Senior Principal Engineer (API)

At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented workforce in our industry. Our commitment to uncompromising focus on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference.

Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation.

Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients.

Every role at Veranova plays a part in delivering an exceptional customer experience through ownership and integrity.

Role Overview:

The Senior Principal Engineer is a technical leadership role responsible for overseeing engineering activities related to the development, validation, and lifecycle management of Active Pharmaceutical Ingredient (API) manufacturing processes. This role requires deep expertise in pharmaceutical engineering, regulatory compliance, and cross-functional collaboration. The individual may lead and mentor a team of engineers while driving continuous improvement, ensuring product quality, and supporting business objectives.

Core Responsibilities:

Technical Leadership & Engineering Oversight

• Lead and provide strategic direction for engineering activities supporting API manufacturing processes.


• Mentor and manage a team of engineers, fostering technical growth and high performance.


• Serve as a subject matter expert in process engineering and validation.

Process Validation (API)

• Design, execute, and review process validation protocols and reports for API manufacturing.


• Ensure validation activities comply with regulatory requirements and internal quality standards.


• Support lifecycle process validation, including continued process verification.

Annual Product Review (APR)

• Lead and contribute to Annual Product Review activities, ensuring comprehensive evaluation of process performance and product quality.


• Identify trends, recommend improvements, and ensure timely completion of APR documentation.

New Product Introduction (NPI)

• Provide engineering support for new product introductions, including process scale-up, technology transfer, and commercialization.


• Collaborate with R&D, Quality, and Manufacturing teams to ensure smooth product launches.

CDMO Collaboration

• Work closely with Contract Development and Manufacturing Organizations (CDMOs) for process transfer, validation, and ongoing production support.


• Ensure alignment with internal standards and regulatory expectations.

Client Complaints & Investigations

• Lead or support investigations related to client complaints, deviations, and non-conformances.


• Identify root causes and implement effective corrective and preventive actions (CAPA).

Process Monitoring Programs

• Develop and maintain process monitoring strategies to ensure consistent product quality and process performance.


• Utilize statistical tools and data analysis to identify trends and drive continuous improvement.

Regulatory Inspections & Compliance

• Serve as a key representative during regulatory inspections and audits.


• Ensure engineering systems and documentation comply with cGMP and global regulatory requirements.


• Support responses to regulatory observations and commitments.

Project Management

• Lead and manage cross-functional engineering projects, ensuring delivery on time and within budget.


• Develop project plans, allocate resources, and track progress against milestones.


• Drive risk management and mitigation strategies.

Qualifications:

• Bachelor’s degree in Chemical Engineering (required)


• Master’s degree in Chemical Engineering or related field (preferred)


• Minimum of 10 years of experience in the pharmaceutical or biopharmaceutical industry, with a strong focus on API manufacturing.


• Proven experience in process validation, regulatory compliance, and engineering leadership.


• Experience working with CDMOs and external partners.


• In-depth knowledge of cGMP regulations and industry standards.


• Strong understanding of process validation, process design, and scale-up.


• Experience with process monitoring tools and statistical analysis.


• Demonstrated leadership and team management experience.


• PMP or equivalent project management certification (preferred).


• Familiarity with continuous improvement methodologies (Lean, Six Sigma).

Salary Range: $120,000-$130,000 annual base salary.

The salary range for this role is $120,000-$130,000. This range represents a good-faith estimate of the compensation we expect to offer for this position at the time of posting. Actual compensation will be based on factors such as relevant experience, skills, qualifications, and internal equity. In exceptional cases, compensation may exceed the stated range.

All full-time employees are eligible to participate in our annual incentive bonus program. Bonus targets vary by career level and are based on individual and company performance.

Our Commitment:

· Health & Wellness: Comprehensive health & wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies.

· Financial Wellness: Veranova is committed to fair and transparent compensation practices. This includes a competitive base salary, eligibility for performance-based bonuses, and an attractive 401(k) Plan with company match. Salary ranges reflect the scope and expectations of the role, and are based on market data, internal equity, and role-specific factors. Final compensation may vary depending on experience, skills, education, and business needs.

· Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs.

· Inclusive Culture: At Veranova, an inclusive culture is integral to our values. We welcome people with diverse experiences and perspectives who share our mission to improve and save lives. Even if you don’t meet every qualification, we encourage you to apply. Veterans, first responders, and those transitioning from military to civilian life bring valuable skills that strengthen our team.

Additional Information:

Applicants for this role must be authorized to work in the United States without further employer sponsorship.

Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting.

Important Notice Regarding Recruitment Scams: Veranova is committed to providing a professional and secure recruitment experience for all applicants. Unfortunately, fraudulent job postings and recruitment scams are becoming more prevalent. We want to ensure that all candidates are aware of potential scams. Please see our notice here.

• Legitimate communications from Veranova will only come from official email addresses using our domain: @veranova.com.


• Legitimate LinkedIn communications will only come from active Veranova employees.


• Veranova will never ask candidates for sensitive personal information during the application process (e.g., bank account details or social security number).


• Veranova will never ask candidates for payment (e.g., for equipment, training, or background checks).

If you have any doubts or concerns about the authenticity of a job posting, please reach out to our HR department: pharm.hr@veranova.com (US.

All your information will be kept confidential according to EEO guidelines.

Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.

All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.