Senior Process Engineer - 4365

Verista’s 600 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 colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We 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 expertise

Senior Process Engineer Responsibilities:

Resources to support facility startup efforts. Technical resource to serve as a Process/Production Engineer in support of the facility startup: Media Fills, Stability batches, water runs, PV batches, general production startup. Individual should have a clear understanding of Data Integrity and Change Control requirements and a clear understanding of how to interface with and navigate equipment HMI’s, to operate, troubleshoot and improve system operation. Person will be part of a focused/autonomous team to expedite startup activities and ensure success of a manufacturing area/line/process.

Resource will report into the Lead Process Engineer and/or Process Engineer Manager at the site and will work directly with cross functional teams (Automation, Operations, quality, Maintenance, Reliability, Instrumentation, Validation and MSAT), within the operations space to support technical issues, provide engineering assessments of events for process/product impact, identify and facilitate process improvements and robustness, perform data analysis for RC determination and process optimization, lead troubleshooting efforts, own and support change control, and work side by side with operations daily in support of optimization efforts for preparing the site for BAU (business as usual). BAU support will include document reviews/edits to enhance process/machine specifications, procedures, job aides, training, and improved methods of work to streamline the processes. Provide coaching and knowledge transfer to operations and maintenance personnel. Person is expected to have a strong technical understanding of relevant processes and able to understand established system matrices for products and commodities, able to perform protocol development for engineering studies, execution of testing to define process parameters/ capability to include recipe development and parameter identification. All work to be performed according to site procedures using cGMP and good documentation practices and performed against site commitments/needs. Work will include 12 hour shift coverage working a 3-2-3 work schedule in support of multiple shifts of operations. Resource is expected to have a solid understanding of mechanical systems, system controls and instrumentation. Persons will be expected to help build knowledge management systems/engineering playbooks as well as use of OsiPi to build dashboards for their respective areas of support.

Personnel are expected to work 100% onsite and within the operations area (clean room areas, gowning required). Personnel may require Aseptic training/certification for the job role, so person must be able to work within cleanrooms for extended periods daily. Persons with technical knowledge and understanding of the following processes/technologies/applications are preferred:

• TPO filling
• Commodity Washers
• Depyrogentation tunnels
• Cappers
• CIP/SIP processes
• Formulation tanks/transfer systems
• ATEC stopper processing
• Partswashers
• Autoclaves
• VHP processes (chambers/Isolators)
• OsiPi
• Batch Engines
• SCADA systems
• Production/GMP Documentation – protocol generation, SOPs, Batch Records, Training aides, GMP regulations, PDOCS, EQMS/QTS, EAMS

Requirements

• Work 12 hour shift following a 3-2-3 work schedule
• Demonstrated delivery of Process Engineer 2 level requirements
• Demonstrated capability to deliver on the Senior Process Engineer 1 Responsibilities
• 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
• 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
• 4-6 years of relevant role specific experience
• 4-6 years of industry experience
• 3 years of pharmaceutical sterile injectables experience

Benefits

Why Choose Verista?

• 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

For more information about our company, please visit us at Verista.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.

Salary Range: $115,000-127,000

*Verista is an equal opportunity employer.