Manufacturing & Tech Ops - Engineer III - Project Farma

This is a full-time salaried position with Project Farma, a PerkinElmer company. The successful candidate will reside in one of Project Farmas primary markets and be willing to travel domestically to meet client project requests.

Project Farmas purpose is to improve patient lives by accelerating the delivery of life-changing therapies. We accomplish this through the successful execution of high-quality life sciences projects across the full project lifecycle. Project Farma (PF) team members collaborate with cross-functional teams to build trusted client relationships, deliver an exceptional customer experience, and contribute to business growth by identifying opportunities and applying data-driven insights to support project planning, cost, schedule, and performance management.

All team members are expected to embody Project Farmas values by being curious , personable , and unselfish , while maintaining a strong commitment to a Patient Focused and People First mindset .

The Manufacturing & Tech Ops - Engineer III is an experienced technical leader who serves as a subject-matter expert and drives complex workstreams from planning through execution. This role applies advanced technical expertise and strong understanding of project objectives to solve complex problems, influence technical direction, and deliver high-quality outcomes. These Engineers independently lead workstreams, proactively identify risks and improvement opportunities, and ensure alignment with client and business expectations. They act as trusted advisors to project teams and stakeholders while demonstrating leadership through mentorship, quality ownership, and cross-functional collaborations. This role requires strategic problem-solving, sound judgement, and a high level of accountability in driving results.

Key Responsibilities

The Manufacturing & Tech Ops - Engineer III serves as the technical subject matter expert responsible for supporting the commercial manufacture, technology transfer, process validation, process optimization, and lifecycle management of biopharmaceutical manufacturing processes. This position acts as the primary technical interface between Process Development, Manufacturing, Quality, Engineering, Regulatory Affairs, Supply Chain, and external manufacturing partners to ensure robust, compliant, and efficient production operations.

The Manufacturing & Tech Ops - Engineer III provides scientific leadership for troubleshooting manufacturing issues, evaluating process performance, implementing process improvements, supporting investigations, and ensuring manufacturing processes remain in a validated state throughout the product lifecycle. The individual applies scientific principles, engineering knowledge, statistical analysis, and quality risk management to improve manufacturing robustness while maintaining regulatory compliance and product quality.

Primary Responsibilities

Manufacturing Support

• Provide technical support to GMP manufacturing operations for clinical and commercial products.

• Serve as the primary technical contact during manufacturing campaigns.

• Evaluate process performance and recommend improvements to increase robustness, yield, and process capability.

• Support manufacturing deviations, nonconformances, and investigations by identifying root causes and implementing effective corrective and preventive actions (CAPA).

• Assess manufacturing trends and identify opportunities for continuous improvement.

Process Validation

• Develop and execute process validation strategies, including process validation master plans (PVMP), process performance qualification (PPQ), continued process verification (CPV), and lifecycle validation activities.

• Author and review validation protocols and reports.

• Evaluate validation data using statistical tools and process capability analyses.

• Support qualification of new manufacturing equipment and process changes.

• Understanding of general process validation requirements for FDA and EMA.

Technology Transfer

• Provide tech transfer leadership and expertise for new processes in multiple modalities, creating all elements, including MBRs, PDs, process risk assessments (FMEA, e.g.), etc., necessary for a successful transfer.

• Lead technology transfer activities from process development into manufacturing.

• Support transfer of manufacturing processes between internal sites and contract manufacturing organizations (CMOs).

• Ensure manufacturing documentation accurately reflects process knowledge and design intent.

• Coordinate transfer readiness assessments and risk evaluations.

Process Monitoring and Lifecycle Management

• Monitor critical process parameters (CPPs) and critical quality attributes (CQAs).

• Analyze process trends using statistical methods.

• Support implementation of Continued Process Verification programs.

• Recommend process improvements based on manufacturing performance data.

Investigations and Technical Problem Solving

• Lead scientific investigations for manufacturing deviations, out-of-specification (OOS) events, and atypical results.

• Perform data-driven root cause analyses.

• Evaluate manufacturing process variability.

• Develop technically justified corrective and preventive actions.

Documentation

• Author, review, and approve:

• Technical reports

• Process Validation Master Plan

• Process validation protocols and reports

• Risk assessments (Process FMEAs)

• Manufacturing support documents

• Change controls

• Technical assessments

• Standard Operating Procedures (SOPs)

• Batch record revisions

Cross-Functional Collaboration

• Partner with Manufacturing, Process Development, Quality Assurance, Quality Control, Engineering, Supply Chain, Regulatory Affairs, and external partners.

• Provide technical input during regulatory inspections and customer audits.

• Support regulatory submissions by preparing technical documentation.

Typical Daily Responsibilities

A typical day may include:

• Reviewing manufacturing batch records and process data.

• Monitoring ongoing production campaigns.

• Supporting manufacturing floor operations during critical processing steps.

• Participating in deviation investigations and root cause analyses.

• Leading cross-functional technical meetings.

• Evaluating statistical process trends and process capability.

• Writing or reviewing transfer and validation documentation.

• Assessing proposed process changes through quality risk management.

• Collaborating with Process Development on process improvements.

• Supporting equipment qualification and implementation activities.

• Reviewing Continued Process Verification data.

• Responding to manufacturing questions from Operations personnel.

• Presenting technical findings to management and project teams.

Experience

• Experience supporting GMP biopharmaceutical manufacturing.

• Working knowledge of process validation and lifecycle process validation.

• Experience supporting and executing technology transfer activities.

• Familiarity with manufacturing investigations and deviation management; leading moderate to complex manufacturing investigations; presenting conclusions to clients/ leadership

• Experience analyzing manufacturing data using statistical methods.

• Knowledge of and experience with process monitoring and Continued Process Verification, interpreting data trends, and proactively leading manufacturing intervention based on data presented.

• Experience authoring technical documentation within a GMP quality system.

• Ability to support cross-functional manufacturing teams in a fast-paced environment.

Preferred Qualifications

• Experience supporting commercial manufacturing.

• Experience working with contract manufacturing organizations (CMOs).

• Knowledge of Quality by Design (QbD) principles.

• Experience with process characterization studies.

• Familiarity with statistical software such as JMP, Minitab, or similar analytical tools.

• Experience applying Quality Risk Management principles (e.g., FMEA, risk assessments).

• Knowledge of process analytical technology (PAT).

• Experience with technology transfers across manufacturing sites.

• Experience supporting regulatory inspections by FDA, EMA, MHRA, PMDA, or other health authorities.

Technical Knowledge

The successful candidate should possess knowledge of:

• GMP manufacturing operations

• Process validation lifecycle

• Process Performance Qualification (PPQ)

• Continued Process Verification (CPV)

• Technology transfer

• Process characterization

• Statistical process control

• Design of Experiments (DOE)

• Root cause analysis methodologies

• Quality Risk Management (ICH Q9)

• Pharmaceutical Quality System principles (ICH Q10)

• Process development fundamentals

• Manufacturing investigations

• Data analysis and trending

• Equipment qualification

• Change management

• Regulatory expectations for commercial manufacturing

• ATMPs, EU Guidelines, etc.

Core Competencies

• Strong scientific and technical problem-solving skills

• Excellent written and verbal communication

• Ability to interpret complex manufacturing data

• Critical thinking and analytical reasoning

• Effective cross-functional collaboration

• Project management and organizational skills

• Ability to prioritize multiple projects simultaneously

• Sound technical judgment and decision-making

• Attention to detail and commitment to quality

• Continuous improvement mindset

Industry Training Typically Expected

Successful candidates typically possess training or practical experience in:

• Good Manufacturing Practices (GMP)

• Good Documentation Practices (GDP)

• Data Integrity (ALCOA+)

• Process Validation

• Continued Process Verification

• Technology Transfer

• Root Cause Analysis (5 why, fishbone, KT, etc.)

• Quality Risk Management (ICH Q9)

• Pharmaceutical Quality Systems (ICH Q10)

• Quality by Design (ICH Q8)

• Change Control

• Deviation and CAPA Management

• Statistical Process Control

• Design of Experiments (DOE)

• Regulatory inspection readiness

• Lean Manufacturing and Continuous Improvement methodologies

• Manufacturing execution systems (MES) and electronic batch record systems (preferred)

• Environmental Health and Safety (EHS) requirements applicable to GMP manufacturing

Attributes for Success

• Technical Delivery : Applies advanced technical knowledge and professional expertise

• Innovation & Continuous Improvement : Seeks better ways, adapts to change and champions new ideas.

• Customer Focus & Professionalism : Represents PF with consistent professionalism, appropriate escalation and respect for internal stakeholders, even during high stress delivery situations

• Integrity & Humility : Demonstrates self-awareness and puts PF mission above ego

• Collaboration & Communication : Communicates clearly and proactively and drives transparent alignment with clients.

• Project Execution : Delivers reliably, manages priorities and drives for high quality outcomes

• Growth Mindset : Shows openness to new ideas, feedback and change

Experience Required

• Bachelors Degree in Life Science, Engineering, or related discipline (OR a combination of equivalent work experience in capital project engineering, pharma cGMP facility start-up, CapEx/OpEx project management and/or comparable military experience.
• Years of Experience

• Engineer III: 4-8 years required

• Travel : Willingness to travel asrequiredfor client project assignments.

Other Preferred

• OHSA 10 or 30

• Lean/ Six Sigma Blue, Green, and / or Black Belt certification(s) are a plus

Project Farma is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.

Applicants must be authorized to work in the United States on a full-time basis. We will not sponsor applicants for current or future work visas for this position. This position may require significant travel to support project and business needs. We cannot employ anyone with an invalid drivers license.

The annualcompensation range for this full-time position is $(74,000 - $95,000). The final base pay offered to the successful candidate will be determined by factors including internal equity, work location, as well as individual qualifications, such as job-related skills, experience, and relevant education or training.

VEVRAA Federal Contractor.
We request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.

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