MES Process Engineer / Senior Process Engineer - 5052

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

MES Process Engineer Responsibilities:

Serve as the primary support for the MES Syncade system, ensuring its seamless integration with manufacturing processes

Develop a deep understanding of manufacturing workflows to optimize and enhance processes with MES

Review Functional Requirement Specifications (FRS) and test scripts for alignment with manufacturing

Independently design experiments and evaluate data in support of improvements and investigations

Support 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 fashion

Draft technical reports in support of manufacturing process changes, optimizations, and regulatory filings

Provide technical guidance and leadership to lesser experienced team members

Ensure maintenance/ required control of records of qualification and validation, Change Controls, Risk Assessments and CAPAs for future compliance audits

Requirements

The 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 work

4 - 6 years of role relevant experience

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

BenefitsWhy 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 (https://apply.workable.com/verista/) 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.$70,491-112,515Verista is an equal opportunity employer.