Verista's600 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines & Values: We empower and support our colleaguesWe commit to client success at every turnWe have the courage to do the right thingWe encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.We constantly acquire new skills and learn from our experiences to enhance our collective expertiseMES Process Engineer Responsibilities: Serve as the primary support for the MES Syncade system, ensuring its seamless integration with manufacturing processesDevelop a deep understanding of manufacturing workflows to optimize and enhance processes with MESReview Functional Requirement Specifications (FRS) and test scripts for alignment with manufacturingIndependently design experiments and evaluate data in support of improvements and investigationsSupport failure investigations and implementation of solutions (CAPAs) that solve manufacturing and product problems, follow up on CAPAs to determine effectiveness and suitability and prepare/review written reports in a timely fashionDraft technical reports in support of manufacturing process changes, optimizations, and regulatory filingsProvide technical guidance and leadership to lesser experienced team membersEnsure maintenance/ required control of records of qualification and validation, Change Controls, Risk Assessments and CAPAs for future compliance auditsThe ideal candidate must have knowledge of process manufacturing, field instrumentation, control system installation and implementation expertise in all of the following project phases: Requirements documentation, detailed design generation, implementation, system integration, testing and on-site startup. Plans and coordinates technical design and engineering implementation of project work4 - 6 years of role relevant experienceStrong understanding of biological process validation activities including drug substance manufacturing processes, drug product filling processes, process simulations (media fills), filtration, mixing, sterilization, lyophilization, and completion of validation risk assessments and evaluationsAbility to mentor and guide lesser experienced team membersAbility to communicate effectively with clientsProven ability to identify areas of business expansion and report to management team for follow-upStrong understanding of the three stages of Process Validation: Process Design, Quality Control, and Continuous Process VerificationObvious business maturity and interpersonal skills to be able to effectively communicate and collaborateExperience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client's organizationIntermediate Microsoft Project capabilitiesWhy Choose Verista?
High growth potential and fast-paced organization with a people-focused cultureCompetitive pay plus performance-based incentive programsCompany-paid Life, Short-Term, and Long-Term Disability Insurance.Medical, Dental & Vision insurancesFSA, DCARE, Commuter BenefitsSupplemental Life, Hospital, Critical Illness and Legal InsuranceHealth Savings Account401(k) Retirement Plan (Employer Matching benefit)Paid Time Off (Rollover Option) and HolidaysAs Needed Sick TimeTuition ReimbursementTeam Social Activities (We have fun!)Employee RecognitionEmployee Referral ProgramPaid Parental Leave and BereavementFor more information about our company, please visit us atVerista.com For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future. $70,491-112,515 *Verista is an equal opportunity employer.
#J-18808-Ljbffr