Senior Process Engineer

Job Description
BioTechnique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fill-finish services.From IND applications through commercial scale production, we provide formulation and compounding, fill-finish, and lyophilization services for a wide variety of liquid injectables. BioTechnique utilizes our team's expertise to create a process design for our clients' products that best suits their needs.

The Experience

With operations spanning the globe and featuring a multi-cultural team, BioTechnique is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered a compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At BioTechnique, it's about more than just a job-it's about your career and your future.

Your Role

BioTechnique is seeking a highly motivated Senior Process Engineer to support aseptic manufacturing, technology transfer, process validation, and continuous improvement activities within our sterile injectable CDMO operations. This role serves as a technical leader responsible for translating client manufacturing processes into robust, scalable, and compliant commercial operations.


The Senior Process Engineer will collaborate across Manufacturing, Quality, Validation, Facilities, Metrology, Supply Chain, and Client Project Teams to support aseptic fill-finish programs from development through commercial production. The successful candidate will possess a strong understanding of aseptic processing, sterile manufacturing, cGMP requirements, process validation, and pharmaceutical engineering principles.

Process Development & Technology Transfer

• Lead process transfer activities from clients into BioTechnique manufacturing operations.
• Review client process documentation, batch records, process descriptions, and development reports.
• Develop manufacturing process strategies for aseptic fill-finish, sterile filtration, compounding, lyophilization, and packaging operations.
• Author and review technology transfer protocols, reports, risk assessments, and process characterization documents.
• Support engineering runs, water runs, media fills, and demonstration batches.

Manufacturing Support

• Provide floor support during aseptic manufacturing campaigns.
• Troubleshoot process deviations, equipment issues, yield losses, and process excursions.
• Support investigations, CAPAs, and root cause analyses.
• Drive process improvements that increase throughput, quality, and operational efficiency.
• Provide technical leadership during critical manufacturing operations.

Process Validation

• Author and execute:
• Process Validation Master Plans (PVMP)
• PPQ Protocols and Reports
• Continued Process Verification (CPV) Programs
• Process Risk Assessments
• Media Fill Protocols
• Analyze process data and recommend improvements based on statistical and scientific principles.
• Support successful execution of PPQ campaigns.

Aseptic Processing Support

• Support aseptic processing programs in compliance with:
• FDA cGMP regulations
• EU GMP Annex 1
• ICH Guidelines
• USP requirements
• Participate in aseptic process simulations (APS/media fills).
• Evaluate smoke studies, environmental monitoring trends, contamination control strategies, and operator qualification programs.
• Support contamination control and sterility assurance initiatives.

Equipment & Facility Engineering

• Support qualification and implementation of:
• Filling lines
• Isolators
• RABS systems
• Lyophilizers
• CIP/SIP systems
• Sterile filtration systems
• Compounding equipment
• Visual inspection systems
• Collaborate with Validation and Facilities teams during IQ/OQ/PQ activities.
• Assess equipment performance and recommend improvements.

Lyophilization Support

• Support cycle development, scale-up, and process optimization activities.
• Review thermal characterization and freeze-drying data.
• Support lyo process validation and technology transfer projects.
• Investigate cycle anomalies and process variability.

Continuous Improvement

• Lead Lean Manufacturing and Operational Excellence initiatives.
• Utilize data analytics and process monitoring tools to improve performance.
• Support OEE improvement programs.
• Implement process robustness and reliability improvements.

Regulatory & Audit Support

• Support internal and external audits.
• Participate in client audits and regulatory inspections.
• Provide SME support during FDA and customer inspections.
• Prepare technical documentation for regulatory submissions when required.

Requirements

• Bachelor's degree in: Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, Biotechnology, Related Engineering Discipline
• 7+ years of pharmaceutical manufacturing experience.
• Minimum 3 years supporting aseptic manufacturing operations.
• Must be authorized to work in the U.S.
• No C2C at this time.
• Demonstrated experience with:
• Sterile injectable manufacturing
• Fill-finish operations
• GMP documentation
• Process investigations
• Technology transfer
• Process validation

Preferred

• Experience in a CDMO environment.
• Experience supporting biologics, vaccines, mAbs, gene therapy products, peptides, or sterile small molecules.
• Experience with lyophilization cycle development and optimization.
• Familiarity with Annex 1 contamination control requirements.
• Project management experience.
• Six Sigma Green Belt or Black Belt certification.

Benefits

Offering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.

• Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
• Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
• 401(k) and 401(k) matching
• PTO, Sick Time, and Paid Holidays
• Education Assistance
• Pet Insurance
• Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more)
• Financial Perks and Discounts

Equal Opportunity Employment Statement

PSC is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs,including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.

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