Sterile Process Engineer, Specialist (On-site)

We need to output HTML fragment with sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. Must not repeat job title. Must not include Job ID etc. Must preserve all substantive info. Remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning, duplicated lines, application instructions. Also remove lines like "Current Employees apply HERE", "Current Contingent Workers apply HERE", "US And Puerto Rico Residents Only", "Our company is committed to inclusion...", "Requirements As an Equal Employment Opportunity Employer..." etc. Also remove "Search Firm Representatives Please Read Carefully..." etc. Also remove "Employee Status Regular Relocation: Domestic VISA Sponsorship No Travel Requirements 10% Flexible Work Arrangements Not Applicable Shift 1st - Day Valid Driving License No Hazardous Material(s) n/a Job Posting End Date 09/25/2026 ..." etc. Also remove "FLEx2026 Sterile2026 VETJOBS EligibleforERP". Also remove "Required Skills Aseptic Processing, cGMP Guidelines, ..." maybe that is skills list; we can keep under Skills section. Also "Preferred Skills Current Employees apply HERE ..." remove. We need to extract substantive content: - About the role: description of FLEx Center, role purpose, responsibilities: "The Formulation, Laboratory, and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing facility in Rahway, New Jersey. The Sterile Process Engineer role at the Specialist level will leverage the individual’s leadership, technical, and communication skillsets to drive the success of our clinical manufacturing facility and organization. This role will support the pipeline’s most technically complex formulations and process development through process tech transfer, scale-up activities, quality investigations, change management, and authoring GMP standard operating procedures and protocols in support of sterile clinical drug product operations. This individual will collaborate closely with the formulation scientists, engineers, operations staff, quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ultimately to enable the flexibility and speed of our Company's pipeline. The role is, on-site, based in New Jersey and reports to the Sterile Process Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Device Development (PSDD)." We can split into About the role (overview) and Responsibilities (list). Responsibilities: process tech transfer, scale-up activities, quality investigations, change management, authoring GMP SOPs and protocols, collaborate with formulation scientists, engineers, operations staff, quality reps, other team members to ensure quality, scientific rigor, enable flexibility and speed. Education Minimum Requirements: Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 3 years relevant experience; Master’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field (with expected completion no later than June 2027). That's qualifications. Required Experience And Skills: list: Excellent enterprise leadership skill demonstration; Excellent interpersonal and communication skills, both verbal and written.; Experience in leading quality investigations and change management.; Familiarity with United States and European Union GMP and Safety compliance regulations.; Ability to convert new drug product attributes and process needs to an executable series of steps and procedures to enable acceptable product manufacture.; Ability to prepare Standard Operating Procedures (SOP) and current GXP documents.; Experience with quality systems.; Excellent organizational skills.; Desire and willingness to learn, contribute and lead.; Track-record of independent problem-solving. Preferred Experience And Skills: Experience with sterile GMP facility operations.; Knowledge of Investigational drug regulatory requirements.; Understanding of Clinical Supply Chain Operations.; Expertise in drug product aseptic processing, equipment, and sterile technique. Required Skills list: Aseptic Processing, cGMP Guidelines, Electronic Batch Records, Laboratory Experiments, Pharmaceutical Regulatory Compliance, Pharmaceutical Sciences, Pilot Plant Operations, Process Engineering, Process Improvements, Standard Operating Procedure (SOP), Sterile Manufacturing, Technology Transfer, Troubleshooting Preferred Skills: maybe none else. Benefits: "We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days." Pay: "The salary range for this role is $87,300.00 - $137,400.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable." Schedule: Not explicitly given. There's "Shift 1st - Day" maybe indicates shift? Also "Travel Requirements 10%" maybe travel. But schedule not clearly defined. The instruction: never create Pay/Schedule/Benefits sections unless posting actually states them. Pay is stated. Benefits is stated. Schedule? There's "Shift 1st - Day" maybe indicates work shift. Could treat as schedule? But it's ambiguous. There's also "Flexible Work Arrangements Not Applicable". Might be considered schedule info. However, we should only include Schedule if there is real specific content. The posting includes "Shift 1st - Day". That's a specific shift. Could include Schedule section with that. But also "Travel Requirements 10%" maybe not schedule. I'd include Schedule with shift info. We must not include boilerplate like "Job Posting End Date", "Requisition ID". Also remove "FLEx2026 Sterile2026 VETJOBS EligibleforERP". Also remove "Required Skills Aseptic Processing, ..." maybe we keep as skills list. We need to use

for section headings. Use

• for any list of duties/requirements/benefits. Use

  for prose. We need to decide sections: About the role (overview), Responsibilities, Qualifications (education), Requirements (maybe required experience/skills), Skills (maybe required/preferred skills), Benefits, Pay, Schedule. We must not repeat job title. Avoid duplication. Let's craft:

  About the role

  The Formulation, Laboratory, and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing facility in Rahway, New Jersey. The Sterile Process Engineer role at the Specialist level will leverage the individual’s leadership, technical, and communication skillsets to drive the success of our clinical manufacturing facility and organization. This role will support the pipeline’s most technically complex formulations and process development through process tech transfer, scale-up activities, quality investigations, change management, and authoring GMP standard operating procedures and protocols in support of sterile clinical drug product operations. This individual will collaborate closely with the formulation scientists, engineers, operations staff, quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ultimately to enable the flexibility and speed of our Company's pipeline. The role is on-site, based in New Jersey and reports to the Sterile Process Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Device Development (PSDD).

  Responsibilities

  • Lead process technology transfer and scale-up activities
  • Conduct quality investigations and change management
  • Author GMP standard operating procedures (SOPs) and protocols for sterile clinical drug product operations
  • Collaborate with formulation scientists, engineers, operations staff, quality representatives, and other team members
  • Ensure quality of clinical supplies and scientific rigor of processes
  • Enable flexibility and speed of the company's pipeline

  Qualifications

  • Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 3 years relevant experience
  • Master’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field (expected completion no later than June 2027)

  Requirements

  • Demonstrated enterprise leadership
  • Excellent interpersonal and communication skills, both verbal and written
  • Experience leading quality investigations and change management
  • Familiarity with United States and European Union GMP and safety compliance regulations
  • Ability to convert new drug product attributes and process needs into executable steps and procedures for acceptable product manufacture
  • Ability to prepare Standard Operating Procedures (SOP) and current GXP documents
  • Experience with quality systems
  • Excellent organizational skills
  • Desire and willingness to learn, contribute, and lead
  • Track record of independent problem‑solving

  Skills

  • Aseptic Processing
  • cGMP Guidelines
  • Electronic Batch Records
  • Laboratory Experiments
  • Pharmaceutical Regulatory Compliance
  • Pharmaceutical Sciences
  • Pilot Plant Operations
  • Process Engineering
  • Process Improvements
  • Standard Operating Procedure (SOP)
  • Sterile Manufacturing
  • Technology Transfer
  • Troubleshooting
  • Experience with sterile GMP facility operations (preferred)
  • Knowledge of investigational drug regulatory requirements (preferred)
  • Understanding of Clinical Supply Chain Operations (preferred)
  • Expertise in drug product aseptic processing, equipment, and sterile technique (preferred)

  Benefits

  • Medical, dental, vision healthcare and other insurance benefits (employee and family)
  • Retirement benefits, including 401(k)
  • Paid holidays, vacation, and compassionate and sick days

  Pay

  The salary range for this role is $87,300.00 – $137,400.00. An employee’s position within the range is based on relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate is eligible for annual bonus and long‑term incentive, if applicable.

  Schedule

  Shift: 1st – Day (on‑site, New Jersey)

  We must ensure no duplicate content. Also ensure we didn't include boilerplate like "US And Puerto Rico Residents Only", etc. We removed those. Check that we didn't include any mention of "EEO", "Equal Employment Opportunity", etc. Good. Check that we didn't include "Current Employees apply HERE". Not included. Check that we didn't include "Job Posting End Date". Not included. Check that we didn't include "FLEx2026 Sterile2026 VETJOBS EligibleforERP". Not included. Check that we didn't include "Required Skills Aseptic Processing, cGMP Guidelines, Electronic Batch Records, Laboratory Experiments, Pharmaceutical Regulatory Compliance, Pharmaceutical Sciences, Pilot Plant Operations, Process Engineering, Process Improvements, Standard Operating Procedure (SOP), Sterile Manufacturing, Technology Transfer, Troubleshooting". We turned that into list under Skills. Check that we didn't include "Preferred Skills Current Employees apply HERE Current Contingent Workers apply HERE". Not included. Check that we didn't include "Our company is committed to inclusion..." Not included. Check that we didn't include "Requirements As