Senior Process Engineer

ADPS Group is seeking a Senior Process Engineer for a client in Boston, MA. The Senior Process Engineer is responsible for providing GXP Engineering support functions for various GxP Operations. The role will provide technical support, including drawing review, design review, specification review, project management, change control and commissioning for GMP manufacturing equipment and facilities in a manner compliant with regulatory expectations, company policy, and current procedures.

Roles & Responsibilities

• Execute change management for manufacturing equipment and other support systems, including commissioning and/or implementation of related initiatives.

• Execute assigned duties on time and within budget; proactively communicate delays and other issues to relevant stakeholders.

• Manage creation and revision of protocols, reports, and engineering documents including IOV, drawings, user requirement specifications and SOP’s.

• Effectively work with cross‑departmental stakeholders to achieve departmental goals and objectives.

• Supply Good Engineering Practice (GEP) expertise to troubleshoot facility, equipment or system issues.

• Balance innovative exploration with pursuit of project objectives and coordinate implementation / integration of new capabilities as appropriate.

Skills & Qualifications

• B.A., B.S. in Engineering or related discipline with at least 5 years of relevant experience or M.S. in a related field with 3 years of experience.

• Understanding and application of technical principles, theories, and concepts in GMP, ISO, GAMP, ANSI.

• Knowledge of facility‑related engineering disciplines (MEP) in GMP manufacturing environment, preferably oral solid dosage or related experience.

• Extensive hands‑on experience dealing with change controls.

• Excellent verbal and written communication skills applied on a global or multi‑national basis.

• Strong interpersonal skills, including the demonstrated ability to manage through influence.

Ideal Candidates

• Demonstrated planning and organizational skills, including complex project management.

• Ability to lead by influence.

• Experience in Design Documentation (URS, FRS, DS, and other engineering specifications), Validation (IQ, OQ, PQ, PV, CSV, MVP, etc.), and Quality Systems (Change Control, Non‑Conformances, Requalification, etc.).

• Fosters change and innovation – seeks solutions that strengthen quality, value, service and effectiveness.

• Demonstrates business acumen and agility – engages in effective operational and strategic planning.

• Accountable for results – translates goals/objectives into actionable plans and results.

• Capable of managing multiple projects and various priorities and timelines.

• Ability to review Engineering Documents and Models (CAD, Revit, etc.).

• Proficient in Project Management tools.

Additional Expectations

• Continuous learning – assesses strengths and weaknesses, pursues training opportunities, shares expertise, and strives to continually build knowledge and skills.

• Culture – supports a culture of excellence and contributions to a collaborative environment that rewards teamwork and mentorship.

• Customer services – displays courtesy and sensitivity, manages difficult customer situations, meets commitments, and solicits feedback.

• Planning and organizing – prioritizes work activities, uses time efficiently, and integrates changes smoothly.

• Teamwork – balances team and individual responsibilities, contributes to positive team spirit, and gives and welcomes feedback.

• Use of technology – demonstrates required skills, adapts to new technologies, and troubleshoots problems to increase productivity.

• Language ability – reads and interprets documents, writes routine reports, and speaks effectively before groups.

• Mathematical and reasoning ability – applies mathematical concepts and common sense understanding to carry out instructions.

About the Company

ADPS Group is a global EPCMV firm offering full-service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries. ADPS is dedicated to delivering successful projects with a ‘client‑first’ mentality and personal touch across a range of market sectors:
Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start‑up.

Equal Opportunity Employer

ADPS Engineering Inc. is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. ADPS does not discriminate in employment opportunities or practices on the basis of: race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status or any other characteristic protected by law.

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