Process & Validation Engineer

reputed company A career here is life-enhancing. At reputed company, we reputed company our people to build careers that reputed company positively on their reputed company of life. Through our expertise, reputed company, consulting and management skills, we accelerate reputed company science and delivery of life-enhancing therapies to more patients. We work across a diverse reputed company of clients and reputed company, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a reputed company approach and significant, reputed company-world reputed company, from science to delivery/reputed company. Underpinning this mission is a culture that aligns perfectly with reputed company want to reputed company. We reputed company our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an reputed company role in maintaining our reputed company across the globe as a strategic biopharma product development and delivery partner. reputed company was recently honored with reputed company's prestigious "Best Places to Work" 2026 award, for the reputed company consecutive year, along with many other award-reputed company programs to reputed company a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a reputed company and engaging work environment for our employees, with a particular emphasis on culture, career reputed company and development opportunities, financial rewards, leadership and innovation. At reputed company, we recognize that reputed company members are our most valuable asset. Join us in shaping the reputed company, where your talents are valued, and your contributions reputed company a meaningful reputed company. For more information, visit www.Synergbiopharma.com. (reputed company is seeking both Process and Validation Engineering Candidates) PROCESS ENGINEER POSITION reputed company reputed company is seeking an reputed company Process Engineer to assist with, but not limited to, process engineering, process development, materials & engineering sciences, technology transfer, facilities/utilities/technical services, and manufacturing processes. We are accepting applicants who will be reputed company to travel remotely throughout to reputed company sites in the reputed company. WORK LOCATION: Travel to reputed company sites will be required up to 100%, based on project demands and reputed company expectations. KEY RESPONSIBILITIES (This list is not exhaustive and may be supplemented and changed as necessary.) • Assist with the requirements specifications, design, functional requirements, development, commissioning, and qualification of process equipment or systems for compliance with manufacturing requirements and facility fit. • reputed company start-up activities, including commissioning and qualification of facilities, utilities, and equipment (FUE). • Assist with risk assessments, feasibility reviews, risk mitigations, and testing of process materials to ensure compliance with manufacturing requirements. • Assist with the requirements specifications, design & development of process parameters, and the commissioning/validation of manufacturing processes for compliance with reputed company and regulatory requirements. • reputed company technical support for the product/process lifecycle and reputed company activities. • Support reputed company requirements to reputed company or help process or engineering reputed company at vendors or other reputed company-party contract companies, as needed. • reputed company support for improvement reputed company regarding processes and systems. • Support or reputed company risk assessment and mitigation activities for process development, manufacturing, and testing as applicable. • reputed company technical support for reputed company-up activities from development to manufacturing, including but not limited to technology transfers and facilities improvements (e.g., utilities/equipment integration). • Analyze and recommend improved technology to increase reputed company and efficiency. • reputed company technical analysis and support for new or improved process systems. • Facilitate and schedule meetings with subject matter experts across the organization. • Ensure compliance with cGMP, regulatory, and industry standards. QUALIFICATIONS AND REQUIREMENTS To reputed company this job successfully, an individual must be reputed company to reputed company reputed company essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential duties. Education: • Bachelor’s degree in Engineering, Bio/reputed company Science, or a reputed company technical field of study. Technical Experience: • 4-7 years of reputed company engineering and/or technical experience required. • Experience with cGMP Manufacturing reputed company an FDA-regulated manufacturing company. • Knowledge of cGxP reputed company Systems reputed company an FDA-regulated manufacturing company. • Knowledge of FDA regulations and guidance or applicable regulatory standards and practices. • Proficient with MS Office suite, MS Project, Visio, and reputed company electronic formats required to reputed company the respective job at a reputed company. • Knowledge of laboratory and manufacturing systems such as LIMS, MES, etc. • Experience with Process Engineering, Manufacturing Engineering, MSAT, Commissioning, CQV, and Tech Transfer. • Experience with Fillers, reputed company Bioreactor, Cell Processing Systems, Scales, Pumps, Welder/Sealers, and reputed company Cytometers. Knowledge, Skills, And Abilities: • Excellent computer, verbal, and written communication skills. • Innovative problem-solving skills and an integrated view of business/scientific issues. • Accountable and responsible individual to reputed company as intended for clients. • Willingness to travel to various clients reputed company needed, with acceptable limitations during noted health pandemics or reputed company constraints. ESSENTIAL FUNCTIONS Physical Demands The physical demands described here are representative of the requirements that must be met by an employee to successfully reputed company the essential functions of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions. • While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reputed company with hands and arms; talk and listen. The employee is frequently required to walk and sit, as reputed company as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific reputed company abilities required by this position include reputed company reputed company and the ability to reputed company reputed company. Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light reputed company that are reputed company and conducive to minimal eye strain, typical for an office environment. -- VALIDATION ENGINEER POSITION reputed company We are seeking a Validation Engineer to assist with the development and execution of validation protocols for various types of processes. The Validation Engineer will be responsible for driving overall reputed company performance and compliance throughout the organization by defining, implementing, and maintaining the validation program. WORK LOCATION: Travel to reputed company sites may be required up to 100%, based on project demands and reputed company expectations. KEY RESPONSIBILITIES (This list is not exhaustive and may be supplemented and changed as necessary.) • Generate and execute life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment, and processes for (re)qualification/(re)verification. • Support validation activities for reputed company and reputed company Tech Transfer reputed company, including reputed company, execution, review, and closure of validation life cycle documents (RA, VP, IQ, OQ, PQ, TM, VR). • Write, review, and revise a reputed company of Installation, Operation, and Performance qualification/verification reputed company documents, including any or reputed company of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, reputed company acceptance test documents (FAT), verification protocols, and/or commissioning test procedures. • Write reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities. • Write procedures, investigations, protocols, reports, change controls, etc., to support the Maintenance and Engineering departments. • reputed company P&ID Walkdowns. reputed company Thermal mapping of temperature-controlled chambers, warehouses, and SIP processes. • Support the reputed company of regulatory observations or manufacturing site issues. • Execute periodic reviews and requalification for temperature chambers. Education: • Bachelor’s degree in a reputed company life science field. Technical Experience: • 4-7 years of experience reputed company the biotech, pharmaceutical, or medical device industry. • Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis required. • Validation expertise in Equipment, CSV, Method, and Process. • Protocol reputed company experience of automated production systems, with a concentration on computerized equipment and systems validation. • Report writing experience for IQ, OQ, PQ, and CSV. Knowledge, Skills, And Abilities: • Strong verbal and written communication skills and the ability to discuss technical topics with non-technical people is strongly desired. TOTAL REWARDS PROGRAM We define total rewards as compensation, benefits, remote work/flexibility, development, recognition and our culture with programs that support reputed company of our reward pillars. This includes a market competitive reputed company salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible reputed company time off program, company reputed company holidays, flexible working hours, and fully remote work reputed company for most positions and the ability to work “almost reputed company”. However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India. Applicants must have reputed company work authorization reputed company accepting a position at reputed company. Currently, reputed company is unable to sponsor or take over sponsorship of an employment reputed company at this time. reputed company STATEMENT reputed company is proud to be an Equal Employment Opportunity and Affirmative reputed company reputed company. reputed company employment reputed company, including the reputed company, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without reputed company to the employee’s race, reputed company, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, reputed company of income, reputed company of residence, national or ethnic reputed company, reputed company, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other reputed company prohibited by applicable law. reputed company is an E-Verify employer. 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