Senior Process Engineer

3 days ago

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Logo of Verista, Inc.

Verista, Inc.

computer system validation • CQV • QMS • automation engineering • R&D

Description

•Verista’s team empowers growth and innovation in the life science industry to solve business needs. •They help researchers, organizations, and companies tackle pressing healthcare challenges. •The culture emphasizes empowerment, client success, courage, inclusivity, and skill acquisition. •Responsibilities include developing PV protocols, coordinating with teams, ensuring compliance, and mentoring.

Requirements

•Strong 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 evaluations •Demonstrated experience developing and executing Process Validation Protocols •High level understanding of Process Performance Qualification processes •Excellent technical writing abilities •Ability to mentor and guide lesser experienced team members •Ability to communicate effectively with clients •Proven ability to identify areas of business expansion and report to management team for follow-up •Strong understanding of the three stages of Process Validation: Process Design, Quality Control, and Continuous Process Verification •Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate. •Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client’s organization •Intermediate Microsoft Project capabilities •6-10 years of relevant role specific experience •6-10 years of industry experience

Benefits

•High growth potential and fast-paced organization with a people-focused culture •Competitive pay plus performance-based incentive programs •Company-paid Life, Short-Term, and Long-Term Disability Insurance. •Medical, Dental & Vision insurances •FSA, DCARE, Commuter Benefits •Supplemental Life, Hospital, Critical Illness and Legal Insurance •Health Savings Account •401(k) Retirement Plan (Employer Matching benefit) •Paid Time Off (Rollover Option) and Holidays •As Needed Sick Time •Tuition Reimbursement •Team Social Activities (We have fun!) •Employee Recognition •Employee Referral Program •Paid Parental Leave and Bereavement

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