Director Process Development Jobs in Pennsylvania

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Piramal Critical Care (PCC), a business unit of Piramal Pharma, is the fourth-largest producer of inhaled anesthetics and a global player in hospital generics. We are motivated by our vision of commitment to delivering critical care solutions for patients and healthcare providers across the globe while achieving sustainable and profitable growth for all the stakeholders.

PCC maintains a wide presence across the US, Europe, and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management.

PCC has a strong manufacturing and process development experience with wholly-owned, state-of-the-art manufacturing facilities in the United States and India, inspected periodically by the US FDA and the UK MHRA and other regulators. The strategic locations of our facilities help us supply high-quality products around the world, timely at optimal costs.

For more details, please visit https://www.piramalcriticalcare.com/global/

Job Title

Job Description

Essential Duties and Responsibilities

• Acts as SME for API manufacturing processes, utility systems, and unit operations including distillation, reactors, scrubbers, absorbers, and condensers.
• Accountable for process performance and drives improvements in yield, throughput, reliability, cost, and cycle time.
• Leads troubleshooting and root cause investigations for deviations, batch failures, and process upsets using data-driven and structured problem-solving methods.
• Develops and maintains mass and energy balances to support optimization and debottlenecking efforts.
• Applies Statistical Techniques (SPC, DOE, etc) to monitor capability, reduce variation, and improve process stability.
• Tunes and optimizes process control systems, including PID loops, to improve operational performance.
• Leads Lean and Six Sigma initiatives focused on measurable process improvement.
• Supports capital projects through design, implementation, commissioning, and startup activities.
• Drafts and reviews URSs, SOPs, Change Controls, validation documents, technical reports, and investigations.
• Leads or supports PHA/HAZOPs, MOC, and incident investigations.
• Partners closely with Operations, Maintenance, and Automation to implement practical, field-based solutions.
• Maintains strong plant presence and responds to plant upsets with urgency and sound engineering judgment.
• Mentors junior engineers and provides technical leadership across manufacturing issues.
• Drives execution with a bias toward action and measurable results.
• Other duties as assigned.

Key Competencies (knowledge, skills, and abilities every person must possess to be successful)

• Strong analytical and systems-thinking capability with ability to synthesize complex, multi-variable process data into clear technical conclusions and actionable decisions.
• Deep understanding of chemical engineering principles (thermodynamics, mass transfer, reaction engineering, fluid flow, heat transfer) applied to real manufacturing systems.
• Advanced problem-solving and critical thinking skills with demonstrated ability to independently resolve complex process issues in batch or continuous API manufacturing environments.
• Strong capability to interpret manufacturing data including historian data, batch records, process trends, and deviation histories to identify true drivers of performance.
• Working knowledge of Statistical Process Control (SPC) and statistical reasoning to assess process stability, variation, and capability.
• Strong understanding of pharmaceutical and chemical manufacturing systems including distillation, reactors, separations, heat transfer systems, and supporting utility networks.
• Working knowledge of Process Safety Management (PSM), including safe operation of high-hazard processes, operating envelopes, and risk-based controls.
• Experience working with or around highly hazardous chemical systems, including toxic, corrosive, and reactive materials such as chlorine and anhydrous HF, with strong safety awareness.
• Strong understanding of cGMP environments including validation, change control, deviation management, and regulatory compliance expectations.
• Ability to develop, interpret, and review technical documentation including URSs, SOPs, investigations, validation protocols, and engineering design packages.
• Strong leadership and influence capability with ability to align cross-functional teams and drive execution without direct authority.
• High bias toward action and decision-making, balancing technical rigor with urgency to ensure safe and reliable production performance.

Education/Experience

• Bachelor of Science in Chemical Engineering required.
• 8+ years of experience in chemical or pharmaceutical API manufacturing required; 10+ years preferred.
• Demonstrated expertise in troubleshooting and optimizing batch and/or continuous chemical processes in a cGMP manufacturing environment.
• Strong track record of driving measurable process improvements in yield, reliability, throughput, cost, or cycle time using data-driven methods.
• Lean Six Sigma Green Belt required; Black Belt strongly preferred with practical application in manufacturing environments.
• Experience with TrackWise, Aspen, SAP, and AutoCAD strongly preferred.

Physical Demands:

Physical Effort (Occurrence frequency for each activity)

Activity

N/A

Occasionally

Frequently

Continuously

Sitting/Standing/Walking: Continuously

Balancing/ Kneeling/Crouching/Stooping: Occasionally

Crawling/Climbing: Occasionally

Reaching/Working Overhead: Frequently

Keyboard Use/Repetitive Hand Motion: Continuously

Pushing/Pulling (up to 50 pounds): Occasionally

Lifting/Carrying (up to 50 pounds): Occasionally

Reporting to this position: N/A Individual Contributor

General Oversight and Direction:

Receives moderate to limited supervision working from objectives set by Manager. Employee organizes and carries out most assignments in accordance with standard practices, instructions or previous training. Employee handles some situations independently.

Equal Employment Opportunity

Piramal Critical Care is committed to Equal Employment Opportunity. It is the policy of the Company to encourage and support equal employment opportunity for all associates and applicants without regard to age, sex, race, color, ancestry, religious creed, national origin, pregnancy, physical or mental disability, medical condition, marital status, political affiliation, sexual orientation, disabled veteran or Vietnam Era Veteran Status.

Americans with Disabilities Act

Applicants as well as employees who are, or become, disabled must be able to perform the essential job functions either unaided or with reasonable accommodation. The organization shall determine reasonable accommodation on a case-by-case basis in accordance with applicable law.

Employee Job Responsibilities

You are expected to follow all policies, procedures and guidelines, conducting yourself in ways that protect the interests and safety of all employees and the company.

The above statements reflect the general duties and responsibilities considered necessary to perform the essential functions of the job. This document should not be considered a fully detailed description of all the work requirements of the position. Piramal Critical Care may change the specific job duties with or without prior notice based on the needs of the organization.