Eurofins Scientific 4.4company rating

    Baltimore, MD job

    Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. Job Description Employee Standards: * Support department objectives and company goals * Be a team player * Sustain a positive, enthusiastic and professional attitude at all times * Accommodate requests with a smile and "can do" attitude * Adhere to manager directives * Maintain a professional appearance and demeanor * Arrive on time, properly dressed and prepared to work * Perform all duties in a timely, accurate, honest and professional manner * Communicate with customers professionally and in accordance with customer service standards * Be respectful of others Tasks/Responsibilities: * Directly interface with clients - assist in helping our clients prepare for testing and working with them to overcome challenges * Schedule and own assigned projects- from introduction call to the issuance of the test report. * Efficient assignment of tasks to Technicians * Analyze, interpret communicate and demonstrate expert knowledge in strategic testing disciplines. * Perform Environmental Simulation testing using test equipment and software * Perform mechanical designs using CAD software * Assign and provide technical oversight to Test Technicians for your projects * Assist with project scoping and quoting efforts when needed * Assist in ISO 17025 technical audits * Perform project scoping and quoting efforts * Organization and clean-up of your assigned zone of the facility * Meet or exceed assigned goals and objectives * Stay current with strategic testing discipline by following changes and updates to standards and directives. * Other duties as deemed appropriate by management and for which management believes adequate experience exists, or for which knowledge can be easily obtained in order to perform such duties. Qualifications * Bachelor Degree in Mechanical Engineering or equivalent industry knowledge * Four years of experience in performing vibration/shock testing and other environmental simulation tests. * Experience is performing mechanical design and working with CAD software, such as Solidworks * Basic understanding of electricity and electronics * Experience with Microsoft Office (Word, Excel and Outlook) * Ability to follow simple block diagrams/schematics * Clean driving record * Authorization to work in the United States indefinitely without restriction or sponsorship Reporting: This position reports directly to the Manager, Environmental Simulation (ENV) Skills/Requirements: * Ability to maintain confidentially * Needs to be receptive to and accepting guidance from others * Ability to deal with difficult people and problems * Able to work well in a team environment * Able to work in a diverse group of people * Attention to detail * Willing to work overtime as necessary * Ability to multi-task and prioritize assignments * Perform other duties as assigned * Travel as needed Physical Demands: * Able to sit for long periods of time * Able to lift up to 30 pounds * Ability to climb ladders and use scissor lifts to mount devices, such as antennas * Ability to safely use power tools and perform light machining Additional Information Compensation: * Salary: $65,000-$75,000 Schedule: * Monday-Friday 8:30am-5:00pm What we offer: * Excellent full time benefits including comprehensive medical coverage, dental, and vision options * Life and disability insurance * 401(k) with company match * Paid vacation and holidays Eurofins USA Consumer Product Testing is a Disabled and Veteran Equal Employment Opportunity employer.
    $65k-75k yearly 60d+ ago
  • Test Technician

    Eurofins Scientific 4.4company rating

    Baltimore, MD job

    Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2020, Eurofins generated total revenues of EUR € 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years. Job Description: This is both a technical and client-facing role that would suit someone who is currently working in an Engineering environment or working for a certification body or test laboratory; and who is enthusiastic, pragmatic, and thorough and who enjoys being part of a growing team. Experience is preferred at this stage, but we are also willing to discuss other roles and opportunities with newly qualified candidates. As the Test Technician, you will be responsible for the coordination and execution of testing services at the site level and collaborate on cross functional programs in support of inter company projects. Responsibilities: * Support assigned projects- from assignment to the issuance of the test reports. * Perform Environmental Simulation testing using test equipment and software. * Maintain accurate and complete test records. * Continuously review and update METrak and Team up scheduling system in accordance with formal training. * Participate in technical audits demonstrating knowledge in strategic testing disciplines. * Directly interface with clients - assist in helping our client's set-up for testing and work with them to overcome challenges. * Provide ongoing communication to the Engineering team to ensure that all client issues are understood and addressed in a timely manner. * Organization and clean-up of the laboratory and facility. * Meet or exceed assigned goals and objectives. * Stay current with strategic testing discipline by following changes and updates to standards and directives. * Other duties as deemed appropriate by management and for which management believes adequate experience exists, or for which knowledge can be easily obtained in order to perform such duties. Qualifications * Associate's degree in engineering, or related field preferred. Equivalent work experience may also be considered for this position. * Familiarity with a variety of test instrumentation, project management, and mechanical aptitude is a must. * Experienced computer literacy, database management, effective oral/written communication, basic project management skills. * Ability to follow written procedures and follow basic safety guidelines and given instructions. * Ability to supervise a difficult schedule and complete tasks, correctly and on time. * Authorization to work in the United States indefinitely without restriction or sponsorship Additional Information What we offer: * Excellent full time benefits including comprehensive medical coverage, dental, and vision options * Life and disability insurance * 401(k) with company match * Paid vacation and holidays * Pay Range: $50,000 - $55,000 Eurofins USA Consumer Product Testing is a Disabled and Veteran Equal Employment Opportunity employer.
    $50k-55k yearly 60d+ ago
  • QC Data Reviewer I

    Pharmaceutics International Inc. 4.5company rating

    Pharmaceutics International Inc. job in Huntingtown, MD

    The Quality Control Data Reviewer I is responsible for the accurate and timely review of analytical data generated in the QC laboratory. This entry-level role ensures all documentation meets regulatory, internal, and client requirements in support of pharmaceutical product development and manufacturing. The Data Reviewer I will verify compliance with Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and related company standard operating procedures (SOPs), state, FDA, local laws and international (e.g., EU, Chinese, Japanese) as applicable to maintain data integrity across analytical activities. Duties/Responsibilities: Perform thorough review of analytical chemistry testing data for completeness, accuracy, and compliance with SOPs, test methods, and applicable regulatory standards. High-performance Liquid Chromatography (HPLC) Gas chromatography (GC) Dissolution Integrated Software Empower 3. UV-Vis Spectrophotometer Mastersizer 3000 for Particle Size Distribution (PSD) Karl Fischer (KF) pH Data Review of Analytical Chemistry Testing: Raw Material (RM) including API (active pharmaceutical ingredients) and excipients In Process (IP) Testing Clinical Verification Packaging Material Components Review the data to Comply with GLPs, cGMPs, and GDP (Good Documentation Practice). Confirm that calculations, units, and transcriptions are correct and traceable. Ensure chromatographic integrations and results are scientifically sound and compliant with established protocols. Verify that all test methods and procedures are properly followed and documented. Identify, document, and escalate any data discrepancies or deviations for investigation. Maintain a thorough understanding of current USP, EP, and ICH guidelines related to QC testing. Support audit readiness and participate in internal/external audits as needed. Collaborate closely with analysts, supervisors, and QA to resolve issues and ensure timely batch release. Maintain good documentation practices (GDP) and support data archival processes. Continuously improve and educate analytical chemists to improve analytical data reporting, adhering to GDP and cGMP to increase efficiency, compliance, and Quality. Review analytical data to ensure ALCOA+. Ensure compliance of testing with laboratory procedures, test methods, and protocols. Work with laboratory personnel to correct any errors and omissions in GMP documentation and promote a cGMP culture. Ability to pay attention to detail, focus, and multitask on review of analytical laboratory data. Adhere to the Safety and Health Program and associated plans. Review time of use logs on cGMP instrumentation and other analytical equipment. Completion of work within the assigned time frame, to perform or assist in general organizational tasks including open tasks and timelines and tracking of tasks. Knowledge of QA events/deviations/Investigations. Any other responsibilities are assigned by the manager or department head. Required Skills/Abilities: Demonstrates excellent personal organizational skills Knowledgeable in Pharmaceutical industry regulations Health and Safety Awareness Must work as a team member in the QC Lab environment Education and Experience: Bachelor's degree or higher, in Chemistry, Pharmacy, Sciences, or Quality (QA/QC), or equivalent work experience 0-3 years of relevant work experience in Quality Assurance/Data review of Chemistry QC in the pharmaceutical industry. Experience in all areas of Pharmaceutical, e.g., CMO, CDMO, Clinical and commercial products is preferred. Experience with MS Programs such as Word, Excel, PowerPoint, Access, Project, Proofreading skills, etc. Knowledge of Quality Management Systems such as Master Control. Knowledge of current federal, local, and international regulations regarding the Testing, production, and release of drug substances and products. · Basic understanding of analytical techniques (e.g., HPLC, GC) and laboratory data documentation requirements. · Familiarity with cGMP, GLP, and regulatory compliance standards (FDA, EMA, ICH). · Proficient in Microsoft Office (Word, Excel, Outlook); experience with electronic laboratory systems (e.g., Empower, LIMS, LabWare) is an advantage. · Strong communication, organizational, and time management skills. Ability to manage multiple priorities and re-prioritize tasks as required. Strong attention to detail and ability to detect data inconsistencies. Excellent problem-solving skills. Physical Requirements: • Fluent in English • Ability to travel between and within facilities to visit staff, operations, projects, etc. • Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary). • Ability to lift up to 40 pounds on occasion. • Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary). All job requirements in the provided indicate the level of knowledge, skills, and/or abilities deemed necessary to perform the job competently. Job descriptions are an overview of the duties, responsibilities, and requirements of the position. Employees may be required to perform other job-related assignments as requested.
    $41k-57k yearly est. Auto-Apply 60d+ ago

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Pharmaceutics International may also be known as or be related to Pharmaceutics International, Pharmaceutics International, Inc. and Pii (Pharmaceutics International, Inc).