Job Description

Quality Assurance & Commissioning/Qualification Engineer (Medical Device & Pharmaceutical Manufacturing)

Brooksource Engineering Services

Pharmaceutical Manufacturing Client

Contract Consulting Opportunity

Position Overview

Brooksource Engineering Services is seeking a Quality Assurance & Commissioning/Qualification Engineer to support a leading pharmaceutical manufacturing client. This individual will play a critical role in ensuring manufacturing processes, equipment, and systems are designed, qualified, and validated to meet quality and regulatory requirements. The consultant will partner with engineering, quality, manufacturing, validation, and supplier teams to support new product introductions, technical transfers, manufacturing readiness activities, and continuous improvement initiatives. This role is ideal for professionals with experience in quality systems, commissioning and qualification (C&Q), medical device manufacturing, process validation, supplier quality, or pharmaceutical manufacturing operations.

Key Responsibilities

• Provide quality oversight throughout equipment, process, and manufacturing system commissioning, qualification, and commercialization activities.
• Ensure manufacturing process designs meet quality and regulatory requirements while identifying and mitigating risks to product quality.
• Verify equipment and manufacturing systems are fit for intended use through qualification and validation activities.
• Support manufacturing readiness assessments for suppliers and contract manufacturing organizations (CMOs).
• Evaluate quality management systems, training programs, maintenance programs, and manufacturing processes to ensure operational readiness.
• Provide quality support for technical transfers involving medical device and pharmaceutical manufacturing operations.
• Participate in design reviews to ensure manufacturability, compliance, and product quality considerations are appropriately addressed.
• Support process validation, equipment qualification, and manufacturing process implementation activities.
• Review and assess change control activities, equipment modifications, and manufacturing process improvements.
• Partner with engineering and manufacturing teams on risk assessments, including Process Failure Mode and Effects Analysis (pFMEA).
• Support internal audits, quality investigations, and continuous improvement initiatives.
• Serve as a quality representative for computer system validation (CSV) activities, including document review and approvals where applicable.
• Provide ongoing quality support for both newly commercialized and existing products.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Chemistry, Biology, or a related technical discipline.
• 3+ years of experience in pharmaceutical, biotechnology, medical device, or regulated manufacturing environments.
• Experience supporting one or more of the following:
• Quality Assurance
• Commissioning & Qualification (C&Q)
• Process Validation
• Computer System Validation (CSV)
• Manufacturing Engineering
• Technical Services
• Supplier Quality
• Medical Device Manufacturing
• Working knowledge of quality systems, validation methodologies, and regulated manufacturing practices.
• Strong technical writing, documentation, and communication skills.
• Ability to work cross-functionally with engineering, quality, manufacturing, validation, and supplier teams.

Preferred Qualifications

• Knowledge of FDA and global regulatory requirements, including:
• 21 CFR Parts 11, 210, 211, and 820
• ISO 13485
• ISO 14971
• Global medical device and pharmaceutical quality standards
• Experience working with contract manufacturers, suppliers, or external manufacturing partners.
• Familiarity with risk management methodologies, including FMEA.
• Experience supporting computer system validation and electronic quality systems.
• Knowledge of change control, deviation management, CAPA, and quality management system processes.
• Experience with quality management platforms such as Veeva, TrackWise, or similar systems.
• Basic statistical analysis and data interpretation skills.

Desired Competencies

• Strong problem-solving and decision-making abilities.
• Excellent organizational and time-management skills.
• High attention to detail and commitment to quality.
• Effective written and verbal communication skills.
• Ability to explain quality and validation concepts to technical and non-technical stakeholders.
• Demonstrated ability to work independently and collaboratively within cross-functional teams.

Travel Requirements

• Ability to travel may be required to support supplier, contract manufacturing, and quality oversight activities, including occasional international travel.

About Brooksource Engineering Services

Brooksource Engineering Services delivers specialized engineering and technical consulting solutions to pharmaceutical, biotechnology, manufacturing, and medical device organizations. Our consultants partner with industry-leading clients to support critical initiatives across quality, validation, commissioning, manufacturing, automation, and operational excellence. This position offers the opportunity to contribute to highly regulated manufacturing environments while driving product quality, compliance, and operational readiness.

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