5646 - Lead CQV Engineer (Upstream Manufacturing) / Lead Project Engineer

ZipRecruiter; Holly Springs (NC); On-site; USD 107,000 - 178,000; Full time

Job summary

An innovative firm is seeking a highly experienced CQV Lead to oversee commissioning and validation activities at a new drug product facility. This leadership role requires extensive experience in GMP environments, effective communication skills, and the ability to manage complex projects. The successful candidate will be instrumental in ensuring the successful delivery of CQV activities, contributing to the growth and success of the organization. Join a fast-paced, people-focused culture that values growth and collaboration, and make a significant impact in the life sciences industry.

Benefits

Competitive pay plus performance-based incentives

Company-paid Life, Short-Term, and Long-Term Insurance

Medical, Dental & Vision insurances

401(k) Retirement Plan (Employer Matching)

Paid Time Off (Rollover Option)

Tuition Reimbursement

Team Social Activities

Employee Recognition

Paid Parental Leave

Commuter Benefits

Qualifications

• 10+ years of CQV experience in GMP regulated environments.
• Experience authoring and executing FAT, SAT, IOQ, CSV protocols.

Responsibilities

• Oversee all CQV activities related to Upstream Manufacturing.
• Ensure end-to-end CQV delivery for upstream systems.

Skills

CQV (Commissioning, Qualification, and Validation)

GMP (Good Manufacturing Practice)

Communication Skills

Attention to Detail

Project Management

Education

Bachelor's Degree in Life Sciences or related field

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Job DescriptionJob Description

Description

Verista's 500 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

Responsibilities:

Our Client is seeking a highly experienced CQV (Commissioning, Qualification, and Validation) Lead to oversee all CQV activities related to Upstream Manufacturing at a new greenfield commercial drug product facility for our client in Holly Springs, NC. This leadership role will be responsible for ensuring end-to-end CQV delivery for upstream systems including single-use bioreactors, large-scale stainless steel bioreactors, and centrifuges, from inoculation through harvest.

Requirements:

• Demonstrated experience in Commissioning & Validation activities covering URS (GMP equipment)
• Demonstrated experience authoring and executing FAT, SAT, IOQ, CSV Protocols
• Must be willing to work onsite in Holly Springs, NC
• 10+ years of demonstrated CQV experience in GMP regulated environments
• 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
• Proven attention to detail and organization in project work
• Capable of working on assigned tasks without mentorship
• GMP and Good Documentation Practice training (may be completed at onboarding)
• Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
• Basic skills with EXCEL and PowerPoint
• Strong interpersonal skills and clear communication capabilities

This is an onsite role with onsite requirements in Holly Springs, NC.

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.

*Verista is an equal opportunity employer.

(US) Range$107,800—$177,093 USD

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