Global Pharmaceutical SME

Flowserve Corporation; Yorktown (VA); On-site; USD 173,000 - 260,000; Full time

Benefits offered by this job

Competitive Base Salary

Medical, Dental & Vision Insurance

401(k) Retirement Savings Plan with 1:

Paid Time Off and Holidays

Parental Leave

Life/AD&D Insurance

Global Career Mobility

Job summary

Flowserve Corporation seeks a Global Pharmaceutical Subject Matter Expert (SME) to lead regulatory alignment, technical credibility, and commercial strategy across expanding life sciences initiatives. You will translate biopharmaceutical standards into actionable commercial roadmaps and customer partnerships.

You will bridge bioprocess engineering, regulatory governance, and cross-functional teams, driving adoption of CIP/SIP, validation, and quality systems while expanding global pharmaceutical

Qualifications

• Bachelor's degree in Engineering (Biomedical, Chemical, Mechanical), Life Sciences (Biochemistry, Biology, Pharmacology), Business, or a closely related discipline.
• 8+ years of industry experience across pharmaceutical manufacturing, bioprocess engineering, or life sciences quality/regulatory affairs.
• Substantial background working with or alongside a regulatory agency, health authority (e.g., FDA, EMA, MHRA), or senior regulatory-compliance/quality leadership role.
• In-depth expertise in cGMP regulations, ASME BPE standards, cleanroom classifications, CIP/SIP cycle dynamics, clean utilities, and validation lifecycles (IQ/OQ/PQ).
• Translate health authority guidance, regulatory compliance needs, and quality audit findings into commercial product requirements and operational practices.
• Exceptional communication, executive presentation, and cross-functional leadership skills with ability to influence globally.
• Willingness to travel globally up to 30%–40% for audits, integrations, trials, and events.
• Legally authorized to work in the United States without sponsorship.

Responsibilities

• Serve as the primary Voice of the Customer (VoC) translating biopharmaceutical requirements into engineering, operational, and commercial priorities.
• Provide expert regulatory guidance regarding health authority expectations, change control, documentation, supplier qualification, material traceability, and risk mitigation.
• Partner with Product Management and R&D to guide roadmaps, launch-readiness criteria, and commercialization strategies for sterile, sanitary, and bioprocess environments.
• Cultivate strategic relationships across global pharmaceutical manufacturers, bioprocess skid integrators, and industry groups.
• Spearhead market execution and account-penetration strategies in high-growth areas like cell/gene therapy, monoclonal antibodies, API synthesis, and bulk biologics.
• Support trials, pilot evaluations, reference installations, symposiums, and global industry roadshows.
• Collaborate with Global Sales, Marketing, and Supply Chain on value propositions, validation dossiers, and sales-enablement materials.
• Perform market surveillance, regulatory intelligence, and benchmarking to identify high-value accounts and partnerships.
• Present strategic initiatives and progress to executive leadership.

Skills

Regulatory affairs

cGMP compliance

Cross-functional leadership

Global market strategy

Education

Bachelor's degree in Engineering or Life Sciences

Advanced degree preferred

Tools

ISPE PDA

Job description

Flowserve is seeking an accomplished Global Pharmaceutical Subject Matter Expert (SME) to lead regulatory alignment, technical credibility, and commercial strategy across our expanding life sciences initiatives. In this high-visibility global role, you will serve as the principal regulatory and manufacturing authority—translating strict biopharmaceutical standards, current Good Manufacturing Practice (cGMP), and health authority expectations into actionable commercial strategies, product roadmaps, and customer partnerships.

Operating at the intersection of life sciences engineering and regulatory governance, you will bridge the gap between global pharmaceutical end users, bioprocess OEMs, skid builders, and Flowserve's cross-functional engineering, sales, and product teams. Your deep understanding of clean-in-place/steam-in-place (CIP/SIP) applications, validation protocols, quality systems, and inspection readiness will accelerate technology adoption, elevate our brand credibility, and drive market expansion across global pharmaceutical and bioprocess sectors.

Key Responsibilities

• Serve as the primary Voice of the Customer (VoC), translating complex biopharmaceutical process, cGMP, validation, and regulatory compliance requirements into tangible engineering, operational, and commercial priorities.
• Provide expert regulatory guidance to cross-functional engineering, quality, operations, and commercial teams regarding health authority expectations, change control, documentation, supplier qualification, material traceability, and regulatory risk mitigation.
• Partner directly with Product Management and R&D to guide product roadmaps, launch-readiness criteria, and commercialization strategies tailored for sterile, sanitary, and bioprocess environments.
• Cultivate and expand strategic relationships across global pharmaceutical manufacturers, drug development organizations, bioprocess skid integrators, academic institutions, and industry working groups.
• Spearhead market execution and account-penetration strategies targeting high-growth areas, including cell/gene therapy, monoclonal antibodies, active pharmaceutical ingredient (API) synthesis, and bulk biologics.
• Support high-profile customer trials, pilot evaluations, reference installations, technical symposiums, and global industry roadshows.
• Collaborate with Global Sales, Marketing, and Supply Chain to construct differentiated value propositions, customer validation dossiers, and consultative sales-enablement materials.
• Perform continuous market surveillance, regulatory intelligence gathering, and competitive benchmarking to identify high-value customer accounts and strategic OEM design-in partnerships.
• Present strategic market initiatives, compliance frameworks, technology readiness assessments, and commercial progress directly to executive leadership.

Required Qualifications

• Bachelor's degree in Engineering (Biomedical, Chemical, Mechanical), Life Sciences (Biochemistry, Biology, Pharmacology), Business, or a closely related discipline.
• 8+ years of industry experience across pharmaceutical manufacturing, bioprocess engineering, or life sciences quality/regulatory affairs.
• Substantial background working within or closely alongside a regulatory agency, health authority (e.g., FDA, EMA, MHRA), notified body, or in a senior regulatory-compliance/quality leadership role within an enterprise pharmaceutical manufacturer.
• In-depth expertise in cGMP regulations, ASME BPE standards, cleanroom classifications, CIP/SIP cycle dynamics, clean utilities, and validation lifecycles (IQ/OQ/PQ).
• Proven ability to translate complex health authority guidance, regulatory compliance needs, and quality audit findings into commercial product requirements and operational practices.
• Exceptional communication, executive presentation, and cross-functional leadership skills with the ability to influence C-suite, engineering, and regulatory stakeholders globally.
• Willingness and ability to travel globally up to 30%–40% to support customer audits, OEM integrations, pilot trials, and industry events.
• Legally authorized to work in the United States without company sponsorship.

Preferred Qualifications

• Advanced degree (Master of Science, MBA, or Ph.D.) in Engineering, Life Sciences, or Regulatory Affairs.
• Direct hands-on exposure to fluid motion systems, rotating equipment, sterile valves, sanitary mechanical seals, or clean-utility pumping systems in life sciences facilities.
• Established active relationships with engineering leaders at major pharmaceutical manufacturers (e.g., Pfizer, Eli Lilly, Merck, Roche, Novartis) and premier bioprocess skid integrators.
• Active participation or leadership within industry trade groups (e.g., ISPE, PDA, ASME BPE).

What We Can Offer You

At Flowserve, you'll find a range of options to fit your, and your family's, needs. We want to provide our team with the right resources to invest in your physical, mental and financial well-being no matter where you sit or what stage of life you're in.

Our benefits include:

• Competitive Base Salary with Global Annual Incentive Bonus
• Medical, Dental & Vision Insurance with Flexible Spending (FSA) and Health Savings Accounts (HSA)
• 401(k) Retirement Savings Plan with Immediate Company Match
• Short-Term and Long-Term Disability Protection
• Paid Time Off (PTO) and Company-Paid Holidays
• Comprehensive Parental Leave
• Life, Supplemental Life, Child, Spousal, and AD&D Insurance
• Global Career Mobility & Executive Development within an S&P 500 Industry Leader

The pay range for this role is $172,930.93 - $259,518.35 per year.